KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Class III
FDA product code KWA covers "Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)", a Class III medical device regulated under 21 CFR 888.3330. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KWA
- Device Class
- Class III
- Regulation Number
- 888.3330
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K122778 | wrightmedicaltechnologyinc | PROFEMUR Z REVISION HIP STEM | October 11, 2012 |
| K121544 | wrightmedicaltechnologyinc | DYNASTY BIOFOAM SHELL | July 30, 2012 |
| K113271 | biomet manufacturing | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS | May 18, 2012 |
| K113322 | wrightmedicaltechnologyinc | CONSERVE THIN SHELL | February 3, 2012 |
| K112080 | wrightmedicaltechnologyinc | PRESERVE HIP STEM | December 28, 2011 |
| K112150 | wrightmedicaltechnologyinc | PROFEMUR GLADIATOR HA HIP STEM | November 23, 2011 |
| K113019 | wrightmedicaltechnologyinc | PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER | November 10, 2011 |
| K111910 | wrightmedicaltechnologyinc | GLADIATOR HIP STEM | October 14, 2011 |
| K110836 | zimmer | CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY | October 7, 2011 |
| K110400 | biomet manufacturing | TAPERLOC COMPLETE MICROPLASTY STEM | September 30, 2011 |
| K111698 | wrightmedicaltechnologyinc | PROFEMUR(R) E CEMENTLESS HIP STEM | August 19, 2011 |
| K111699 | wrightmedicaltechnologyinc | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM | August 19, 2011 |
| K110399 | wrightmedicaltechnologyinc | GLADIATOR PLASMA CLASSIC HIP STEM | May 10, 2011 |
| K110029 | wrightmedicaltechnologyinc | CONSERVE BIO FOAM SHELL | April 19, 2011 |
| K103755 | biomet manufacturing | TAPERLOC COMPLETE, SIZE 5 AND 6 | January 21, 2011 |
| K102565 | wrightmedicaltechnologyinc | ANTERIOR APPROACH HIP SURGERY INSTRUMENTS | December 22, 2010 |
| K100469 | biomet manufacturing | ARCOS INTERLOCKING DISTAL STEMS | December 7, 2010 |
| K101086 | biomet | TAPERLOC COMPLETE | September 3, 2010 |
| K101475 | biomet manufacturing | COMPRESS ANTI-ROTATION SPINDLES | June 18, 2010 |
| K093235 | biomet | RINGLOC + HYBRID ACETABULAR SYSTEM | April 30, 2010 |