R3 Anteverted Liners
FDA 510(k) clearance K182535 · decided 2018-11-19
Clearance details
- K-number
- K182535
- Device name
- R3 Anteverted Liners
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-14
- Decision date
- 2018-11-19
- Days to decision
- 66 days
- Clearance type
- Special
- Product code
- MBL
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cordova, 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 |
|---|---|---|
| Prime BIOFOAM® Multi-Hole Shells (K201157) | Microport Orthopedics, Inc. | 2021-08-24 |
| R3 HA Coated Acetabular Shells (K201701) | Smith & Nephew, Inc. | 2020-10-06 |
| OXINIUM DH Fermoral Heads (K161233) | Smith & Nephew, Inc. | 2016-12-14 |
| DYNASTY BIOFOAM SHELL (K122382) | Wrightmedicaltechnologyinc | 2012-10-22 |
| R3 XLPE LINERS (K113848) | Smith & Nephew, Inc. | 2012-04-27 |
| 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
No recalls on record reference this clearance.
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 |