Data / Medical devices / United States / Smith & Nephew, Inc.
Smith & Nephew, Inc.: FDA-registered device maker in Memphis, TN, United States, 205 510(k) clearances
Smith & Nephew, Inc. is registered with the FDA (registration 3038503932) in Memphis, TN, United States. It lists 102 device types. The FDA files 205 510(k) clearances under its listings, the newest dated September 29, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3038503932
- Address
- 4340 Swinnea Rd, Memphis, TN, United States, 38118
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Manufacturer
- First device listed
- February 22, 1978
- Registered through
- 2027
- Brand names listed
- (6) MINITAPE (BLUE) 39.5, (6) MINITAPE (COBRAID BLUE) 39.5, (6) MINITAPE (COBRAID WHITE) 39.5, 1.2 ENDOBUTTON CL ULTRA PAC, 1.2 RAP-PAC A LATEX FREE, 1.2 RAP-PAC A, 72202796, 1.2 RAP-PAC B LATEX FREE, 1.2 RAP-PAC B, 72202797 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 205.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2022 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws | JDO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 26, 2022 | K220896 | Legion Inserts with JRNY Lock | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 11, 2022 | K213874 | MAVERICK External Fixation System | JDW | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 19, 2022 | K211330 | R3 Large Head Liners | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 3, 2021 | K212537 | REAL INTELLIGENCE CORI (CORI) | OLO | Substantially Equivalent | Blue Belt Technologies, Inc. | accessdata.fda.gov |
| October 1, 2021 | K211221 | Porous Patella and Porous Tibia Baseplate | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 17, 2021 | K211671 | Journey II Mid-Level Tibial Inserts | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 19, 2021 | K211548 | POLARSTEM Calcar Reamer Guide | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 29, 2021 | K210837 | Smith & Nephew Plates and Screws | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 25, 2021 | K210566 | LEGION Porous CR Narrow Femoral Components | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 8, 2020 | K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation | KTT | Substantially Equivalent | Smith & Nephew | accessdata.fda.gov |
| July 22, 2020 | K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 23, 2016 | K161264 | TRIGEN Low Profile Bone Screws | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 29, 2014 | K140555 | JOURNEY II BCS CONSTRAINED INSERTS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 15, 2014 | K133662 | SMITH & NEPHEW CANNULATED CAPTURED SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 7, 2014 | K140814 | EVOS MINI-FRAGMENT PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 4, 2014 | K132886 | SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 30, 2013 | K132357 | SMITH & NEPHEW ULTRATAPE | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 4, 2013 | K130748 | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 28, 2013 | K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION | JDI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 14, 2013 | K130479 | ILIZAROV DRILL TIP WIRES | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 3, 2013 | K123159 | SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 23, 2013 | K123579 | FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 24, 2012 | K123012 | SMITH & NEPHEW SMF HIP STEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 19, 2012 | K122170 | SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 16, 2012 | K122139 | SMITH & NEPHEW R3 CONSTRAINED LINERS | KWZ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 15, 2012 | K121627 | SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 5, 2012 | K113039 | SMITH & NEPHEW RADIOPAQUE TRIAL NECKS | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 7, 2012 | K121714 | SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS | HSD | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 13, 2012 | K121443 | JOURNEY II CR KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 7, 2012 | K121393 | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 7, 2012 | K120871 | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION | JDW | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 27, 2012 | K113848 | R3 XLPE LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 19, 2012 | K113789 | MODULAR PROXIMALLY FLUTED HIP STEM | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 4, 2012 | K120667 | VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 27, 2012 | K113482 | JOURNEY II DEEP DISHED ARTICULAR INSERTS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 5, 2012 | K113038 | SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 20, 2011 | K112941 | LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 11, 2011 | K111994 | SMITH & NEPHEW CANNULATED SCREWS AND WASHERS | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 16, 2011 | K111711 | JOURNEY II BCS KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 9, 2011 | K111635 | SMITH & NEPHEW RJ CONSTRAINED LINERS | KWZ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 12, 2011 | K110670 | VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 1, 2011 | K111025 | TRIGEN LOW PROFILE BONE SCREW | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 22, 2011 | K110837 | REVISION PROTHESIS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 14, 2011 | K110240 | SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 11, 2011 | K110101 | TAPER OXINIUM FEMORAL HEAD | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 8, 2011 | K101377 | SMITH & NEWPHEW ULTRABRAID II SUTURE | GAT | Substantially Equivalent | Smith & Newphew, Inc. | accessdata.fda.gov |
| February 8, 2011 | K110069 | SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 31, 2011 | K103256 | SMITH & NEPHEW SMF HIP STEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 19, 2011 | K102370 | R3 XLPE ANTEVERTED LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 5, 2010 | K102069 | JOURNEY UNICONDYLAR TIBIAL BASEPLATES | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 27, 2010 | K093047 | SMITH & NEPHEW CIRCULAR FIXATION SYSTEM | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 2, 2010 | K100795 | JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 26, 2010 | K101499 | JOURNEY CR KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 15, 2010 | K100481 | SMITH & NEPHEW MDF MODULAR SLEEVE | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 13, 2010 | K100897 | LEGION POROUS + HA TIBIAL BASEPLATES | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 5, 2010 | K100412 | BIOLOX DELTA CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 4, 2010 | K100325 | PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 26, 2010 | K092748 | SURESHOT TAN NAILS AND ACCESSORIES | HSB | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 21, 2010 | K090982 | SMITH & NEPHEW HIP SYSTEMS WITH HA | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 14, 2010 | K093746 | VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| February 23, 2010 | K100107 | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 26, 2010 | K093363 | COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 21, 2009 | K091543 | LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 15, 2009 | K093056 | SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM | NPJ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 3, 2009 | K092386 | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 29, 2009 | K091014 | JOURNEY BCS KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 11, 2009 | K092497 | SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 | OLO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 30, 2009 | K092015 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 8, 2009 | K090926 | SMITH & NEPHEW RAIL SYSTEM | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 4, 2009 | K090675 | SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 3, 2009 | K090656 | INTERTAN CHS LIMITED COLLAPSE SET SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 11, 2009 | K083762 | BIOLOX DELTA CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 3, 2009 | K083566 | R3 CONSTRAINED LINER, CONSTRAINED LINER | KWZ | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 30, 2009 | K083226 | SMITH & NEPHEW PEEK INTERFERENCE SCREW | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| January 7, 2009 | K083032 | PERI-LOC BONE PLATING AND SCREW SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 25, 2008 | K082358 | SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 17, 2008 | K082516 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 31, 2008 | K081124 | MDF REVISION HIP SYSTEM | MEH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 24, 2008 | K081351 | MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 23, 2008 | K081111 | LEGION HINGE KNEE SYSTEM | KRO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 15, 2008 | K072817 | ECHELON TITANIUM HIP SYSTEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 8, 2008 | K080625 | SMITH & NEPHEW MIS HIP STEM WITH STIKTITE | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 10, 2008 | K080434 | INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW | JDO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 7, 2008 | K072212 | JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE | KTT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 10, 2008 | K072417 | SMITH & NEPHEW MIS HIP STEM | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 20, 2007 | K073325 | LEGION POROUS PRIMARY | MBH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 20, 2007 | K073175 | JOURNEY UNICONDYLAR FEMORAL IMPLANT | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 6, 2007 | K072531 | LEGION STEM WITH HOLES | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 19, 2007 | K072818 | PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 5, 2007 | K071160 | REFLECTION, TANDEM UNIPOLAR | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 19, 2007 | K071071 | CROSSLINKED POLYETHYLENE ARTICULAR INSERTS | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 8, 2007 | K071563 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 6, 2007 | K070756 | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM | MBL | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 15, 2006 | K062216 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 10, 2006 | K061783 | KNEE FUSION NAIL | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 4, 2006 | K061779 | COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 11, 2006 | K061011 | COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE | HSX | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 8, 2006 | K061352 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 6, 2006 | K061019 | TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS | JDS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal
- All makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Updated September 29, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.