M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
FDA 510(k) clearance K061423 · decided 2006-07-27
Clearance details
- K-number
- K061423
- Device name
- M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2006-05-23
- Decision date
- 2006-07-27
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- KWA
- Device class
- 3
- Regulation number
- 888.3330
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| PROFEMUR Z REVISION HIP STEM (K122778) | Wrightmedicaltechnologyinc | 2012-10-11 |
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| CONSERVE THIN SHELL (K113322) | Wrightmedicaltechnologyinc | 2012-02-03 |
| PRESERVE HIP STEM (K112080) | Wrightmedicaltechnologyinc | 2011-12-28 |
| PROFEMUR GLADIATOR HA HIP STEM (K112150) | Wrightmedicaltechnologyinc | 2011-11-23 |
| PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (K113019) | Wrightmedicaltechnologyinc | 2011-11-10 |
| GLADIATOR HIP STEM (K111910) | Wrightmedicaltechnologyinc | 2011-10-14 |
| CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (K110836) | Zimmer GmbH | 2011-10-07 |
| TAPERLOC COMPLETE MICROPLASTY STEM (K110400) | Biomet Manufacturing Corp | 2011-09-30 |
| PROFEMUR(R) E CEMENTLESS HIP STEM (K111698) | Wrightmedicaltechnologyinc | 2011-08-19 |
| PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699) | Wrightmedicaltechnologyinc | 2011-08-19 |
Recalls involving this device
No recalls on record reference this clearance.
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 |