PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
FDA 510(k) clearance K123907 · decided 2013-09-03
Clearance details
- K-number
- K123907
- Device name
- PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2012-12-19
- Decision date
- 2013-09-03
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- KRR
- Device class
- 2
- Regulation number
- 888.3540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Overture Orthopaedics Patellofemoral System (K231253) | Overture Resurfacing, Inc. | 2023-07-07 |
| Episealer Patellofemoral System (K221048) | Episurf Medical, Inc. | 2022-12-23 |
| Avon Patello-femoral Joint Prosthesis (K211303) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021-06-04 |
| MOTO PFJ System (K200122) | Medacta International S.A. | 2020-04-20 |
| Patello-Femoral Wave (Kahuna) Arthroplasty System (K181280) | Arthrosurface, Inc. | 2018-06-14 |
| Arthrex iBalance BiCompartmental Arthroplasty System (K160461) | Arthrex, Inc. | 2016-04-12 |
| Prelude PF Patellae (K143543) | Biomet, Inc. | 2015-01-30 |
| KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT (K111970) | Tornier | 2012-02-23 |
| MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II (K082088) | Mako Surgical Corp. | 2008-10-22 |
| MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM (K080029) | Mako Surgical Corp. | 2008-05-16 |
| ACCIN PATELLOFEMORAL SYSTEM (K073120) | Accelerated Innovation, LLC | 2008-02-29 |
| HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM (K071413) | Arthrosurface, Inc. | 2007-11-09 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| All instrumentation associated with the Prelude PF Resurfacing Knee System. recall (Z-1318-2016) | Biomet, Inc. | 2016-04-04 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Oxford Partial Knee System (P010014/S117) | Biomet Manufacturing Corp | 2026-07-13 |
| Oxford Partial Knee System; Cementless OxfordPartial Knee System (P010014/S112) | Biomet Manufacturing Corp | 2026-05-27 |
| Oxford® Partial Knee System (P010014/S116) | Biomet Manufacturing Corp | 2026-05-12 |
| Oxford® Partial Knee System (P010014/S115) | Biomet Manufacturing Corp | 2026-04-20 |
| Oxford Cementless Partial Knee System (P010014/S114) | Biomet Manufacturing Corp | 2026-03-06 |
| Oxford Partial Knee System (P010014/S113) | Biomet Manufacturing Corp | 2026-01-16 |
| Oxford Knee System (P010014/S111) | Biomet Manufacturing Corp | 2025-08-07 |
| Oxford Partial Knee System (P010014/S109) | Biomet Manufacturing Corp | 2025-08-07 |