TEMA Elbow System
FDA 510(k) clearance K181362 · decided 2019-02-16
Clearance details
- K-number
- K181362
- Device name
- TEMA Elbow System
- Applicant
- Lima Corporate S.P.A.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-23
- Decision date
- 2019-02-16
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- JDC
- Device class
- 2
- Regulation number
- 888.3150
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Villanova Di San Daniele Del Friuli, IT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lima Corporate S.P.A.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| 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
| Record | Firm | Date |
|---|---|---|
| TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's recall (Z-1261-2023) | Limacorporate S.p.A | 2023-03-16 |