Prelude PF
21 catalogue numbers from 110018155, listed by Biomet Sports Medicine, United States, under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer. 7 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | Biomet Sports Medicine, United States |
|---|---|
| FDA product code | KRR |
| Device type | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3540 |
| 510(k) | K143543 |
| Record published | 2015-11-03 |
| Record revised | 2025-06-25 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110018155 | 34 MM 7.8 MM | In distribution |
| 110005120 | 31 MM 8 MM | In distribution |
| 110018152 | 37 MM 8.5 MM | In distribution |
| 110005116 | 25 MM 8 MM | In distribution |
| 110004335 | 31 MM 6.2 MM | In distribution |
| 110004330 | 25 MM 8 MM | In distribution |
| 110018156 | 37 MM 8.5 MM | In distribution |
| 110018153 | 34 MM 8.5 MM | In distribution |
| 110005117 | 28 MM 6.2 MM | In distribution |
| 110018149 | 37 MM 10 MM | In distribution |
| 110004334 | 28 MM 6.2 MM | In distribution |
| 110018154 | 40 MM 10 MM | In distribution |
| 110018164 | 37 MM 10 MM | In distribution |
| 110005119 | 31 MM 6.2 MM | In distribution |
| 110004333 | 25 MM 6.2 MM | In distribution |
| 110004331 | 28 MM 8 MM | In distribution |
| 110005115 | 25 MM 6.2 MM | In distribution |
| 110018151 | 34 MM 7.8 MM | In distribution |
| 110004332 | 31 MM 8 MM | In distribution |
| 110018148 | 34 MM 8.5 MM | In distribution |
| 110005118 | 28 MM 8 MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 103 |
| Restoris | Mako Surgical Corp. | 76 |
| Prelude Patello-Femoral System | Biomet Orthopedics | 61 |
| Prelude PF | Biomet Orthopedics | 59 |
| KneeTec PFJ | Corin Limited | 49 |
| HemiCAP® | Arthrosurface, Inc. | 48 |
| Instrument | Howmedica Osteonics Corp | 48 |
| Triathlon | Howmedica Osteonics Corp | 23 |
| WaveKahuna™ | Arthrosurface, Inc. | 16 |
| HemiCAPWAVE® | Arthrosurface, Inc. | 16 |
| Sigma | Depuy (Ireland) | 16 |
| Restoris Esyntial | Mako Surgical Corp. | 14 |
Showing 12 of 47. All products under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2016-03-09 | Class II | Device Design | Inadequate design control. | 576 | 2017-05-23 |
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.