M2A/C2A ACETABULAR SYSTEM
FDA 510(k) clearance K042841 · decided 2004-12-21
Clearance details
- K-number
- K042841
- Device name
- M2A/C2A ACETABULAR SYSTEM
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-10-14
- Decision date
- 2004-12-21
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JDL
- Device class
- 3
- Regulation number
- 888.3320
- 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 |
|---|---|---|
| VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (K073499) | Zimmer, Inc. | 2008-08-07 |
| DYNASTY ACETABULAR SYSTEM (K070785) | Wrightmedicaltechnologyinc | 2007-07-11 |
| DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (K061844) | Wrightmedicaltechnologyinc | 2006-12-06 |
| PROFEMUR RENAISSANCE HIP STEM (K051995) | Wrightmedicaltechnologyinc | 2005-08-22 |
| CONSERVE TOTAL FEMORAL HEAD (K051348) | Wrightmedicaltechnologyinc | 2005-08-19 |
| PROFEMUR S HIP STEM (K041586) | Wrightmedicaltechnologyinc | 2004-07-09 |
| PROFEMUR TAPERED HIP STEM (K041114) | Wrightmedicaltechnologyinc | 2004-05-28 |
| METAL TRANSCEND ARTICULATION SYSTEM (K004043) | Wrightmedicaltechnologyinc | 2001-07-13 |
| METAL BACKED ACETABULAR COMPONENT (K950542) | Encore Orthopedics, Inc. | 1995-05-25 |
| P.F.C. APICAL PLUG (K944769) | Johnson & Johnson Professionals, Inc. | 1994-12-08 |
| ACETABULAR DOME HOLE PLUGS (K942809) | Osteonics Corp. | 1994-09-20 |
| S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG (K931676) | Joint Medical Products Corp. | 1994-05-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |