TANDEM Hip System
FDA 510(k) clearance K231448 · decided 2023-07-19
Clearance details
- K-number
- K231448
- Device name
- TANDEM Hip System
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-18
- Decision date
- 2023-07-19
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- LZY
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, 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 |
|---|---|---|
| ENDO HEAD (K111145) | Medacta International | 2011-08-16 |
| PRE-POWDERED NITRILE EXAMINATION GLOVES (K974442) | P.T. Latexindo Tobaperkasa | 1998-01-05 |
| BHR BIPOLAR FEMORAL HEAD COMPONENT (K915528) | Implantology Corp. | 1993-06-29 |
| IONGUARD TITANIUM MODULAR HEADS (K915548) | Biomet, Inc. | 1992-03-10 |
| MODULAR CATHCART FRACTURE SYSTEM (K903084) | Depuy, Inc. | 1990-10-03 |
| UNI-POLAR HEAD (K896580) | Richards Medical Co., Inc. | 1990-02-15 |
| FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (K892059) | Protek, Inc. | 1989-07-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D recall (Z-0326-2025) | Smith & Nephew, Inc. | 2024-11-07 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |