Is this your brand? Sign in to claim ownership.

Rti Surgical, Inc.

Last updated May 24, 2026

What Rti Surgical, Inc. makes

RTI Surgical, Inc. manufactures spinal interbody fusion cages made from polymeric materials, orthopaedic fixation systems and associated surgical kits, reusable implant templates, and human-derived bone matrix implants. Their portfolio includes orthopaedic tools such as reusable inserters, trial-implant holders, bone curettes, and power tool attachments for drilling. They also supply meniscus allografts for transplantation and lateral plate systems for spinal or joint stabilization.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are regulated under U.S. medical device laws, with specific authorisation requirements depending on the device class. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: resolvesurg.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(906)226-9909
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 117560455

Catalogue (1081)

Page 22 of 22

Device	Model / Reference	Registries	Class	Status
MaxFuse PEEK VBR SYSTEM	724-901	FDA UDI	Class I	Active
OPTEFORM® Allograft Paste, 5cc	005105	FDA UDI	Class II	Active
C-Plus PEEK IBF System	724-314	FDA UDI	Class I	Active
C-Plus PEEK IBF System	723-635	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1840-9-12L	FDA UDI	Class II	Active
MaxFuse PEEK VBR SYSTEM	724-900	FDA UDI	Class I	Active
C-Plus PEEK IBF System	724-743	FDA UDI	Class I	Active
BioSet®	008850	FDA UDI	Class II	Active
Precision Allograft Cartilage Kit (PACK™)	PAC-A2014	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1865-13-12L	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-2255-11	FDA UDI	Class II	Active
Precision Allograft Cartilage Kit (PACK™)	437-130	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-1445-9	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-2245-15-12L	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-2645-9	FDA UDI	Class II	Active
Fusion Lateral Instrument Set	723-547	FDA UDI	Class I	Active
Cross-Fuse® II PEEK IBF System	38-2650-15	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-2660-17-6L	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-1840-9-6C	FDA UDI	Class II	Active
Cross-Fuse® II PEEK IBF System	38-1860-13-18L	FDA UDI	Class II	Active
C-Plus PEEK IBF System	724-727	FDA UDI	Class I	Active
MaxFuse PEEK VBR SYSTEM	724-432	FDA UDI	Class I	Active
Cross-Fuse II PEEK IBF System	724-421	FDA UDI	Class I	Active
C-Plus PEEK IBF System	723-631	FDA UDI	Class I	Active
Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )	K230036	FDA 510(k)	Class II	Active
Bovine Pericardium Suturable Dural Graft, Tutopatch Dm Graft, Tutoplast Bovine Pericardium Dm	K132850	FDA 510(k)	Class II	Active
Fortilink™-C with TETRAfuse™ 3D Technology	K163673	FDA 510(k)	Class II	Active
Pre-Sutured Tendon	K253145	FDA 510(k)	Class II	Active
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC	K241555	FDA 510(k)	Class II	Active
Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology	K172343	FDA 510(k)	Class II	Active
Fortiva Porcine Dermis, Tutoplast Porcine Dermis	K142070	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

RTI Surgical, Inc. has three recall records initiated between October 7, 2013, and January 23, 2017, all of which are recorded as terminated. The recalls involved documentation errors for the 10 mm x 12 mm Webless C-Plus implants, a potential mislabeling of the OPTEFORM Allograft Paste 5cc packaging (including an incorrect fluid fill line), and incorrect instructions for use for an unspecified product.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jan 23, 2017	Z-1441-2017	—	terminated	Incorrect instructions for use (IFU) included.
Dec 6, 2013	Z-0939-2014	—	terminated	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.
Oct 7, 2013	Z-0627-2014	—	terminated	As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a s