510K: K101073,P,K113224 Item Numbers: 47494502601

Orthopedic Devices

2

Yes

Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON DELIVERY SERVICE (LYNBROOK NY) MALAYSIA MEXICO MIAMI FL MOROCCO NETHERLANDS NEW ZEALAND NICARAGUA PANAMA PERU PHARR TEXAS POLAND PUERTO RICO RIO DE JANEIRO SAUDI ARABIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND THE NETHERLANDS TRIPOLI UK VIRGIN ISLANDS VA/DOD: Both see addresses below

4.5 BROAD SCP PLT 26-H STER

510K:K083497, K082770 Item Numbers: 47249146014 47249246014 47249246114 47249538014 47249540014 47249542014 47249544014 Lot Numbers: 61103290 61103290V 61138671 61138682 61138671V 61138682V 61138676 61138687 61138676V 61138687V 61103287 61103287V 61103281 61103283 61103281V 61103283R 61103283V 61180209 112352 61202807 61205842 61202807R 61205842R 61202808 61202808R 61205846 61187350 61187350R 61218276 61218276R 61216615 61223061 61230526 61229396 61229407 61229396R 61229407R 61245120 61245155 61260972 112919 61237017 61263494 61260970 61260970R 61256429 61273711 61187351 61273717 61277263 61187351R 61279018 61289441 61277247 61283862 61283873 112952 112774 61301593 61306420 61301600 61318941 61318947 61314858 61318980 61326405 61326398 61330162 61326398R 61328635 61332013 61328635R 61332013R 61332010 61338025 61353225 61358628 61338029 61358630 61358666 61371216 61370312 61370393 61363474 61363484 61314868 61391745 61471261 61471280 61477302 61550757 7891217 61889853 63246520

Orthopedic Devices

2

Yes

Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON DELIVERY SERVICE (LYNBROOK NY) MALAYSIA MEXICO MIAMI FL MOROCCO NETHERLANDS NEW ZEALAND NICARAGUA PANAMA PERU PHARR TEXAS POLAND PUERTO RICO RIO DE JANEIRO SAUDI ARABIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND THE NETHERLANDS TRIPOLI UK VIRGIN ISLANDS VA/DOD: Both see addresses below

Z NAIL PF 14MM X 46CM UNIV || Z NAIL GT 14MM X 46CM R || Z NAIL GT 14MM X 46CM L || Z NAIL TIBIA 14MM X 38CM UNIV || Z NAIL TIBIA 14MM X 40CM UNIV || Z NAIL TIBIA 14MM X 42CM UNIV || Z NAIL TIBIA 14MM X 44CM UNIV

Catalog Number 97-9990-002-00 Revision 2, 2008. All lots for all devices

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschbach, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Jordan, Israel, Korea, Lebanon, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, S. Africa, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, and Venezuela,

ZMR Porous Revision Hip Prosthesis Surgical Technique, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. || Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.

Catalog Number 87-6203-884-01, Revision H, August 2009 and 87-6203-884-22, July 2010. All lots for all devices

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschbach, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Jordan, Israel, Korea, Lebanon, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, S. Africa, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, and Venezuela,

Zimmer ZMR Hip System Instructions for Use, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. || Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.

Catalog Number 97-9990-007-00 Revision 1, 2010. All lots for all devices

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschbach, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Jordan, Israel, Korea, Lebanon, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, S. Africa, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, and Venezuela,

ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. || Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.

Catalog Number 97-9990-006-00 Revision 1, 2010. All lots for all devices

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Dubai/UAE, Eschbach, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Jordan, Israel, Korea, Lebanon, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Russia, S. Africa, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, UK, Ukraine, and Venezuela,

ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper Stem and Bodies, Calcar Bodies, and Spout Bodies. || Product Usage: The ZMR Hip Prosthesis is indicated for cementless total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.

61841123

Orthopedic Devices

2

Yes

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.

ZIMTRON 6 DEG 22 HEADS

Lot 60465195.

Orthopedic Devices

2

Yes

Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, cone body, size C, 55 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9993-19-55 (Cat. no. 00999301955).

Lot 60454259.

Orthopedic Devices

2

Yes

Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-35 (Cat. no. 00999601935).

Lot 60451050.

Orthopedic Devices

2

Yes

Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 45 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-45 (Cat. no. 00999601945).

Lot 60460936.

Orthopedic Devices

2

Yes

Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size F, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-23-35 (Cat. no. 00999602335).

Lot 60465192.

Orthopedic Devices

2

Yes

Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46 (Cat. no. 00999002046).

Lots 60454205, 60454206 and 60465024.

Orthopedic Devices

2

Yes

Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 17, 150 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-17-04 (00786101704).

Lot 60460460.

Orthopedic Devices

2

Yes

Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V alloy, sterile, w/calcicoat ceramic coating; Cat. no. 65-7861-14-04 (65786101404).

Lots 60454196, 60454197, 60454198, 60454199, 60465016 and 60465017.

Orthopedic Devices

2

Yes

Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-14-04 (00786101404).

Lots 60454201, 60454202, 60454203, 60454204, 60465019 and 60469053.

Orthopedic Devices

2

Yes

Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 15, 140 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-15-04 (00786101504).

61173335 61173337 61173339 61173340 61173341 61115956 61173344 61173346 61173347 61173349 61173350 61173352 61173353 61173354 61173355 61173356 61173357 61173358 61173359 61173360 61173361 61173362 61173363 61173364 61173365 61173366 61359816

Orthopedic Devices

2

Yes

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.

2.7 X 6 CORT SCREW/SELFTA || 2.7 X 7 CORT SCREW/SELFTA || 2.7 X 8 CORT SCREW/SELFTA || 2.7 X 9 CORT SCREW/SELFTA || 2.7 X 10 CORT SCREW/SELFT || 2.7 X 12 CORT SCREW/SELFT || 2.7 X 14 CORT SCREW/SELFT || 2.7 X 16 CORT SCREW/SELFT || 2.7 X 18 CORT SCREW/SELFT || 2.7 X 20 CORT SCREW/SELFT || 2.7 X 22 CORT SCREW/SELFT || 2.7 X 24 CORT SCREW/SELFT || 2.7 X 26 CORT SCREW/SELFT || 2.7 X 28 CORT SCREW/SELFT || 2.7 X 30 CORT SCREW/SELFT || 2.7 X 32 CORT SCREW/SELFT || 2.7 X 34 CORT SCREW/SELFT || 2.7 X 36 CORT SCREW/SELFT || 2.7 X 38 CORT SCREW/SELFT || 2.7 X 40 CORT SCREW/SELFT || 2.7 X 42 CORT SCREW/SELFT || 2.7 X 44 CORT SCREW/SELFT || 2.7 X 45 CORT SCREW/SELFT || 2.7 X 46 CORT SCREW/SELFT || 2.7 X 48 CORT SCREW/SELFT || 2.7 X 50 CORT SCREW/SELFT || 4.0 X 20 CANC SCREW/SELFT

61173204 61173205 61173206 61804309 61173207 61804310 61173208 61117130 61173210 61173212 61173213 61173214 61173215 61173216 61173218 61173219 61173220 61173221 61173223 61173224 61173226 61173228 61173231

Orthopedic Devices

2

Yes

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.

3.5 X 10 CORT SCREW SELFT || 3.5 X 12 CORT SCREW SELFT || 3.5 X 14 CORT SCREW SELFT || 3.5 X 16 CORT SCREW SELFT || 3.5 X 18 CORT SCREW SELFT || 3.5 X 20 CORT SCREW SELFT || 3.5 X 22 CORT SCREW SELFT || 3.5 X 24 CORT SCREW SELFT || 3.5 X 26 CORT SCREW SELFT || 3.5 X 28 CORT SCREW SELFT || 3.5 X 30 CORT SCREW SELFT || 3.5 X 32 CORT SCREW SELFT || 3.5 X 34 CORT SCREW SELFT || 3.5 X 36 CORT SCREW SELFT || 3.5 X 38 CORT SCREW SELFT || 3.5 X 40 CORT SCREW SELFT || 3.5 X 45 CORT SCREW SELFT || 3.5 X 50 CORT SCREW SELFT || 3.5 X 55 CORT SCREW SELFT || 3.5 X 60 CORT SCREW SELFT || 3.5 X 75 CORT SCREW SELFT

Lot Number: 26208600; exp. 2013-02.

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (Arizona, California, Delaware, Indiana, Iowa, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin), Australia, Canada, Germany, Italy, and Spain.

Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.

REF 6200-056-22, lot 62010615

Orthopedic Devices

2

Yes

Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK

The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile || The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.

Catalog Number 00-4310-008/014-17  All lot numbers.

Orthopedic Devices

2

Yes

Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand.

ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer¿ Trabecular Metal Humeral and/or Zimmer¿ Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4310-008/014-17. || The distal pilot manual surgical instrument is used in the surgical procedure to implant the Zimmer¿ Trabecular Metal Humeral and Zimmer¿ Trabecular Metal Reverse Shoulder Systems. The distal pilot is attached to the proximal reamer during proximal reaming and to the proximal provisional during trialing. In both of these cases the distal pilot is used to provide alignment for the proximal devices. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

Catalog Number 00-4310-008/018-13  All Lot Numbers

Orthopedic Devices

2

Yes

Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand.

ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer¿ Trabecular Metal Humeral and/or Zimmer¿ Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4310-008/018-13. || The distal pilot manual surgical instrument is used in the surgical procedure to implant the Zimmer¿ Trabecular Metal Humeral and Zimmer¿ Trabecular Metal Reverse Shoulder Systems. The distal pilot is attached to the proximal reamer during proximal reaming and to the proximal provisional during trialing. In both of these cases the distal pilot is used to provide alignment for the proximal devices. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrained (resurfacing) shoulder prostheses for total or hemi-arthroplasty applications. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. These two systems are used for: - the treatment of severe pain or significant disability in degenerative, - rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

Lot 61159758.

Orthopedic Devices

2

Yes

Nationwide.

Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13. || Shoulder replacement surgery.

Lot 60947164.

Orthopedic Devices

2

Yes

Nationwide.

Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. || Shoulder replacement surgery.

Surgical Technique, Catalog Number: 97-4309-003-00, Rev. 4.

Orthopedic Devices

2

Yes

Worldwide Distribution - USA, Nationwide, Switzerland and Eschbach, Germany, Switzerland, Australia, China, India, Japan, Korea, Malaysia, Singapore, Taiwan, Brazil, Venezuela, El Salvador, Colombia, Canada, and Thailand.

Zimmer¿ Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4. || The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with severe rotator cuff (RC) deficiency. The stem was designed so that its bearing surfaces, as compared to a traditional humeral stem, is such that the humeral component contains a concave ultra-high molecular weight polyethylene (UHMWPE) liner that articulates with a hemispheric metallic glenoid component. System is used for: -the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.