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

Smith & Nephew, Inc.: FDA-registered device maker in Memphis, TN, United States, 29 510(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 3005551626) in Memphis, TN, United States. It lists 14 device types. The FDA files 29 510(k) clearances under its listings, the newest dated October 30, 2024. 5 recall events name 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.

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

FDA registration number: 3005551626
Address: 6409 E Holmes Rd, Memphis, TN, United States, 38141
Owner or operator: Smith & Nephew, Inc. (1020279)
Roles: Manufacturer
First device listed: January 9, 2006
Registered through: 2027
Brand names listed: ANTHOLOGY, ANTHOLOGY HIP SYSTEM, Anthology Hip Stems, CPCS Hip Stems, DEUCE, Femoral Heads, GENESIS, GENESIS II KNEE SYSTEM and more

Devices it lists

Device	Product code	Class	Role	Source
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	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, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
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
October 27, 2023	K232667	OR3O Dual Mobility Liners	LPH	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
October 31, 2019	K191002	OR3O Dual Mobility System	LPH	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
July 28, 2015	K151118	Smith and Nephew Legion Hinge Knee System	KRO	Substantially Equivalent	Smith & Nephew	accessdata.fda.gov
August 13, 2012	K121443	JOURNEY II CR KNEE SYSTEM	JWH	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
September 16, 2011	K111711	JOURNEY II BCS KNEE SYSTEM	JWH	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
January 26, 2010	K093363	COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS	MBL	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
May 3, 2006	K060742	LEGION COBALT CHROME REVISION KNEE SYSTEM	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 27, 2005	K052265	SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL	NPJ	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 7, 2005	K052792	ANTHOLOGY HIP STEM	JDI	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
May 31, 2005	K051086	SMITH & NEPHEW PATELLO-FEMORAL IMPLANT	KRR	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
March 14, 2005	K042515	SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
February 18, 2005	K043440	SMITH & NEPHEW, INC. REVISION KNEE SYSTEM	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
July 25, 2003	K030766	OXINIUM FEMORAL HEADS	JDI	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
February 26, 2003	K024340	SMITH & NEPHEW FEMORAL HEADS	JDI	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
February 25, 2003	K030301	UNICONDYLAR FEMORAL COMPONENT	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
October 2, 2002	K022958	TOTAL HIP FEMORAL HEADS AND LINERS	JDI	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
August 19, 2002	K022010	TOTAL KNEE FEMORAL COMPONENT	JWH	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
June 11, 2002	K021673	TOTAL HIP FEMORAL HEAD - 12/14 TAPER	LZO	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
December 5, 1996	K962557	GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT	JWH	Substantially Equivalent for Some Indications	Smith & Nephew Richards, Inc.	accessdata.fda.gov
April 25, 1994	K934353	ZIRCONIUM ALLOY UNI-POLAR HEAD	KWL	Substantially Equivalent	Smith & Nephew Richards, Inc.	accessdata.fda.gov
July 30, 1992	K914878	ZIRCONIUM ALLOY FRMORAL HEAD	JDI	Substantially Equivalent	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
October 2, 2024	95494	Class II	Ongoing	smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic	Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.	accessdata.fda.gov
October 2, 2024	95493	Class II	Ongoing	smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER	Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.	accessdata.fda.gov
April 24, 2024	94555	Class II	Ongoing	smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4	Packaging contained the incorrect size of femoral head from what was displayed on the label.	accessdata.fda.gov
August 31, 2023	92976	Class II	Ongoing	smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint	The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.	accessdata.fda.gov
April 19, 2022	90078	Class II	Terminated	LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5	It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.	accessdata.fda.gov

Compare with other makers

Updated October 31, 2024. 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.