EVOLVE MODULAR RADIAL HEAD
FDA 510(k) clearance K060731 · decided 2006-04-19
Clearance details
- K-number
- K060731
- Device name
- EVOLVE MODULAR RADIAL HEAD
- Applicant
- Wrightmedicaltechnologyinc
- Decision
- Substantially Equivalent
- Date received
- 2006-03-20
- Decision date
- 2006-04-19
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KWI
- Device class
- 2
- Regulation number
- 888.3170
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Arlington, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Wrightmedicaltechnologyinc
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 |
|---|---|---|
| Arthrex Radial Head Replacement System (K260624) | Arthrex, Inc. | 2026-07-30 |
| BioPoly Radial Head Implant (K233592) | BioPoly, LLC | 2024-03-13 |
| ALIGN Radial Head System (K231188) | Skeletal Dynamics, Inc. | 2023-09-28 |
| DePuy Synthes Radial Head Replacement System (K213563) | DePuy Synthes | 2022-03-18 |
| Avenger Radial Head System (K212872) | In2bones USA, LLC | 2021-12-17 |
| Avenger Radial Head System (K192754) | In2bones USA, LLC | 2020-01-07 |
| Revolution Radial Head (K183618) | Ignite Orthopedics, Inc. | 2019-05-17 |
| Align Radial Head System (K172688) | Skeletal Dynamics, LLC | 2017-12-22 |
| AXIA RADIAL HEAD SYSTEM (K132735) | Imds (Innovative MEdical Device Systems) - Leis ME | 2014-01-07 |
| ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC (K131845) | Acumed, LLC | 2013-09-30 |
| SYNTHES RADIAL HEAD PROSTHESIS SYSTEM (K112030) | Synthes USA, LLC | 2012-06-19 |
| ALIGN RADIAL HEAD SYSTEM (K092721) | Skeletal Dynamics, LLC | 2010-08-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proli recall (Z-0005-2023) | Wright Medical Technology, Inc. | 2022-10-04 |
| stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Prol recall (Z-0006-2023) | Wright Medical Technology, Inc. | 2022-10-04 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL (P960057/S011) | Wrightmedicaltechnologyinc | 2000-09-27 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S004) | Wrightmedicaltechnologyinc | 1999-08-11 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S008) | Wrightmedicaltechnologyinc | 1999-06-02 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S006) | Wrightmedicaltechnologyinc | 1999-04-21 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S005) | Wrightmedicaltechnologyinc | 1999-03-18 |
| ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S003) | Wrightmedicaltechnologyinc | 1999-01-14 |
| ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S002) | Wrightmedicaltechnologyinc | 1998-11-25 |
| ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL (P960057/S001) | Wrightmedicaltechnologyinc | 1998-09-11 |