POROUS COATED DISCOVERY ELBOW
FDA 510(k) clearance K051975 · decided 2005-09-06
Clearance details
- K-number
- K051975
- Device name
- POROUS COATED DISCOVERY ELBOW
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-07-21
- Decision date
- 2005-09-06
- Days to decision
- 47 days
- Clearance type
- Special
- Product code
- JDC
- Device class
- 2
- Regulation number
- 888.3150
- 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 |
|---|---|---|
| TEMA Elbow System (K181362) | Lima Corporate S.P.A. | 2019-02-16 |
| Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow (K181307) | Zimmer, Inc. | 2019-01-28 |
| Comprehensive SRS/Nexel Elbow (K153398) | Biomet Manufacturing Corp | 2016-02-03 |
| Zimmer Nexel Total Elbow Ulnar Cement Diverter (K150501) | Zimmer, Inc. | 2015-04-23 |
| ZIMMER NEXEL TOTAL ELBOW (K123862) | Zimmer, Inc. | 2013-03-12 |
| DISCOVERY ELBOW - X-SMALL (K090473) | Biomet Manufacturing Corp | 2009-03-25 |
| ACCLAIM TOTAL ELBOW SYSTEM (K060696) | DePuy Orthopaedics, Inc. | 2006-04-14 |
| COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES (K053189) | Zimmer, Inc. | 2005-12-09 |
| LPS UPPER EXTREMITY (K042664) | Depuy, Inc. | 2004-12-08 |
| COONRAD/MORREY ELBOW CEMENT RESTRICTOR (K040389) | Zimmer, Inc. | 2004-05-17 |
| DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM (K033280) | Biomet, Inc. | 2003-12-19 |
| DISCOVERY ELBOW (K013042) | Biomet Orthopedics, Inc. | 2001-10-10 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Discovery Elbow System Humeral Condyle Set- Hexalobular, REF 114700, Lot 797550 Alloy, Ste recall (Z-1071-2012) | Biomet, Inc. | 2012-02-21 |
| Condyle Kit with Hexalobular, REF 114700 DISCOVERY ELBOW SYSTEM, HUMERAL CONDYLE SET - HEX recall (Z-2660-2011) | Biomet, Inc. | 2011-06-24 |
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 |