Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer
69 catalogue numbers from 802804004, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
69catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (2), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KWZ |
| Device type | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3310 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K181171 |
| Record published | 2019-09-27 |
| Record revised | 2020-12-21 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2017-05-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 802804004 | Type 1 Taper, +6 mm Neck Length | In distribution |
| 802604402 | 12/14 Taper, +0 mm Neck Length | In distribution |
| 802503606 | 36 mm Diameter, +9 mm Neck Length | In distribution |
| 802304005 | 40 mm Diameter, +10.5 mm Neck Length | In distribution |
| 9375-28-077 | 28mm X 77mm | In distribution |
| 9375-28-073 | 28mm X 73mm | In distribution |
| 9375-28-065 | 28mm X 65mm | In distribution |
| 802202804 | 12/14 Taper, 28 mm Diameter, +7 mm, Neck Length | In distribution |
| 802802203 | Type 1 Taper, +3 mm Neck Length | In distribution |
| 802602203 | 12/14 Taper, +3 mm Neck Length | In distribution |
| 9375-38-061 | 38mm X 61mm | In distribution |
| 802804401 | Type 1 Taper, -3 mm Neck Length | In distribution |
| 802603202 | 12/14 Taper, +0 mm Neck Length | In distribution |
| 802804402 | Type 1 Taper, +0 mm Neck Length | In distribution |
| 802803603 | Type 1 Taper, +3 mm Neck Length | In distribution |
| 802803201 | Type 1 Taper, -3 mm Neck Length | In distribution |
| 802503603 | 36 mm Diameter, +0 mm Neck Length | In distribution |
| 9375-28-075 | 28mm X 75mm | In distribution |
| 802304403 | 44 mm Diameter, +3.5 mm Neck Length | In distribution |
| 802202202 | 12/14 Taper, 22.2 mm Diameter, +0 mm, Neck Length | In distribution |
| 802603601 | 12/14 Taper, -3.5 mm Neck Length | In distribution |
| 802602202 | 12/14 Taper, +0 mm Neck Length | In distribution |
| 802203601 | 12/14 Taper, 36 mm Diameter, -3.5 mm, Neck Length | In distribution |
| 802204405 | 12/14 Taper, 44 mm Diameter, +10.5 mm, Neck Length | In distribution |
| 9375-38-071 | 38mm X 71mm | In distribution |
| 802304405 | 44 mm Diameter, +10.5 mm Neck Length | In distribution |
| 9375-38-067 | 38mm X 67mm | In distribution |
| 802803604 | Type 1 Taper, +6 mm Neck Length | In distribution |
| 802603201 | 12/14 Taper, -3.5 mm Neck Length | In distribution |
| 802203603 | 12/14 Taper, 36 mm Diameter, +3.5 mm, Neck Length | In distribution |
| 802804403 | Type 1 Taper, +3 mm Neck Length | In distribution |
| 9375-28-063 | 28mm X 63mm | In distribution |
| 9375-28-057 | 28mm X 57mm | In distribution |
| 9375-28-055 | 28mm X 55mm | In distribution |
| 9375-38-065 | 38mm X 65mm | In distribution |
| 802603603 | 12/14 Taper, +3.5 mm Neck Length | In distribution |
| 802802203 | Type 1 Taper, +3 mm Neck Length | In distribution |
| 9375-28-059 | 28mm X 59mm | In distribution |
| 802804404 | Type 1 Taper, +6 mm Neck Length | In distribution |
| 9375-28-069 | 28mm X 69mm | In distribution |
| 802303605 | 36 mm Diameter, +10.5 mm Neck Length | In distribution |
| 802603204 | 12/14 Taper, +7 mm Neck Length | In distribution |
| 9375-28-061 | 28mm X 61mm | In distribution |
| 802202203 | 12/14 Taper, 22.2 mm Diameter, +3 mm, Neck Length | In distribution |
| 9375-28-071 | 28mm X 71mm | In distribution |
| 9375-38-063 | 38mm X 63mm | In distribution |
| 9375-28-051 | 28mm X 51mm | In distribution |
| 802503201 | 32 mm Diameter, -3 mm Neck Length | In distribution |
| 802602802 | 12/14 Taper, +0 mm Neck Length | In distribution |
| 9375-28-053 | 28mm X 53mm | In distribution |
| 802604404 | 12/14 Taper, +7 mm Neck Length | In distribution |
| 802302201 | 22.2 mm Diameter, -2 mm Neck Length | In distribution |
| 9375-32-057 | 32mm X 57mm | In distribution |
| 9375-32-059 | 32mm X 59mm | In distribution |
| 9375-32-055 | 32mm X 55mm | In distribution |
| 9375-28-067 | 28mm X 67mm | In distribution |
| 802202201 | 12/14 Taper, 22.2 mm Diameter, -2 mm, Neck Length | In distribution |
| 802204001 | 12/14 Taper, 40 mm Diameter, -3.5 mm, Neck Length | In distribution |
| 802604403 | 12/14 Taper, +3.5 mm Neck Length | In distribution |
| 9375-38-069 | 38mm X 69mm | In distribution |
| 802803202 | Type 1 Taper, +0 mm Neck Length | In distribution |
| 802803602 | Type 1 Taper, +0 mm Neck Length | In distribution |
| 802802802 | Type 1 Taper, +0 mm Neck Length | In distribution |
| 9377-00-038 | 38mm | Withdrawn |
| 9376-00-028 | 28mm | Withdrawn |
| 9377-00-028 | 28mm | Withdrawn |
| 9377-00-032 | 32mm | Withdrawn |
| 9376-00-038 | 38mm | Withdrawn |
| 9376-00-032 | 32mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 159 |
| Instrument | Howmedica Osteonics Corp | 139 |
| ZMR® | Zimmer, Inc. | 103 |
| Arcos Modular Revision System | Biomet Orthopedics | 66 |
| Pinnacle | Depuy Orthopaedics, Inc. | 52 |
| System 12 | Howmedica Osteonics Corp | 47 |
| Restoration | Howmedica Osteonics Corp | 46 |
| Redapt | Smith & Nephew, Inc. | 43 |
| R3 | Smith & Nephew, Inc. | 41 |
| Trident | Howmedica Osteonics Corp | 38 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 37 |
| G7® | Biomet Orthopedics | 37 |
Showing 12 of 165. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101730 | 2010-12-03 |
| K072121 | 2008-01-07 |
| K071718 | 2007-07-13 |
| K021826 | 2002-12-20 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 416 units |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 215 units |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 167 units |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 158 units |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 160 units |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-08-27 | Class II | Labeling Change Control | Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton. | 1 | 2013-08-27 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P960054 | 1997-06-19 | S-ROM POLY-DIAL CONSTRAINED LINER | Depuy, A Johnson & Johnson Co. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.