RADIAL HEAD PROSTHESIS
FDA 510(k) clearance K992220 · decided 2000-02-25
Clearance details
- K-number
- K992220
- Device name
- RADIAL HEAD PROSTHESIS
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-07-01
- Decision date
- 2000-02-25
- Days to decision
- 239 days
- Clearance type
- Abbreviated
- Product code
- KWI
- Device class
- 2
- Regulation number
- 888.3170
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, 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 |
|---|---|---|
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |