Zimmer Nexel Total Elbow Ulnar Cement Diverter
FDA 510(k) clearance K150501 · decided 2015-04-23
Clearance details
- K-number
- K150501
- Device name
- Zimmer Nexel Total Elbow Ulnar Cement Diverter
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-26
- Decision date
- 2015-04-23
- Days to decision
- 56 days
- Clearance type
- Traditional
- 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 (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 |
| POROUS COATED DISCOVERY ELBOW (K051975) | Biomet, Inc. | 2005-09-06 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |