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Scottsdale-based spine implant company developing and commercializing lateral fusion, partial vertebral-body replacement, and navigated surgical instruments.
Foundation Surgical is a privately held spine implant company founded in 2021 and headquartered in Scottsdale, Arizona. Founded and led by spine surgeon Randal Betz, MD, it focuses on lateral spine surgery and motion-preservation technology.
Its portfolio includes the Interwedge Standalone Lateral fusion system, Vertiwedge Intraosseous System, and navigated disc-preparation instruments. The company promotes LLIF180 and Vertebral Body Osteotomy (VBO) as procedural workflows associated with these devices. FDA records document five 510(k) decisions across three product families.
Commercialization remains early: the company announced its first Interwedge case at Reading Hospital in September 2025 and a selective alpha launch, followed by additional company-reported surgical use. Its financing history includes a 2023 SEC filing reporting US$1 million sold in a convertible-note offering. Current revenue and the scale of clinical adoption are not established.
Three Class II families: Interwedge (OVD; initial decision also MAX), Vertiwedge (MQP), and navigated instruments (OLO). FDA indications govern device use; procedural marketing and outcome claims require separate appraisal. [1][2][10][11][12][16][17][18][19][22]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [24][25]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Lateral fusion implant with integrated fixation and deployable contralateral staple, used in the company’s LLIF180 workflow. [11][19]
FDA-clearedU.S. early commercial use; first case and selective alpha launch announced September 2025.
Intraosseous implant used in the company’s motion-preserving VBO procedure; the cleared device indication is summarized separately from procedural benefit claims. [12][18]
FDA-clearedU.S. cleared; company reports an initial VBO case and short-term follow-up. Breadth of launch is not established.
Disc-preparation instruments and trials designed for compatibility with Medtronic StealthStation S8 navigation. Compatibility is not evidence of an exclusive partnership. [10][3]
FDA-clearedCompany markets the cleared instrument platform; specific shipped volumes and customer coverage are not established.
Early rollout includes surgeon training and distribution development. Company-reported first-case outcomes are preliminary; independent comparative clinical evidence and long-term follow-up require further review. [21][6]
FDA issued K261809 and K261810 for the two existing implant families. These add decisions, not two additional product families. [11][12]
K260011 covers navigated disc-preparation instruments designed for StealthStation S8 use. [10]
Company named Dr. Edward DelSole at Reading Hospital, Tower Health, and described selective U.S. alpha launch activity. This is company-reported adoption, not an independent outcomes study. [21]
K241468 cleared the partial vertebral-body replacement system for its specified indications. [2]
K241487 cleared the standalone lateral lumbar interbody fusion system. [1]
Amended Form D reports US$1M sold in an offering targeting US$3M. This is an issuer-reported financing snapshot, not current revenue or total lifetime funding. [28]
Founded in 2021 according to LinkedIn; SEC filing confirms 2021 incorporation and former name NOFUSCO Corp. [28]
Accessed 10/29/2026