Data / Medical devices / United States / Smith & Nephew, Inc.

Smith & Nephew, Inc.: FDA-registered device maker in Memphis, TN, United States, 302 510(k) clearances

Name: Smith & Nephew, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Smith & Nephew, Inc. is registered with the FDA (registration 3007366790) in Memphis, TN, United States. It lists 113 device types. The FDA files 302 510(k) clearances under its listings, the newest dated September 8, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Smith & Nephew, Inc.

FDA registration number: 3007366790
FEI number: 3007282753
Address: 3303 E Holmes 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: 1.5 MM TENDON DRILL PIN, 1.5mm Guidewire, 12", 72202189, 1.6MM DRILL & GUIDE DYNOMITE 2, 1.8MM DRILL & GUIDE SPYROMITE/MINI 2, 10 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED, 10.5 MM CANNULATED DRILL, 10.5 MM ENDOSCOPIC CANNULATED DRILL BIT, 10.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	LXT	2	Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Manufacturer	accessdata.fda.gov
Bender	HXW	1	Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Bit, Surgical	GFG	1	Manufacturer	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Manufacturer	accessdata.fda.gov
Broach	HTQ	1	Manufacturer	accessdata.fda.gov
Caliper	KTZ	1	Manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Cement Obturator	LZN	2	Manufacturer	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Manufacturer	accessdata.fda.gov
Clip, Implantable	FZP	2	Manufacturer	accessdata.fda.gov
Crutch	IPR	1	Manufacturer	accessdata.fda.gov
Curette	HTF	1	Manufacturer	accessdata.fda.gov
Cutter, Wire	HXZ	1	Manufacturer	accessdata.fda.gov
Device, Fixation, Proximal Femoral, Implant	JDO	2	Manufacturer	accessdata.fda.gov
Dispenser, Cement	KIH	1	Manufacturer	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Manufacturer	accessdata.fda.gov
Elevator	HTE	1	Manufacturer	accessdata.fda.gov
Evacuator, Vapor, Cement Monomer	JDY	1	Manufacturer	accessdata.fda.gov
Extractor	HWB	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Forceps, Wire Holding	HYA	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Goniometer, Nonpowered	KQW	1	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Hammer, Surgical	FZY	1	Manufacturer	accessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	OQG	2	Manufacturer	accessdata.fda.gov
Hook, Bone	KIK	1	Manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer	accessdata.fda.gov
Knee Arthroplasty Implantation System	OOG	2	Manufacturer	accessdata.fda.gov
Lavage, Jet	FQH	2	Manufacturer	accessdata.fda.gov
Mallet	HXL	1	Manufacturer	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Acetabular, Hip, Prosthesis	JDJ	2	Manufacturer	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Manufacturer	accessdata.fda.gov
Nail, Fixation, Bone	JDS	2	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Orthopaedic Surgical Planning And Instrument Guides	PBF	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
Osteotome	HWM	1	Manufacturer	accessdata.fda.gov
Passer	HWQ	1	Manufacturer	accessdata.fda.gov
Phantom, Anthropomorphic, Radiographic	IXG	1	Manufacturer	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Manufacturer	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Pliers, Surgical	HTC	1	Manufacturer	accessdata.fda.gov
Positioner, Socket	KIL	1	Manufacturer	accessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, Polymer	KWI	2	Manufacturer	accessdata.fda.gov
Prosthesis, Finger, Constrained, Polymer	KYJ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Femoral Component, Cemented, Metal	JDG	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal Ball	LZY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	MBL	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	NPJ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	KRO	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer	NJD	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	KRQ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	MBV	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	2	Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Manufacturer	accessdata.fda.gov
Prosthesis, Toe, Constrained, Polymer	KWH	2	Manufacturer	accessdata.fda.gov
Punch, Surgical	LRY	1	Manufacturer	accessdata.fda.gov
Rasp	HTR	1	Manufacturer	accessdata.fda.gov
Rasp, Frontal-Sinus	KAZ	1	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Retention Device, Suture	KGS	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Ring Cutter	FNS	1	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Manufacturer	accessdata.fda.gov
Saw, Powered, And Accessories	HAB	1	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Software For Diagnosis/Treatment	OSN	2	Manufacturer	accessdata.fda.gov
Spatula, Orthopedic	HXR	1	Manufacturer	accessdata.fda.gov
Staple Driver	HXJ	1	Manufacturer	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Trephine	HWK	1	Manufacturer	accessdata.fda.gov
Twister, Wire	HXS	1	Manufacturer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Manufacturer	accessdata.fda.gov
Washer, Bolt, Nut, Non-Spinal, Metallic	NDG	2	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.fda.gov

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 302.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 8, 2026	K261462	LANDMARK Total Knee System	MBH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
June 12, 2025	K243608	TRIGEN Stable Lock Nut & Washer	JDS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
April 2, 2025	K250677	LEGION Total Knee System	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
March 28, 2025	K250571	CATALYSTEM Femoral Stems	LZO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
February 19, 2025	K241666	EVOS Pelvic and Acetabular System	HRS	Substantially Equivalent	Smith & Nephew	accessdata.fda.gov
December 9, 2024	K243364	TRIGEN META-TAN Trochanteric Antegrade Nail	HSB	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 30, 2024	K242711	JOURNEY II Unicompartmental Knee System (JOURNEY II UK)	HSX	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 21, 2024	K240783	Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems	JDI	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
September 20, 2024	K240061	TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System	JDS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
September 3, 2024	K240487	EVOS Patella Plates	HRS	Substantially Equivalent	Smith & Nephew	accessdata.fda.gov
August 22, 2024	K241804	TRIGEN INTERTAN 10S Nail System	JDS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
June 27, 2024	K240381	CATALYSTEM Femoral Stems	LZO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
March 18, 2024	K240139	Real Intelligence CORI	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
March 18, 2024	K240113	CORIOGRAPH Knee Pre-Op Plan	PBF	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
March 13, 2024	K233949	ACCORD Cable System	JDQ	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 14, 2023	K233670	Ascension Silicone MCP; Ascension Silicone PIP	KYJ	Substantially Equivalent	Ascension Orthopedics, Inc.	accessdata.fda.gov
October 27, 2023	K232667	OR3O Dual Mobility Liners	LPH	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 30, 2023	K223762	Smith & Nephew ACCORD Cable System	HRS	Substantially Equivalent	Smith & Nephew	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
March 30, 2023	K230555	Cemented Tibia Baseplate no Taper with JRNY Lock	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 8, 2022	K223112	MAVERICK Mini External Fixation System	JDW	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 14, 2022	K210980	Smith & Nephew Intramedullary Nail Systems	HSB	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 18, 2022	K213123	EVOS Wrist Spanning Plate	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
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
August 25, 2022	K221792	Acute QC Strut and Components	OSN	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
August 18, 2022	K220959	OR3O Dual Mobility System	LPH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
July 26, 2022	K221939	Cemented Round Patella with JRNY Pegs	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
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
September 16, 2021	K211512	VISIONAIRE UK Patient Matched Cutting Guides	HSX	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 29, 2021	K210953	SMART Taylor Spatial Frame	KTT	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
April 2, 2021	K210784	Extended HA Half Pins	JDW	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
January 27, 2021	K203405	EVOS Large Fragment Plating System	HRS	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
November 16, 2020	K202762	Circular Fixation with Balanced Cable Transport	KTT	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 16, 2020	K201918	EVOS Large Fragment Plating System	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 6, 2020	K201701	R3 HA Coated Acetabular Shells	MBL	Substantially Equivalent	Smith & Nephew, Inc.	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
June 4, 2020	K200227	Journey II XR Knee Instrument	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
March 13, 2020	K200407	LEGION Inserts with JRNY Lock	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
February 28, 2020	K193029	CONQUEST FN	JDO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 21, 2019	K190439	Engage Partial Knee System	NJD	Substantially Equivalent	Engage Uni, LLC	accessdata.fda.gov
October 31, 2019	K191002	OR3O Dual Mobility System	LPH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 25, 2019	K190847	REDAPT Blade Augments	LPH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
March 11, 2019	K190253	EVOS Small Fragment Upper Extremity Plates Line Additions	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
February 11, 2019	K190085	Journey II Unicompartmental Knee System	HSX	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 19, 2018	K182535	R3 Anteverted Liners	MBL	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 16, 2018	K182109	REDAPT Modular Acetabular Shell	LPH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
September 24, 2018	K181366	REDAPT Porous Acetabular Shell	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
April 24, 2018	K180277	Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter	OLO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
March 5, 2018	K180334	LEGION Knee System	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
January 8, 2018	K173293	EVOS Small Fragment Upper Extremity Plates	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 22, 2017	K172785	CONQUEST FN	JDO	Substantially Equivalent	Smith & Nephew	accessdata.fda.gov
November 21, 2017	K171073	Smith & Nephew, Inc. REDAPT Augments	LPH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 16, 2017	K173331	JOURNEY II XR Knee Instruments	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 3, 2017	K172684	Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem	LPH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
August 23, 2017	K172262	EVOS Small Fragment Plating System	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
June 19, 2017	K162641	Smith & Nephew, Inc. R3 Constrained Liner	KWZ	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
June 14, 2017	K170457	EVOS Small Fragment Lower Extremity Plates	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
May 22, 2017	K170282	Smith & Nephew VISIONAIRE Adaptive Guides	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
May 11, 2017	K170648	ANTHEM CR Total Knee System	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
May 3, 2017	K170977	SURESHOT Distal Targeting System V4.0 Trauma Interface	OLO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
May 1, 2017	K162303	REDAPT Sleeved Monolithic Revision Stems	MEH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
April 28, 2017	K170280	Smith & Nephew SURESHOT Distal Targeting System V4.0	OLO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
April 24, 2017	K170887	EVOS Small Fragment Plating System	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
January 13, 2017	K162775	Legion Cone System	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 14, 2016	K161233	OXINIUM DH Fermoral Heads	MBL	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
November 18, 2016	K162078	EVOS Small Fragment Plating System	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 17, 2016	K160923	REDAPT Anteverted Cemented Liner	JDI	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 15, 2016	K161665	VLP Wrist Fracture System	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
March 17, 2016	K152686	CONQUEST FN	JDO	Substantially Equivalent	Smith & Nephew	accessdata.fda.gov
November 16, 2015	K150790	REDAPT Porous Acetabular Shell and Cemented Liner	LPH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 12, 2015	K152976	VLP Mini-Mod Talus Plates	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 28, 2015	K152315	JOURNEY II Uni Tibial Base and Insert	HSX	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 27, 2015	K150241	Genesis II XLPE Resurfacing Patellar Components	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 21, 2015	K152726	JOURNEY II XR Knee System	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
September 3, 2015	K151902	REDAPT¿ Revision Femoral System	LZO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
July 28, 2015	K151118	Smith and Nephew Legion Hinge Knee System	KRO	Substantially Equivalent	Smith & Nephew	accessdata.fda.gov
February 12, 2015	K143226	Visionaire Disposable Instruments	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 22, 2014	K142807	ANTHEM PS Total Knee System	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 18, 2014	K143050	VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
November 14, 2014	K141471	JOURNEY II XR KNEE SYSTEM	JWH	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
January 7, 2014	K132296	D-RAD SMART PACK	HRS	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 11, 2013	K130708	SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov

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Updated September 8, 2026. 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.