LATITUDE ELBOW PROSTHESIS
FDA 510(k) clearance K100562 · decided 2010-06-29
Clearance details
- K-number
- K100562
- Device name
- LATITUDE ELBOW PROSTHESIS
- Applicant
- Tornier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-01
- Decision date
- 2010-06-29
- Days to decision
- 120 days
- Clearance type
- Special
- Product code
- JDB
- Device class
- 2
- Regulation number
- 888.3160
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beverly, MA, 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 - Line extension (K222807) | Lima Corporate S.P.A. | 2022-10-26 |
| LATITUDE EV™ Total Elbow Arthroplasty (K193247) | Tornier, Inc. | 2020-08-05 |
| LATITUDE EV Total Elbow Arthroplasty (K182461) | Tornier, Inc. | 2018-12-27 |
| Latitude EV Total Elbow Arthroplasty (K171010) | Tornier, Inc. | 2017-08-31 |
| RHEAD RADIAL HEAD EXTENDED STEMS (K102180) | Small Bone Innovations, Inc. | 2010-12-20 |
| LATITUDE ELBOW PROTHESIS (K070787) | Tornier | 2007-08-24 |
| SBI LATERAL RADIO CAPITELLUM (K070236) | Small Bone Innovations, Inc. | 2007-02-21 |
| RHS (K060438) | Tornier | 2006-04-18 |
| SBI RADIO-CAPITELLAR IMPLANT (K060038) | Small Bone Innovations, Inc. | 2006-03-30 |
| TORNIER ELBOW PROSTHESIS (K050848) | Tornier | 2005-07-14 |
| MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS (K031218) | Tornier | 2003-05-16 |
| TORNIER TOTAL ELBOW PROSTHESIS (K011567) | Tornier | 2001-06-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9 recall (Z-1651-2025) | Tornier, Inc | 2025-04-22 |
| Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use recall (Z-3082-2011) | Tornier, Inc | 2011-08-29 |