Compress® Device
11 catalogue numbers from 178355, listed by Biomet Orthopedics, 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
11catalogue numbers in this listing
1510(k) clearance
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 | Biomet Orthopedics, 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 |
| 510(k) | K031804 |
| Record published | 2015-10-24 |
| Record revised | 2026-03-25 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 178355 | 1 CM 38MM Ø SMALL SIZE | In distribution | |
| 178533 | 56MM LENGTH | 6 | In distribution |
| 178557 | 15 MM | In distribution | |
| 178711 | 5 CM | In distribution | |
| 178538 | 16MM Ø | In distribution | |
| 178574 | 76MM LENGTH | 6 | In distribution |
| 178531 | 48MM LENGTH | 6 | In distribution |
| 178365 | 1 CM 38MM Ø SMALL SIZE | In distribution | |
| 178565 | 23 MM | In distribution | |
| 178567 | 25 MM | In distribution | |
| 178710 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 159 |
| Instrument | Howmedica Osteonics Corp | 139 |
| ZMR® | Zimmer, Inc. | 103 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Zimmer, Inc. | 69 |
| 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 |
Showing 12 of 165. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K021661 | 2002-10-25 |
Recalls Naming This Product
27 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 | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2023-10-09 | Class II | Device Design | Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery | ||
| Biomet, Inc. | 510(k) number | 2019-08-21 | Class II | Environmental control | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 219988 units | 2021-07-21 |
| Biomet, Inc. | 510(k) number | 2018-10-24 | Class II | Employee error | Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted | 6 units | 2020-04-14 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
| Biomet, Inc. | 510(k) number | 2009-05-19 | Not classified | Process control | The retaining ring may fall out of the instrument during surgery. | 387 of all products | 2010-10-08 |
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.