GraftGun ↗
Universal graft delivery platform for delivery into surgical sites and cages. [92]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.

Privately held manufacturer of spine and orthopedic implants, graft materials and surgical instruments.
SurGenTec is a privately held medical device company based in Boca Raton, Florida. Its company history dates its founding by Travis Greenhalgh to 2016. The current portfolio spans facet fixation, sacroiliac joint fusion, synthetic bone grafts, allografts, graft-delivery instruments and surgical access tools. Flagship families include ION, TiLink, OsteoFlo and GraftGun.
The company markets products to spine and orthopedic surgeons and works through distribution relationships. Recent activity includes cervical and lumbar facet fixation clearances and navigation-compatible instruments. In October 2026, it announced an exclusive license for Allevion Medical's Vantage lumbar decompression technology, now listed in SurGenTec's portfolio. That FDA clearance predates the license and remains attributed to Allevion; compatibility with another manufacturer's navigation platform is not itself evidence of a corporate partnership.
Evidence varies across products. Published HydroFiber research includes a rabbit fusion model, while a manufacturer GraftRasp white paper describes three clinical cases and company announcements describe ION-C clinical follow-up. These sources should not be combined into a broad claim of human clinical superiority. FDA-cleared uses remain device-specific. Public revenue, funding-round totals, audited customer counts and confirmed payer coverage were not established in this review.
The reviewed portfolio contains 510(k)-cleared devices and graft products with different regulatory bases. ION facet fixation records include FDA's unclassified device category, which is distinct from a recall hazard class. Allograft catalog listings do not automatically establish clearance, approval or exemption. Exact labeled uses and concurrent-device requirements govern each device. [75][85][89][5][4][103][95][3]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [48][42]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Universal graft delivery platform for delivery into surgical sites and cages. [92]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Instrument family for decortication and graft delivery; not counted as a separate graft material. [94]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Access needle and bone marrow aspiration kit family; neuro-access and BMA variants have separate FDA decisions. [91]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Facet screw platform; bone-integration marketing includes animal evidence and should not be treated as human outcomes. [99]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Temporary adjunct stabilization for posterior cervical fusion. K251714 limits use to revision anterior pseudoarthrosis at one or two contiguous levels C3-C7, bilaterally, with FDA-cleared anterior plate and interbody device at the same levels. [97]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
SI joint fusion family including separately cleared navigation instruments. [104]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Posterior SI joint fusion family and surgery-ready kit offering; packaging variants do not automatically add authorizations. [103]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Quadphasic synthetic bone graft family. [96]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Hydrophilic synthetic bone graft family. [102]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Fiber-containing synthetic bone void filler; FDA labeling and clinical evidence are distinct. Rabbit fusion results do not establish equivalent human outcomes. [101]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Allograft family listed by the company. Supplier/tissue regulatory mapping remains incomplete; do not infer a 510(k) clearance from a portfolio listing. [95]
Marketed · regulatory scope variesListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Viable fiber and fiber matrix offerings. Company historical timeline references an Aziyo relationship; current processor and regulatory pathway require confirmation. [106]
Marketed · regulatory scope variesListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Current catalog offering; detailed regulatory mapping remains incomplete. [93]
Marketed · regulatory scope variesListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Sterile, single-use decompression instruments licensed from Allevion Medical. FDA K252546 predates the SurGenTec license; this is a license, not an acquisition. [105][88]
FDA-clearedListed in current company portfolio; exact model availability should be confirmed with the manufacturer.
Current research and recent regulatory expansions are tracked in the timeline. Durashield has an FDA clearance but its commercial status was not confirmed, so it is excluded from the marketed scorecard; clearance alone does not establish a launch or an active commercial-development program. [100]
SurGenTec announced an exclusive technology license with Allevion Medical. Vantage is listed in its current portfolio; K252546 retains Allevion as original FDA applicant. [88]
FDA cleared K261209 for Ion-L; navigated instruments have a separate decision, K262121 dated July 24, 2026. [79]
A peer-reviewed rabbit posterolateral fusion study compared HydroFiber and autograft through 12 weeks. These preclinical findings are not a human noninferiority trial. [50]
FDA decision K253604. The company's April announcement describes StealthStation compatibility; compatibility alone is not proof of a corporate Medtronic partnership. [77]
FDA K251714 covers defined cervical revision pseudoarthrosis uses, with bilateral implantation and specified concurrent cleared devices. It is not unrestricted stand-alone cervical fixation. [74]
FDA cleared K200431; a later 2020 decision also appears in the family's authorization history. [55]
FDA cleared K170675 for the Graftgun Universal Graft Delivery System. The company timeline separately reports market launch in 2017. [51]
The company history timeline identifies 2016 as SurGenTec's founding by Travis Greenhalgh in Boca Raton. [108]
Accessed 10/20/2026