Data / Medical devices / Switzerland / Smith & Nephew Orthopaedics AG
Smith & Nephew Orthopaedics AG: FDA-registered device maker in AARAU Aargau, Switzerland, 42 510(k) clearances
Smith & Nephew Orthopaedics AG is registered with the FDA (registration 9613369) in AARAU Aargau, Switzerland. It lists 33 device types. The FDA files 42 510(k) clearances under its listings, the newest dated March 28, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9613369
- FEI number
- 3002807893
- Address
- Schachenallee 29 Dammweg 39, AARAU Aargau, Switzerland, 5001
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 22, 1978
- Registered through
- 2027
- Brand names listed
- 1.5 MM TENDON DRILL PIN, 1.5mm Guidewire, 12", 72202189, 10MM DILATOR, 11MM DILATOR, 12MM DILATOR, 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE, 2.7 MM DILATOR, 3.5 MM DILATOR 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 28, 2025 | K250571 | CATALYSTEM Femoral Stems | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 7, 2024 | K242375 | OR3O Dual Mobility System | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| June 27, 2024 | K240381 | CATALYSTEM Femoral Stems | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 19, 2023 | K231448 | TANDEM Hip System | LZY | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 4, 2023 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 1, 2022 | K211176 | Smith & Nephew Hip Systems | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 22, 2021 | K203175 | POLARSTEM Cemented Femoral Stem | LZO | 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 |
| October 31, 2019 | K191002 | OR3O Dual Mobility System | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 9, 2018 | K181533 | EVOS Wrist Fracture Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 30, 2017 | K171934 | Birmingham Hip (BH) Dual Mobility Insert | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 18, 2016 | K162078 | EVOS Small Fragment Plating System | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 20, 2015 | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| March 24, 2015 | K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 7, 2014 | K132296 | D-RAD SMART PACK | HRS | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 22, 2013 | K132435 | SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 10, 2013 | K130728 | POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA | LZO | 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 |
| August 28, 2012 | K122296 | SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 23, 2012 | K122244 | POLARCUP DUAL MOBILITY SYSTEM | LPH | 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 |
| July 19, 2012 | K120211 | SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING | LZO | 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 |
| October 14, 2011 | K110135 | POLARCUP DUAL MOBILITY SYSTEM | LPH | 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 |
| May 5, 2010 | K100412 | BIOLOX DELTA CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 15, 2010 | K093991 | SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS | LZO | 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 |
| June 9, 2008 | K072852 | SL-PLUS STANDARD AND LATERAL HIP STEMS | LZO | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 20, 2007 | K072858 | TC-PLUS PRIMARY KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 16, 2007 | K070278 | POLARCUP DUAL MOBILITY SYSTEM | LPH | Substantially Equivalent | Plus Orthopedics AG | accessdata.fda.gov |
| May 3, 2006 | K060742 | LEGION COBALT CHROME REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 23, 2003 | K023743 | SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM | KWY | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 2, 2001 | K011719 | PLUS CANCELLOUS BONE SCREWS | HWC | Substantially Equivalent | Plus Orthopedics | accessdata.fda.gov |
| December 15, 2000 | K002747 | REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS | LPH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| October 13, 2000 | K000666 | TC-PLUS SOLUTION KNEE | JWH | Substantially Equivalent | Plus Orthopedics | accessdata.fda.gov |
| August 2, 1996 | K962137 | GENESIS II CONSTRAINED SYSTEM | JWH | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| March 27, 1996 | K960094 | REFLECTION DUAL DIMENSION SHELL | MBL | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| August 22, 1995 | K951987 | GENESIS II TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| July 6, 1995 | K946236 | PROFIX CONFORMING PLUS TIBIAL INSERT | KWH | Substantially Equivalent | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
| January 9, 1995 | K933958 | RICHARDS TOTAL KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Smith & Nephew Richards, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 22, 2020 | 86099 | Class II | Terminated | POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493 - Product Usage: Once the appropriate trial rasp size is in place, the adapter is removed and the calcar reamer guide (75102205) is posit | Multiple lots being recalled due to a product design issue | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- All makers of Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Updated March 28, 2025. 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.