Medical Device Manufacturer · US , Mchenry , IL

Smith & Nephew, Inc.

529 submissions · 516 cleared · Since 1980
529
Total
516
Cleared
0
Denied

Smith & Nephew, Inc. — FDA 510(k) Submissions

Smith & Nephew, Inc. has submitted 529 FDA 510(k) premarket notifications since 1980, of which 516 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Plate, Fixation, Bone, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Screw, Fixation, Bone, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented . Use the specialty filter in the sidebar to narrow results.

529 devices
1–25 of 529
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K252416 · KWS Prosthesis, Shoulder,... · Orthopedic
Oct 2025 89d
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · PKC Prosthesis, Total... · Orthopedic
Oct 2025 88d
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)
K251627 · MBI Fastener, Fixation,... · Orthopedic
Jun 2025 28d
TRIGEN Stable Lock Nut & Washer
K243608 · JDS Nail, Fixation, Bone · Orthopedic
Jun 2025 202d
LEGION Total Knee System
K250677 · JWH Prosthesis, Knee,... · Orthopedic
Apr 2025 27d
CATALYSTEM Femoral Stems
K250571 · LZO Prosthesis, Hip,... · Orthopedic
Mar 2025 30d
TRIGEN META-TAN Trochanteric Antegrade Nail
K243364 · HSB Rod, Fixation,... · Orthopedic
Dec 2024 41d
AETOS Shoulder System Stemless Humeral Prosthesis
K240716 · PKC Prosthesis, Total... · Orthopedic
Nov 2024 250d
JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
K242711 · HSX Prosthesis, Knee,... · Orthopedic
Oct 2024 51d
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
K240783 · JDI Prosthesis, Hip,... · Orthopedic
Oct 2024 214d
OR3O Dual Mobility System
K242375 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2024 59d
TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System
K240061 · JDS Nail, Fixation, Bone · Orthopedic
Sep 2024 255d
TRIGEN INTERTAN 10S Nail System
K241804 · JDS Nail, Fixation, Bone · Orthopedic
Aug 2024 62d
CATALYSTEM Femoral Stems
K240381 · LZO Prosthesis, Hip,... · Orthopedic
Jun 2024 140d
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-blue
K241435 · MBI Fastener, Fixation,... · Orthopedic
Jun 2024 30d
CORIOGRAPH Knee Pre-Op Plan
K240113 · PBF Orthopaedic Surgical... · Orthopedic
Mar 2024 62d
ACCORD Cable System
K233949 · JDQ Cerclage, Fixation · Orthopedic
Mar 2024 90d
Cannulated Screw System
K233396 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2023 79d
OR3O Dual Mobility Liners
K232667 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2023 56d
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)
K231376 · MBI Fastener, Fixation,... · Orthopedic
Aug 2023 89d
HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)
K232005 · MBI Fastener, Fixation,... · Orthopedic
Aug 2023 29d
TANDEM Hip System
K231448 · LZY Prosthesis, Hip, Hemi-,... · Orthopedic
Jul 2023 62d
TRIGEN META-NAIL Nail System
K230761 · JDS Nail, Fixation, Bone · Orthopedic
Jun 2023 86d
AETOS Shoulder System
K230572 · KWS Prosthesis, Shoulder,... · Orthopedic
Jun 2023 98d
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
K230653 · JWH Prosthesis, Knee,... · Orthopedic
May 2023 56d

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