Prelude Patello-Femoral System
61 catalogue numbers from 110004106, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
61catalogue numbers in this listing
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 Orthopedics, 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 | 2016-10-28 |
| 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 |
|---|---|---|
| 110004106 | NO. 1 DRILL GUIDE, RIGHT | In distribution |
| 110004165 | 31MM STOP COLLAR | In distribution |
| 010001738 | NO. 7W LEFT KNEE TRIAL | In distribution |
| 010001712 | NO. 2 RIGHT KNEE TRIAL | In distribution |
| 110004117 | NO. 6W DRILL GUIDE, LEFT | In distribution |
| 110004262 | NO. 7W FEMORAL TRIAL, RIGHT | In distribution |
| 010001734 | NO. 6W LEFT KNEE TRIAL | In distribution |
| 110004254 | NO. 4 FEMORAL TRIAL, RIGHT | In distribution |
| 110004111 | NO. 4 DRILL GUIDE, LEFT | In distribution |
| 110004256 | NO. 5 FEMORAL TRIAL, RIGHT | In distribution |
| 110018820 | 25MM PEEK BUSHING | In distribution |
| 110004258 | NO. 6 FEMORAL TRIAL, RIGHT | In distribution |
| 110004248 | NO. 1 FEMORAL TRIAL, RIGHT | In distribution |
| 110004250 | NO. 2 FEMORAL TRIAL, RIGHT | In distribution |
| 110004120 | NO. 7W DRILL GUIDE, RIGHT | In distribution |
| 010001718 | NO. 4 LEFT KNEE TRIAL | In distribution |
| 010001708 | NO. 1 RIGHT KNEE TRIAL | In distribution |
| 110004113 | NO. 5 DRILL GUIDE, LEFT | In distribution |
| 110004119 | NO. 7W DRILL GUIDE, LEFT | In distribution |
| 110004115 | NO. 6 DRILL GUIDE, LEFT | In distribution |
| 110004107 | NO. 2 DRILL GUIDE, LEFT | In distribution |
| 010001768 | 31MM REAMER | In distribution |
| 110004343 | NO. 7W FEMORAL TRIAL, LEFT | In distribution |
| 110004338 | NO. 1 FEMORAL TRIAL, LEFT | In distribution |
| 110004112 | NO. 4 DRILL GUIDE, RIGHT | In distribution |
| 110004344 | NO. 3 FEMORAL TRIAL, LEFT | In distribution |
| 110004109 | NO. 3 DRILL GUIDE, LEFT | In distribution |
| 010001706 | NO. 1 LEFT KNEE TRIAL | In distribution |
| 010001716 | NO. 3 RIGHT KNEE TRIAL | In distribution |
| 110004122 | NO. 8W DRILL GUIDE, RIGHT | In distribution |
| 010001763 | 25MM REAMER | In distribution |
| 110004105 | NO. 1 DRILL GUIDE, LEFT | In distribution |
| 010001732 | NO. 6 RIGHT KNEE TRIAL | In distribution |
| 110004264 | NO. 8W FEMORAL TRIAL, RIGHT | In distribution |
| 110004121 | NO. 8W DRILL GUIDE, LEFT | In distribution |
| 110004339 | NO. 2 FEMORAL TRIAL, LEFT | In distribution |
| 110004108 | NO. 2 DRILL GUIDE, RIGHT | In distribution |
| 110004337 | NO. 6 FEMORAL TRIAL, LEFT | In distribution |
| 010001742 | NO. 8W LEFT KNEE TRIAL | In distribution |
| 110004341 | NO. 5 FEMORAL TRIAL, LEFT | In distribution |
| 110004118 | NO. 6W DRILL GUIDE, RIGHT | In distribution |
| 010001744 | NO. 8W RIGHT KNEE TRIAL | In distribution |
| 010001740 | NO. 7W RIGHT KNEE TRIAL | In distribution |
| 010001720 | NO. 4 RIGHT KNEE TRIAL | In distribution |
| 110004260 | NO. 6W FEMORAL TRIAL, RIGHT | In distribution |
| 010001722 | NO. 5 LEFT KNEE TRIAL | In distribution |
| 110004172 | In distribution | |
| 110004110 | NO. 3 DRILL GUIDE, RIGHT | In distribution |
| 010001710 | NO. 2 LEFT KNEE TRIAL | In distribution |
| 010001730 | NO. 6 LEFT KNEE TRIAL | In distribution |
| 010001724 | NO. 5 RIGHT KNEE TRIAL | In distribution |
| 110004340 | NO. 6W FEMORAL TRIAL, LEFT | In distribution |
| 110004342 | NO. 4 FEMORAL TRIAL, LEFT | In distribution |
| 010001736 | NO. 6W RIGHT KNEE TRIAL | In distribution |
| 110004116 | NO. 6 DRILL GUIDE, RIGHT | In distribution |
| 110004114 | NO. 5 DRILL GUIDE, RIGHT | In distribution |
| 110018821 | 31MM PEEK BUSHING | In distribution |
| 110004252 | NO. 3 FEMORAL TRIAL, RIGHT | In distribution |
| 110004345 | NO. 8W FEMORAL TRIAL, LEFT | In distribution |
| 110004151 | 25MM STOP COLLAR | In distribution |
| 010001714 | NO. 3 LEFT KNEE TRIAL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 103 |
| Restoris | Mako Surgical Corp. | 76 |
| Prelude PF | Biomet Orthopedics | 59 |
| KneeTec PFJ | Corin Limited | 49 |
| HemiCAP® | Arthrosurface, Inc. | 48 |
| Instrument | Howmedica Osteonics Corp | 48 |
| Triathlon | Howmedica Osteonics Corp | 23 |
| Prelude PF | Biomet Sports Medicine | 21 |
| 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.