BETA
Hummelstown, Pennsylvania orthopedic-device company commercializing implants and instruments for minimally invasive forefoot surgery, led by OptimalMTP joint fusion.
Forma Medical is a privately held orthopedic-device company founded in 2021. Its current office is in Hummelstown, Pennsylvania, and its co-founder Andrew C. Davison serves as chairman, president and CEO. Its commercial model combines implants, instruments and surgeon education for minimally invasive forefoot procedures.
The portfolio includes OptimalMTP for first-MTP joint fusion, OptimalTMT for Lapidus/TMT fusion, OptimalAkin for Akin osteotomy and OptimalHT for hammertoe correction. Two FDA 510(k) decisions cover the Optimal Plating System and headless compression screws; these are device-family authorizations, not four separate branded-procedure clearances.
In January 2026, Forma announced a sharper focus on OptimalMTP and reported use in more than 650 patients. Ben Franklin Technology Partners confirms investment and business support, but a verified total funding amount and annual revenue remain unconfirmed. Published technique literature and general biomechanical evidence do not establish comparative clinical superiority of the full commercial procedure.
K230945 July 18, 2023: HWC headless compression screws. K234059 June 26, 2024: HRS/HWC Optimal Plating System. Clearance is not approval of superiority claims or every MIS protocol. [15][16][1][17][19][5][4][21][23][3]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [10][7]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Plate-and-screw system and instruments for first metatarsophalangeal arthrodesis. Device clearance is distinct from validation of every procedural or recovery claim. [23][16]
FDA-clearedCommercially marketed to surgical practices; confirm model availability and training with Forma.
Marketed instrument-guided system for TMT fusion, introduced in limited release in March 2025. Company describes use of its Optimal plating technology. [24][16]
FDA-clearedCommercially marketed to surgical practices; confirm model availability and training with Forma.
Implant and instrument kit for Akin osteotomy fixation. A representative targeting-instrument listing links the brand to the cleared headless compression screw system. [24][15][1]
FDA-clearedCommercially marketed to surgical practices; confirm model availability and training with Forma.
Instrument-guided system marketed for hammertoe correction. Exact current implant and accessory models require labeling-level regulatory mapping. [24]
Marketed · regulatory scope variesCommercially marketed to surgical practices; confirm model availability and training with Forma.
Current growth focus is OptimalMTP; company reports 650+ patients as of January 2026. Surgeon education and technique publications support procedural understanding, with independent comparative outcomes still requiring review. [20][24][14][12]
Company prioritized OptimalMTP, reported over 650 treated patients, announced methods patent 12,521,157 and appointed Aaron Smith. Patient count is company-reported use, not an independently audited efficacy outcome. [20]
Company expanded its MIS portfolio with a Lapidus plating offering. [19]
FDA issued K234059; company announcement followed July 9. [16]
Company reported completion of its initial 15-patient limited release and transition to broader commercialization. [18]
Accessed 10/29/2026