COLLARLESS POLISHED TAPER HIP PROSTHESIS— 510(k) K960658

Clearance details

Applicant

Zimmer, Inc.

Product code

Code JDI

Device class

Class 2

Regulation

21 CFR 888.3350

Advisory panel

Orthopedic

Date received

1996-02-16

Decision date

1996-07-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K260831 — Z1 Hip System2026-06-16
• K261683 — Augment Off-Axis Instrument System2026-06-16
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• K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
• K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)2026-04-13

Death

65

Injury

12,943

Malfunction

1,681

Total

14,689

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2450-2024 — CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400 00811400410 00811400420 00811400423 00811400426 00811400430 00811400500 00811400510 00811400530 00811401218 00811401318 00811404000 00811405000Class II·Ongoing·Zimmer, Inc.·20240702
• Z-1015-2018 — CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncementedClass II·Terminated·Zimmer Biomet, Inc.·20171129
• Z-1016-2018 — CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncementedClass II·Terminated·Zimmer Biomet, Inc.·20171129
• Z-1017-2018 — CPT 12/14 COCR SIZE 1 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncementedClass II·Terminated·Zimmer Biomet, Inc.·20171129
• Z-1018-2018 — CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncementedClass II·Terminated·Zimmer Biomet, Inc.·20171129
• Z-1019-2018 — CPT 12/14 COCR SIZE 2 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncementedClass II·Terminated·Zimmer Biomet, Inc.·20171129
• Z-0844-2016 — CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures."Class II·Terminated·Zimmer Biomet, Inc.·20160111
• Z-1119-2016 — Product 21 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S 811400010 CPT 12/14 COCR SIZE 0 EXT 811400000 CPT 12/14 COCR SIZE 0 STD 811400110 CPT 12/14 COCR SIZE 1 EXT 811400100 CPT 12/14 COCR SIZE 1 STD 811400210 CPT 12/14 COCR SIZE 2 EXT 811400200 CPT 12/14 COCR SIZE 2 STD 811400230 CPT 12/14 COCR SIZE 2 XEX 811400310 CPT 12/14 COCR SIZE 3 EXT 811400300 CPT 12/14 COCR SIZE 3 STD 811400330 CPT 12/14 COCR SIZE 3 XEX 811400410 CPT 12/14 COCR SIZE 4 EXT 811400400 CPT 12/14 COCR SIZE 4 STD 811400430 CPT 12/14 COCR SIZE 4 XEX 811400510 CPT 12/14 COCR SIZE 5 EXT 811400500 CPT 12/14 COCR SIZE 5 STD 811400530 CPT 12/14 COCR SIZE 5 XEX Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.Class II·Terminated·Zimmer Manufacturing B.V.·20160111
• Z-0608-2014 — CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658Class II·Terminated·Zimmer, Inc.·20131210
• Z-0610-2014 — Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.Class II·Terminated·Zimmer, Inc.·20131210
• Z-1032-2014 — CPT 12/14 COCR (various sizes)Class II·Terminated·Zimmer, Inc.·20131011
• Z-1036-2014 — CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)Class II·Terminated·Zimmer, Inc.·20131011
• Z-0069-2014 — CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CPT 12/14 SIZE 4 COCR XEXT; CPT 12/14 STEM SIZE 5 COCR; CPT 12/14 SIZE 5 COCR EXT; CPT 12/14 SIZE 5 COCR XEXT; CPT 12/14 STEM 2-180 VALGUSNCK; CPT 12/14 STEM 3-180 VALGUSNCK; CPT 12/14 STEM X-SML COCR; and CPT 12/14 STEM SML COCR). Indicated for cemented use in patients suffering from severe hip pain.Class II·Terminated·Zimmer, Inc.·20130830
• Z-0062-2013 — CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.Class II·Terminated·Zimmer, Inc.·20120913

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K960658.