Data / Medical devices / United States / RTI Surgical, Inc. (dba RTI Biologics, Inc.)

RTI Surgical, Inc. (dba RTI Biologics, Inc.): FDA-registered device maker in Alachua, FL, United States, 17 510(k) clearances

Name: RTI Surgical, Inc. (dba RTI Biologics, Inc.) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

RTI Surgical, Inc. (dba RTI Biologics, Inc.) is registered with the FDA (registration 3002719998) in Alachua, FL, United States. It lists 33 device types. The FDA files 17 510(k) clearances under its listings, the newest dated October 22, 2025. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002719998
Address: 11621 Research Circle, Alachua, FL, United States, 32615
Owner or operator: RTI Surgical, Inc. (dba RTI Biologics, Inc.) (1641375)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: July 23, 2008
Registered through: 2026
Brand names listed: - Plug Station, - Ruler, for estimating size, - Steinman Pin/K-Wire, used as a guide, - Surgical Bit, - Vise, -Base Plate, component of coring station, -Carriage break, component of coring station, -Carriage, component of coring station and more

Devices it lists

Device	Product code	Class	Role	Source
Barrier, Animal Source, Intraoral	NPL	2	Specification developer	accessdata.fda.gov
Bit, Drill	HTW	1	Specification developer	accessdata.fda.gov
Bit, Surgical	GFG	1	Specification developer	accessdata.fda.gov
Bone Grafting Material, Human Source	NUN	2	Manufacturer	accessdata.fda.gov
Brace, Drill	HXY	1	Specification developer	accessdata.fda.gov
Clamp	HXD	1	Specification developer	accessdata.fda.gov
Cutter, Surgical	FZT	1	Specification developer	accessdata.fda.gov
Dura Substitute	GXQ	2	Specification developer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Manufacturer	accessdata.fda.gov
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	MBP	2	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Specification developer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Specification developer	accessdata.fda.gov
Mallet	HXL	1	Specification developer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Specification developer	accessdata.fda.gov
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery	OXF	2	Specification developer	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Specification developer	accessdata.fda.gov
Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	PAJ	2	Specification developer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Specification developer	accessdata.fda.gov
Osteotome, Manual	GFI	1	Specification developer	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Specification developer	accessdata.fda.gov
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	DXZ	2	Specification developer	accessdata.fda.gov
Rasp	HTR	1	Specification developer	accessdata.fda.gov
Reamer	HTO	1	Specification developer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Spatula, Surgical, General & Plastic Surgery	GAF	1	Repackager or relabeler	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Manufacturer	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Repackager or relabeler	accessdata.fda.gov
Tamp	HXG	1	Specification developer	accessdata.fda.gov
Tap, Bone	HWX	1	Specification developer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Specification developer	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 22, 2025	K253145	Pre-Sutured Tendon	GAT	Substantially Equivalent	Rti Surgical, Inc.	accessdata.fda.gov
June 23, 2023	K230036	Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )	GAT	Substantially Equivalent	Rti Surgical, Inc.	accessdata.fda.gov
October 27, 2014	K142070	FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS	FTM	Substantially Equivalent	Rti Surgical, Inc.	accessdata.fda.gov
March 31, 2014	K132850	BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM	GXQ	Substantially Equivalent	Rti Surgical, Inc.	accessdata.fda.gov
March 5, 2013	K123356	FORTIVA PORCINE DERMIS	FTM	Substantially Equivalent	Rti Biologics, Inc.	accessdata.fda.gov
June 19, 2008	K081538	TUTOPATCH, TUTOMESH	FTM	Substantially Equivalent	Rti Biologics, Inc.	accessdata.fda.gov
May 12, 2008	K073097	TUTODENT DENTAL MEMBRANE	NPL	Substantially Equivalent	Tutogen Medical U.S., Inc.	accessdata.fda.gov
April 30, 2008	K080418	REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST	NUN	Substantially Equivalent	Regeneration Technologies, Inc.	accessdata.fda.gov
October 24, 2007	K072327	CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON	MQV	Substantially Equivalent	Regeneration Technologies, Inc.	accessdata.fda.gov
May 9, 2007	K063584	STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937	HWC	Substantially Equivalent	Regeneration Technologies, Inc.	accessdata.fda.gov
September 6, 2006	K060180	BIOSET XC	MBP	Substantially Equivalent	Regeneration Technologies, Inc.	accessdata.fda.gov
February 23, 2006	K060253	STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.	HWC	Substantially Equivalent	Regeneration Technologies, Inc.	accessdata.fda.gov
November 16, 2005	K052405	STERLING INTERFERENC SCREW HT	HWC	Substantially Equivalent	Regeneration Technologies, Inc.	accessdata.fda.gov
August 15, 2005	K051615	STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES	MQV	Substantially Equivalent	Regeneration Technologies, Inc.	accessdata.fda.gov
June 9, 2005	K050767	STERLING INTERFERENCE SCREW ST	HWC	Substantially Equivalent	Regeneration Technologies, Inc.	accessdata.fda.gov
February 16, 2005	K043421	OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC	MQV	Substantially Equivalent	Regeneration Technologies, Inc.	accessdata.fda.gov
February 10, 2005	K043420	OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE	MQV	Substantially Equivalent	Regeneration Technologies, 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
January 23, 2017	76473	Class II	Terminated	RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications	Incorrect instructions for use (IFU) included.	accessdata.fda.gov
December 6, 2013	67246	Class II	Terminated	REF 606-01-05*OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.STERILE Using Radiation. Rx Only*Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 326	RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.	accessdata.fda.gov
April 9, 2011	58887	Not yet classified	Terminated	Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615*Distributed by: SpinalGraft Technologies, LLC 4340 Swinnea Road STE 39 Memphis, TN 38118*OSTEOFIL DBM Paste, 5cc Tissue ID: 321933 Reorder: 002405	RTI Biologics issued a recall of Osteofil DBM Paste, 5cc that was distributed on 03/04/2008 to one customer. The product was labeled as 5.0cc but should have been labeled as 0.5cc. All customers were notified of this recall on 04/09/2011.	accessdata.fda.gov
October 14, 2005	34367	Not yet classified	Terminated	Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''*Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USASINGLE PATIENT USE ONLY**''.	The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tiss	accessdata.fda.gov
October 14, 2005	34004	Not yet classified	Terminated	Product is 1.0 cc Regenaform RT. Product is labeled in part: ''*Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USASINGLE PATIENT USE ONLY**''.	The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tiss	accessdata.fda.gov

Compare with other makers

Updated October 22, 2025. 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.