MODULAR RADIAL HEAD REPLACEMENT DEVICE
FDA 510(k) clearance K040611 · decided 2004-06-04
Clearance details
- K-number
- K040611
- Device name
- MODULAR RADIAL HEAD REPLACEMENT DEVICE
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-03-08
- Decision date
- 2004-06-04
- Days to decision
- 88 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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| 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 |
|---|---|---|
| ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic i recall (Z-1615-2014) | Biomet, Inc. | 2014-05-13 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |