AGILITY LP TOTAL ANKLE PROSTHESIS
FDA 510(k) clearance K053569 · decided 2006-03-31
Clearance details
- K-number
- K053569
- Device name
- AGILITY LP TOTAL ANKLE PROSTHESIS
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-22
- Decision date
- 2006-03-31
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- HSN
- Device class
- 2
- Regulation number
- 888.3110
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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| Prophecy Surgical Planning System (K241999) | Wright Medical Technology, Inc. (Stryker) | 2024-11-01 |
| Kinos Total Ankle System (K242868) | Restor3D | 2024-10-18 |
| Kinos Total Ankle System (K241482) | Restor3D | 2024-07-22 |
| APEX 3D Total Ankle Replacement System (K240259) | Paragon 28, Inc. | 2024-06-24 |
| restor3d Kinos Axiom Total Ankle System (K240591) | Restor3D, Inc. | 2024-04-29 |
| QUANTUM® Patient Specific Instrumentation (PSI) System (K231699) | In2bones Sas | 2024-04-23 |
| Kinos Axiom Total Ankle System (K232595) | Restor3D | 2023-11-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |
| CERAMAX® ceramic total hip system (P070026/S120) | DePuy Orthopaedics, Inc. | 2025-06-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S119) | DePuy Orthopaedics, Inc. | 2025-04-04 |
| DePuy Ceramax Ceramic Total Hip System (P070026/S114) | DePuy Orthopaedics, Inc. | 2025-03-19 |
| Ceramax Ceramic Hip System (P070026/S117) | DePuy Orthopaedics, Inc. | 2025-02-21 |
| Ceramax® Ceramic Total Hip System (P070026/S116) | DePuy Orthopaedics, Inc. | 2025-02-11 |