Product code KWA
- Device name
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Medical specialty
- Orthopedic
- Device class
- 3
- Regulation number
- 888.3330
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122778 | PROFEMUR Z REVISION HIP STEM | Wrightmedicaltechnologyinc | 2012-10-11 |
| K121544 | DYNASTY BIOFOAM SHELL | Wrightmedicaltechnologyinc | 2012-07-30 |
| K113271 | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS | Biomet Manufacturing, Inc. | 2012-05-18 |
| K113322 | CONSERVE THIN SHELL | Wrightmedicaltechnologyinc | 2012-02-03 |
| K112080 | PRESERVE HIP STEM | Wrightmedicaltechnologyinc | 2011-12-28 |
| K112150 | PROFEMUR GLADIATOR HA HIP STEM | Wrightmedicaltechnologyinc | 2011-11-23 |
| K113019 | PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER | Wrightmedicaltechnologyinc | 2011-11-10 |
| K111910 | GLADIATOR HIP STEM | Wrightmedicaltechnologyinc | 2011-10-14 |
| K110836 | CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY | Zimmer GmbH | 2011-10-07 |
| K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | Biomet Manufacturing Corp | 2011-09-30 |
| K111699 | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM | Wrightmedicaltechnologyinc | 2011-08-19 |
| K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM | Wrightmedicaltechnologyinc | 2011-08-19 |
| K110399 | GLADIATOR PLASMA CLASSIC HIP STEM | Wrightmedicaltechnologyinc | 2011-05-10 |
| K110029 | CONSERVE BIO FOAM SHELL | Wrightmedicaltechnologyinc | 2011-04-19 |
| K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | Biomet Manufacturing Corp | 2011-01-21 |
| K102565 | ANTERIOR APPROACH HIP SURGERY INSTRUMENTS | Wrightmedicaltechnologyinc | 2010-12-22 |
| K100469 | ARCOS INTERLOCKING DISTAL STEMS | Biomet Manufacturing Corp | 2010-12-07 |
| K101086 | TAPERLOC COMPLETE | Biomet, Inc. | 2010-09-03 |
| K101475 | COMPRESS ANTI-ROTATION SPINDLES | Biomet Manufacturing Corp | 2010-06-18 |
| K093235 | RINGLOC + HYBRID ACETABULAR SYSTEM | Biomet, Inc. | 2010-04-30 |
| K092331 | DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; | Encore Medical L.P. | 2010-03-03 |
| K091003 | ZIMMER MMC CUP | Zimmer GmbH | 2009-11-24 |
| K091973 | METASUL TAPER LINERS, METASUL FEMORAL HEADS | Zimmer GmbH | 2009-11-17 |
| K090757 | BIOMET MODULAR FEMORAL REVISION SYSTEM | Biomet, Inc. | 2009-09-25 |
| K091423 | PROFEMUR HIP SYSTEM MODULAR NECKS | Wrightmedicaltechnologyinc | 2009-08-25 |
| K083651 | REVELATION STEM, MODEL 427-21/42-080/180 | Encore Medical L.P. | 2009-03-13 |
| K082924 | DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER | Wrightmedicaltechnologyinc | 2009-03-06 |
| K083642 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | 2009-03-06 |
| K082585 | DEPUY ASPHERE M-SPEC HEAD | DePuy Orthopaedics, Inc. | 2008-12-04 |
| K082446 | BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS | Biomet, Inc. | 2008-10-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10603295033653 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295178255 | S-ROM | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033929 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295033905 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295033844 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033837 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033806 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295033769 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295033721 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033714 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033707 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033691 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033684 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033677 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033660 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295015840 | S-ROM MARATHON | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033554 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295033516 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295033479 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033462 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033394 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295033370 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295033332 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033325 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033318 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295033011 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295032953 | ASPHERE | DEPUY (IRELAND) | 2015-03-24 |
| 10603295015918 | S-ROM MARATHON | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295015901 | S-ROM MARATHON | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295015857 | S-ROM MARATHON | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |