PCA ACETABULAR INSERT II
FDA 510(k) clearance K921384 · decided 1992-06-25
Clearance details
- K-number
- K921384
- Device name
- PCA ACETABULAR INSERT II
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-23
- Decision date
- 1992-06-25
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- JDL
- Device class
- 3
- Regulation number
- 888.3320
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Rutherford, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Howmedica Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| M2A/C2A ACETABULAR SYSTEM (K042841) | Biomet, Inc. | 2004-12-21 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |