DEPALMA ELBOW
FDA 510(k) clearance K801574 · decided 1980-10-31
Clearance details
- K-number
- K801574
- Device name
- DEPALMA ELBOW
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-09
- Decision date
- 1980-10-31
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- JDB
- Device class
- 2
- Regulation number
- 888.3160
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 PROSTHESIS (K100562) | Tornier, Inc. | 2010-06-29 |
| 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 |
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 |