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Smith & Nephew, Inc. FDA Approvals
0 new drug approvals and 57 device clearances on file. Matched by name to SNN.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| LANDMARK Total Knee System510(k)Sep 8, 2026Orthopedic |
| Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)510(k)Jul 9, 2026Orthopedic |
| TESSA Spatial Surgery System; INTELLIO Tablet (72205455)510(k)Jul 6, 2026Orthopedic |
| AETOS Shoulder System - CONCELOC Glenoids510(k)Apr 6, 2026Orthopedic |
| AETOS Shoulder System Meta Humeral Prosthesis Size 0510(k)Oct 29, 2025Orthopedic |
| AETOS Shoulder System Stemless Humeral Prosthesis510(k)Oct 3, 2025Orthopedic |
| BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)510(k)Jun 25, 2025Orthopedic |
| TRIGEN Stable Lock Nut & Washer510(k)Jun 12, 2025Orthopedic |
| LEGION Total Knee System510(k)Apr 2, 2025Orthopedic |
| CATALYSTEM Femoral Stems510(k)Mar 28, 2025Orthopedic |
| TRIGEN META-TAN Trochanteric Antegrade Nail510(k)Dec 9, 2024Orthopedic |
| AETOS Shoulder System Stemless Humeral Prosthesis510(k)Nov 20, 2024Orthopedic |
| JOURNEY II Unicompartmental Knee System (JOURNEY II UK)510(k)Oct 30, 2024Orthopedic |
| Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems510(k)Oct 21, 2024Orthopedic |
| OR3O Dual Mobility System510(k)Oct 7, 2024Orthopedic |
| TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System510(k)Sep 20, 2024Orthopedic |
| TRIGEN INTERTAN 10S Nail System510(k)Aug 22, 2024Orthopedic |
| CATALYSTEM Femoral Stems510(k)Jun 27, 2024Orthopedic |
| Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue510(k)Jun 20, 2024Orthopedic |
| CORIOGRAPH Knee Pre-Op Plan510(k)Mar 18, 2024Orthopedic |
| ACCORD Cable System510(k)Mar 13, 2024Orthopedic |
| Cannulated Screw System510(k)Dec 21, 2023Orthopedic |
| OR3O Dual Mobility Liners510(k)Oct 27, 2023Orthopedic |
| Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)510(k)Aug 9, 2023Orthopedic |
| HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)510(k)Aug 4, 2023Orthopedic |
| TANDEM Hip System510(k)Jul 19, 2023Orthopedic |
| TRIGEN META-NAIL Nail System510(k)Jun 14, 2023Orthopedic |
| AETOS Shoulder System510(k)Jun 7, 2023Orthopedic |
| 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 Baseplates510(k)May 4, 2023Orthopedic |
| Cemented Tibia Baseplate no Taper with JRNY Lock510(k)Mar 30, 2023Orthopedic |
| ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device510(k)Feb 17, 2023Orthopedic |
| AETOS Shoulder System510(k)Jan 3, 2023Orthopedic |
| MAVERICK Mini External Fixation System510(k)Dec 8, 2022Orthopedic |
| Smith & Nephew Intramedullary Nail Systems510(k)Nov 14, 2022Orthopedic |
| JOURNEY II UK and ENGAGE Cementless Partial Knee System510(k)Oct 28, 2022Orthopedic |
| EVOS Wrist Spanning Plate510(k)Oct 18, 2022Orthopedic |
| 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 screws510(k)Sep 29, 2022Orthopedic |
| Acute QC Strut and Components510(k)Aug 25, 2022Orthopedic |
| OR3O Dual Mobility System510(k)Aug 18, 2022Orthopedic |
| Cemented Round Patella with JRNY Pegs510(k)Jul 26, 2022Orthopedic |
| Smith & Nephew Hip Systems510(k)Jul 1, 2022Orthopedic |
| Legion Inserts with JRNY Lock510(k)Apr 26, 2022Orthopedic |
| TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)510(k)Mar 11, 2022Orthopedic |
| MAVERICK External Fixation System510(k)Feb 11, 2022Orthopedic |
| R3 Large Head Liners510(k)Jan 19, 2022Orthopedic |
| Porous Patella and Porous Tibia Baseplate510(k)Oct 1, 2021Orthopedic |
| VISIONAIRE UK Patient Matched Cutting Guides510(k)Sep 16, 2021Orthopedic |
| Journey II Mid-Level Tibial Inserts510(k)Aug 17, 2021Orthopedic |
| SMART Taylor Spatial Frame510(k)Jul 29, 2021Orthopedic |
| POLARSTEM Cemented Femoral Stem510(k)Jul 22, 2021Orthopedic |
| POLARSTEM Calcar Reamer Guide510(k)Jul 19, 2021Orthopedic |
| Smith & Nephew Plates and Screws510(k)Jun 29, 2021Orthopedic |
| LEGION CR Porous Plus HA Femoral Components510(k)May 24, 2021Orthopedic |
| Extended HA Half Pins510(k)Apr 2, 2021Orthopedic |
| LEGION Porous CR Narrow Femoral Components510(k)Mar 25, 2021Orthopedic |
| FAST-FIX FLEX510(k)Feb 1, 2021General, Plastic Surgery |
| EVOS Large Fragment Plating System510(k)Jan 27, 2021Orthopedic |