R3 XLPE LINERS
FDA 510(k) clearance K113848 · decided 2012-04-27
Clearance details
- K-number
- K113848
- Device name
- R3 XLPE LINERS
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-12-29
- Decision date
- 2012-04-27
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- MBL
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| R3 Anteverted Liners (K182535) | Smith & Nephew, Inc. | 2018-11-19 |
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| DYNASTY BIOFOAM SHELL (K122382) | Wrightmedicaltechnologyinc | 2012-10-22 |
| R3 XLPE ANTEVERTED LINERS (K102370) | Smith & Nephew, Inc. | 2011-01-19 |
| COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS (K093363) | Smith & Nephew, Inc. | 2010-01-26 |
| R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS (K092386) | Smith & Nephew, Inc. | 2009-11-03 |
| SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM (K070756) | Smith & Nephew, Inc. | 2007-06-06 |
| REFLECTION 3 ACETABULAR SYSTEM (K061253) | Smith & Nephew, Inc. | 2006-05-31 |
| REFLECTION DUAL DIMENSION SHELL (K960094) | Smith & Nephew Richards, Inc. | 1996-03-27 |
| LOGYK ACETABULAR COMPONENT SYSTEM (K931107) | Arthronics, Inc. | 1994-03-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE recall (Z-1928-2013) | Smith & Nephew Inc | 2013-08-08 |
| R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE recall (Z-1929-2013) | Smith & Nephew Inc | 2013-08-08 |
PMA approvals by this applicant
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|---|---|---|
| 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 |