Oxford Fixed Lateral
60 catalogue numbers from 32-423382, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
60catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HRY |
| Device type | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3530 |
| 510(k) | K133940 |
| Record published | 2016-10-21 |
| Record revised | 2025-05-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-423382 | E3 RIGHT | In distribution |
| 32-423379 | D5 RIGHT | In distribution |
| 32-423006 | B3 LEFT | In distribution |
| 32-423364 | A5 RIGHT | In distribution |
| 32-423005 | A7 LEFT | In distribution |
| 32-423363 | A4 RIGHT | In distribution |
| 32-423370 | B6 RIGHT | In distribution |
| 32-423002 | A4 LEFT | In distribution |
| 32-423024 | E6 LEFT | In distribution |
| 32-423028 | F5 LEFT | In distribution |
| 32-423009 | B6 LEFT | In distribution |
| 32-423012 | C4 LEFT | In distribution |
| 32-423376 | C7 RIGHT | In distribution |
| 32-423387 | F3 RIGHT | In distribution |
| 32-423030 | F7 LEFT | In distribution |
| 32-423021 | E3 LEFT | In distribution |
| 32-423019 | D6 LEFT | In distribution |
| 32-423383 | E4 RIGHT | In distribution |
| 32-423365 | A6 RIGHT | In distribution |
| 32-423015 | C7 LEFT | In distribution |
| 32-423018 | D5 LEFT | In distribution |
| 32-423001 | A3 LEFT | In distribution |
| 32-423014 | C6 LEFT | In distribution |
| 32-423017 | D4 LEFT | In distribution |
| 32-423025 | E7 LEFT | In distribution |
| 32-423373 | C4 RIGHT | In distribution |
| 32-423007 | B4 LEFT | In distribution |
| 32-423391 | F7 RIGHT | In distribution |
| 32-423026 | F3 LEFT | In distribution |
| 32-423377 | D3 RIGHT | In distribution |
| 32-423375 | C6 RIGHT | In distribution |
| 32-423020 | D7 LEFT | In distribution |
| 32-423366 | A7 RIGHT | In distribution |
| 32-423385 | E6 RIGHT | In distribution |
| 32-423371 | B7 RIGHT | In distribution |
| 32-423368 | B4 RIGHT | In distribution |
| 32-423023 | E5 LEFT | In distribution |
| 32-423008 | B5 LEFT | In distribution |
| 32-423011 | C3 LEFT | In distribution |
| 32-423386 | E7 RIGHT | In distribution |
| 32-423022 | E4 LEFT | In distribution |
| 32-423013 | C5 LEFT | In distribution |
| 32-423388 | F4 RIGHT | In distribution |
| 32-423372 | C3 RIGHT | In distribution |
| 32-423384 | E5 RIGHT | In distribution |
| 32-423027 | F4 LEFT | In distribution |
| 32-423374 | C5 RIGHT | In distribution |
| 32-423029 | F6 LEFT | In distribution |
| 32-423380 | D6 RIGHT | In distribution |
| 32-423362 | A3 RIGHT | In distribution |
| 32-423004 | A6 LEFT | In distribution |
| 32-423003 | A5 LEFT | In distribution |
| 32-423378 | D4 RIGHT | In distribution |
| 32-423381 | D7 RIGHT | In distribution |
| 32-423369 | B5 RIGHT | In distribution |
| 32-423389 | F5 RIGHT | In distribution |
| 32-423016 | D3 LEFT | In distribution |
| 32-423390 | F6 RIGHT | In distribution |
| 32-423367 | B3 RIGHT | In distribution |
| 32-423010 | B7 LEFT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Legion | Smith & Nephew, Inc. | 1,682 |
| Genesis II | Smith & Nephew, Inc. | 615 |
| Journey II | Smith & Nephew, Inc. | 581 |
| Evolution | Microport Orthopedics Inc. | 311 |
| Profix | Smith & Nephew, Inc. | 293 |
| Journey | Smith & Nephew, Inc. | 215 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 201 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Smith & Nephew, Inc. | 160 |
| JII | Smith & Nephew, Inc. | 141 |
| Physica KR | Limacorporate | 128 |
| Physica LMC | Limacorporate | 120 |
| Implant Partners | Microport Orthopedics Inc. | 119 |
Showing 12 of 160. All products under Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020264 | 2002-02-08 |
Recalls Naming This Product
4 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 | 2022-12-15 | Class II | Package design/selection | Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the steril | 7 units | |
| 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 | 76 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2016-12-06 | Class II | Employee error | Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right was opened it actually contained a Left | 12 units distributed | 2017-06-01 |
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 |
|---|---|---|---|
| P840049 | 1988-09-30 | P.C.A.(TM) TOTAL KNEE SYSTEM | Howmedica Corp. |
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.