Data / Medical devices / France / Biomet France

Biomet France: FDA-registered device maker in Valence Drome, France, 43 510(k) clearances and 1 PMA approval

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

Biomet France is registered with the FDA (registration 3006946279) in Valence Drome, France. It lists 36 device types. The FDA files 43 510(k) clearances and 1 PMA approval under its listings, the newest dated April 15, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3006946279
Address: Plateau de Lautagne, Valence Drome, France, 26000
Owner or operator: Zimmer Inc (1825034)
Roles: Contract manufacturer, Manufacturer
First device listed: December 28, 1977
Registered through: 2027
Brand names listed: 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5, 6.5MM SOLID CANCELLOUS BONE SCREW, 824677021, 22, 824071001, 824071101, 824671001, 82467, A. L. P. S. Clavicle Plating System, ACE 3.5MM CORTICAL BONE SCREW, ACE AIM TTC FUSION NAIL, ACE BROOKER BONE PLATING SYSTEM, ACE CANCELLOUS BONE SCREW and more

Devices it lists

Device	Product code	Class	Role	Source
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
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Bone Cement	LOD	2	Manufacturer	accessdata.fda.gov
Bone Cement, Antibiotic	MBB	2	Manufacturer	accessdata.fda.gov
Bone Grafting Material, Synthetic	LYC	2	Contract manufacturer	accessdata.fda.gov
Component, Traction, Invasive	JEC	2	Manufacturer	accessdata.fda.gov
Dispenser, Cement	KIH	1	Manufacturer	accessdata.fda.gov
Forceps, Wire Holding	HYA	1	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	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
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	MAY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	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 Cemented Acetabular Component)	JDL	3	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	KWA	3	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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing	NRA	3	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Starter, Bone Screw	HWD	1	Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Washer, Bolt Nut	HTN	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
April 15, 2026	K254107	Refobacin Bone Cement R (110034355)	LOD	Substantially Equivalent	Biomet France	accessdata.fda.gov
April 6, 2018	K173767	A. L. P. S. Clavicle Plating System	HRS	Substantially Equivalent	Biomet, Inc.	accessdata.fda.gov
October 5, 2017	K172408	Biomet Bone Cement R	LOD	Substantially Equivalent	Biomet, Inc.	accessdata.fda.gov
August 30, 2017	K171540	Refobacin Bone Cement R	LOD	Substantially Equivalent	Biomet, Inc.	accessdata.fda.gov
March 30, 2015	K143697	Biomet Proximal Humerus Plating System	HRS	Substantially Equivalent	Biomet Manufacturing	accessdata.fda.gov
March 12, 2012	K111663	TRAUMA INTERNAL FIXATION SYSTEMS	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
June 22, 2011	K111444	UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION	HSB	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
December 7, 2010	K100469	ARCOS INTERLOCKING DISTAL STEMS	KWA	Substantially Equivalent	Biomet Manufacturing Corp	accessdata.fda.gov
July 23, 2010	K101240	CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
May 11, 2010	K100238	HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM	HSB	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
March 20, 2009	K083843	LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
February 18, 2009	K082300	ANATOMIC LOCKING PLATING SYSTEM	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
August 26, 2008	K081546	SMALL BONE LOCKING PLATING SYSTEM	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
December 14, 2007	K072832	ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
November 7, 2007	K072423	4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
October 25, 2007	K072083	SMALL FRAGMENT LOCKING PLATING SYSTEM	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
October 19, 2006	K062352	FRS SCREW	HWC	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
May 12, 2006	K060969	POLYAX LOCKED PLATING SYSTEM	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
September 8, 2004	K042325	TROCHANTERIC NAIL SYSTEM	HSB	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
December 15, 2000	K003797	ACE AIM TTC FUSION NAIL	HSB	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
November 6, 2000	K003235	PE.R.I. II KNEE FRACTURE SYSTEM	HRS	Substantially Equivalent	DePuy Orthopaedics, Inc.	accessdata.fda.gov
February 1, 1999	K990120	MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE	HSB	Substantially Equivalent	Depuy Ace Medical Co.	accessdata.fda.gov
December 22, 1998	K983853	DEPUY ACE TIMAX META PLATE	HRS	Substantially Equivalent	Depuy Ace Medical Co.	accessdata.fda.gov
March 10, 1998	K974781	DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL	HSB	Substantially Equivalent	Depuy, Inc.	accessdata.fda.gov
October 9, 1997	K972629	DEPUY AE TK2 HIP SCREW SYSTEM	KTT	Substantially Equivalent	Depuy, Inc.	accessdata.fda.gov
August 26, 1997	K972183	DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL	HSB	Substantially Equivalent	Ace Medical Co.	accessdata.fda.gov
July 9, 1997	K971069	TWIST-OFF (TM) SCREW	HWC	Substantially Equivalent	Landos, Inc.	accessdata.fda.gov
October 3, 1996	K962233	TWIST-OFF SCREW	HWC	Substantially Equivalent	Landos, Inc.	accessdata.fda.gov
April 1, 1996	K955472	ACE HUMERUS & RADIUS PLATES	HRS	Substantially Equivalent	Ace Medical Co.	accessdata.fda.gov
October 31, 1995	K954485	6.5MM SOLID CANCELLOUS BONE SCREW	HWC	Substantially Equivalent	Ace Medical Co.	accessdata.fda.gov
September 1, 1994	K931155	STAPLE, FIXATION BONE; SCREW FIXATION BONE	HWC	Substantially Equivalent	Roseburg SA	accessdata.fda.gov
March 22, 1994	K934962	AIM SUPRACONDYLAR NAIL	HSB	Substantially Equivalent	Ace Orthopedic Manufacturing Co.	accessdata.fda.gov
November 27, 1991	K912598	ACE CORTICAL BONE SCREW	HWC	Substantially Equivalent for Some Indications	Ace Medical Co.	accessdata.fda.gov
November 21, 1991	K914858	ACE OPEN-BACK HALO RING	JEC	Substantially Equivalent	Ace Medical Co.	accessdata.fda.gov
March 14, 1991	K905595	ACE RECONSTRUCTIVE PLATE	HRS	Substantially Equivalent	Ace Medical Co.	accessdata.fda.gov
January 30, 1991	K905048	ACE 3.5MM CORTICAL BONE SCREW	HWC	Substantially Equivalent	Ace Medical Co.	accessdata.fda.gov
October 16, 1990	K903810	ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW	HWC	Substantially Equivalent for Some Indications	Ace Medical Co.	accessdata.fda.gov
June 22, 1989	K892214	REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW	HWC	Substantially Equivalent	Ace Medical Co.	accessdata.fda.gov
August 1, 1988	K882831	ACE CANCELLOUS BONE SCREW	HWC	Substantially Equivalent	Buckman Co., Inc.	accessdata.fda.gov
August 17, 1987	K872859	ACE CANCELLOUS BONE SCREW	HWC	Substantially Equivalent	Ace Medical Co.	accessdata.fda.gov
August 17, 1987	K871539	ZINDRICK IM ROD	HSB	Substantially Equivalent	Buckman Co., Inc.	accessdata.fda.gov
December 12, 1983	K833865	ACE BROOKER BONE PLATING SYSTEM	HRS	Substantially Equivalent	Buckman Co., Inc.	accessdata.fda.gov
January 10, 1979	K782123	MULTIPLICITY OF PRODUCTS	HRS	Substantially Equivalent	Depuy, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
April 21, 2004	P010014	OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM	NRA	107	October 6, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 21, 2016	73141	Class II	Terminated	Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograft Granules, Bone Grafting Material, Synthetic are used in the following dental and/o	Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.	accessdata.fda.gov
May 14, 2015	71365	Class II	Terminated	The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.	The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.	accessdata.fda.gov

Compare with other makers

Updated October 6, 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.