ERS RADIAL HEAD REPLACEMENT
FDA 510(k) clearance K000658 · decided 2000-05-11
Clearance details
- K-number
- K000658
- Device name
- ERS RADIAL HEAD REPLACEMENT
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-28
- Decision date
- 2000-05-11
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- KWI
- Device class
- 2
- Regulation number
- 888.3170
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, 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 |
|---|---|---|
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |
| CERAMAX® ceramic total hip system (P070026/S120) | DePuy Orthopaedics, Inc. | 2025-06-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S119) | DePuy Orthopaedics, Inc. | 2025-04-04 |
| DePuy Ceramax Ceramic Total Hip System (P070026/S114) | DePuy Orthopaedics, Inc. | 2025-03-19 |
| Ceramax Ceramic Hip System (P070026/S117) | DePuy Orthopaedics, Inc. | 2025-02-21 |
| Ceramax® Ceramic Total Hip System (P070026/S116) | DePuy Orthopaedics, Inc. | 2025-02-11 |