Data / Medical devices / United Kingdom / Implants Intl. Ltd.

Implants Intl. Ltd.: FDA-registered device maker in THORNABY-ON-TEES Stockton-on-Tees, United Kingdom, 11 510(k) clearances

Name: Implants Intl. Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Implants Intl. Ltd. is registered with the FDA (registration 1000547811) in THORNABY-ON-TEES Stockton-on-Tees, United Kingdom. It lists 10 device types. The FDA files 11 510(k) clearances under its listings, the newest dated February 7, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1000547811
Address: 71 Jay Ave. Teesside Industrial Est., THORNABY-ON-TEES Stockton-on-Tees, United Kingdom, T517 9LZ
Owner or operator: IMPLANTS INTL. LTD. (9046526)
Roles: Contract manufacturer, Manufacturer
First device listed: June 13, 2001
Registered through: 2026
Brand names listed: CL Stem Stability Hip, Cer-Met III Cup, Omni-Fix Femoral and Tibial Nail, Omni-Fix IM Humeral Nail, Performa C-Fit Hip, Peri-articular Forceps, Regi-Fix Hip, Rim-Fix Cup and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	KTW	2	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Contract 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, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained	JWI	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
February 7, 2014	K132539	RING-LOK MODULAR BIPOLAR SYSTEM	KWY	Substantially Equivalent	Implants International, Ltd.	accessdata.fda.gov
November 19, 2007	K072101	RIGI-FIX HIP STEM SYSTEM	LPH	Substantially Equivalent	Implants Intl. , Ltd.	accessdata.fda.gov
July 25, 2007	K071583	CERMET III ACETABULAR CUP SYSTEM	MEH	Substantially Equivalent	Implants International, Ltd.	accessdata.fda.gov
January 28, 2000	K993713	RIM-FIX, ACETABULAR CUP	JDI	Substantially Equivalent	Surgical Implants, Inc.	accessdata.fda.gov
June 29, 1999	K991405	OMNI-FIX, HUMERAL NAIL	KTW	Substantially Equivalent	Turnkey Intergration USA, Inc.	accessdata.fda.gov
April 1, 1999	K990307	OMNI-FIX, NAIL SYSTEM	KTW	Substantially Equivalent	Turnkey Intergration USA, Inc.	accessdata.fda.gov
November 6, 1998	K980999	ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT	JWH	Substantially Equivalent	Instrument Makar, Inc.	accessdata.fda.gov
February 6, 1995	K940297	UNIVERSAL WRIST	JWI	Substantially Equivalent for Some Indications	Turnkey Intergration USA, Inc.	accessdata.fda.gov
April 5, 1994	K922613	CL HIP STEM H/A COATED	MEH	Substantially Equivalent for Some Indications	Lima Intl. Corp.	accessdata.fda.gov
November 4, 1992	K923898	C-FIT CEMENTED HIP STEM	JDI	Substantially Equivalent	Turnkey Intergration USA, Inc.	accessdata.fda.gov
June 14, 1991	K910836	LIMA COLLARED CL STEM	JDI	Substantially Equivalent	Lima Intl. Corp.	accessdata.fda.gov

Compare with other makers

Updated February 7, 2014. 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.