OSS™ Orthopedic Salvage System
Catalogue number 151871, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| 510(k) | K002757 |
| Record published | 2018-11-13 |
| Record revised | 2025-05-30 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 151871 | Ø14 mm 30 cm Arcos®/OSS Tapers With Screws | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080528 | 2008-06-17 |
| K022586 | 2002-08-15 |
Recalls Naming This Product
14 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 | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 12 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2018-10-10 | Class II | Under Investigation by firm | Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as th | 3 total | 2020-04-28 |
| Biomet, Inc. | 510(k) number | 2017-06-05 | Class II | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 2018-03-06 | |
| Biomet, Inc. | 510(k) number | 2011-11-01 | Not classified | Mixed-up of materials/components | Biomet has initiated this action following an investigation which identified that Part 150367, (OSS Cemented 1M Stem 13×150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem 14×150). | 3 units & 1 pending release | 2012-09-10 |
| 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 |
| Biomet, Inc. | 510(k) number | 2008-05-15 | Not classified | Labeling False and Misleading | Mislabeled–The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package co | 14 for all products. | 2008-11-03 |
| Biomet, Inc. | 510(k) number | 2008-05-15 | Not classified | Labeling False and Misleading | Mislabeled–The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package co | 14 for all products. | 2008-11-03 |
| Biomet, Inc. | 510(k) number | 2008-05-15 | Not classified | Labeling False and Misleading | Mislabeled–The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package co | 14 for all products. | 2008-11-03 |
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.