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A curated portfolio of FDA-regulated and 510(k)-cleared regenerative medicine products — distributed by a team that operates its own regenerative medicine and wound care clinic in Westerville, Ohio.
From human tissue allografts and autologous biologics to hyaluronic acid viscosupplementation — Hawk Medical serves as your single distribution partner across the full orthobiologics spectrum, with comprehensive compliance and practice integration support included.
Not a sales call. A conversation with a fellow practice owner.
The orthobiologics landscape gives practices powerful tools for musculoskeletal care — but navigating product options, regulatory classifications, and multiple vendor relationships creates operational complexity that gets in the way of using those tools effectively.
Hawk Medical serves as your single distribution partner across the full orthobiologics and regenerative medicine spectrum. We align exclusively with manufacturers who meet strict regulatory, quality, and clinical standards — so the products reaching your practice have already cleared a rigorous evaluation process before they reach your patients.
Every product operates under the appropriate FDA regulatory pathway. Tissue allografts regulated under 21 CFR Part 1271. PRP and injectable systems carry 510(k) clearance.
All human tissue allografts sourced exclusively from AATB-accredited tissue banks and processed under cGMP and CLIA-certified standards.
Tissue allografts, PRP systems, BMAC, A2M concentrate, adipose allografts, and HA injectables under a single distribution relationship with one point of contact.
Regulatory documentation frameworks, coding education, workflow integration, and staff training included with every partner relationship — not a separate service.
Every product in our portfolio is sourced from vetted manufacturers, operates under the appropriate FDA regulatory pathway, and is used in our own clinical practice. Specific manufacturer names and pricing are discussed during consultation.
Our human tissue allografts are minimally manipulated, DMSO-free products derived from ethically donated human birth tissue. Processed to preserve naturally occurring structural components, these allografts support musculoskeletal repair and restoration across joints, soft tissue, tendons, and ligaments.
Classified under 21 CFR Part 1271 for homologous structural use — not a drug product, not a stem cell therapy, and not FDA-approved or FDA-cleared through a drug or device pathway.
These structural tissues contain naturally occurring extracellular matrix components — including collagen types I, III, and IV, hyaluronic acid, elastin, fibronectin, glycosaminoglycans, and acid mucopolysaccharides — that support the body's own structural repair processes at the site of injury or degeneration.
May reduce mechanical impact on compromised joints and soft tissue, supporting the body's natural repair processes without synthetic additives. Cushioning function may help protect surrounding nerves, cartilage, and connective structures from ongoing mechanical stress.
Provides structural support in areas where connective tissue is thin, degenerated, or compromised — including tendons, ligaments, and joint-adjacent soft tissue. May help maintain normal tissue spacing and reduce localized pressure during load-bearing activity.
Supports joint and tissue integrity by addressing loss of elasticity and compression resistance. May help affected joints and soft tissue return to a more natural functional range of motion, with improved shock absorption for daily and athletic activity.
Every human tissue allograft in the Hawk Medical portfolio is sourced from tissue banks that meet or exceed the following standards — non-negotiable requirements across every product we carry.
Manufactured in an FDA-registered establishment operating under current Good Manufacturing Practice (cGMP) standards.
Tissue bank holds accreditation from the American Association of Tissue Banks — the highest voluntary quality standard in the tissue banking industry.
Bio-ethically donated by healthy, consenting U.S. mothers following full-term, live, C-section births — with comprehensive medical screening on every donor.
Every lot independently tested for sterility, endotoxin, and environmental compliance by accredited third-party laboratories — exceeding standard industry requirements.
Processed under 21 CFR Part 1271 guidelines to preserve the tissue’s original relevant structural and biological characteristics.
Preserved without DMSO or synthetic cryoprotectant additives using proprietary methods that maintain tissue integrity through delivery.
Not a sales call. A conversation with a fellow practice owner.
Human tissue allografts distributed by Hawk Medical are regulated as 361 HCT/Ps under 21 CFR Part 1271 and are not FDA-approved or FDA-cleared. No medical claims regarding treatment, cure, or prevention of any disease or condition are made or implied. All structural tissue characteristics described reflect the naturally occurring properties of the human birth tissue from which these products are derived. Physicians are responsible for determining appropriate patient selection, treatment protocols, and regulatory compliance.
Orthobiologics and regenerative medicine products span multiple FDA regulatory pathways. Knowing which pathway applies to which product directly affects clinical documentation, patient disclosure, and how your practice responds to payer or regulatory inquiries.
Regulated under 21 CFR Part 1271 as minimally manipulated human tissue for homologous structural use. FDA regulated — not approved through a drug or device pathway. AATB accreditation and cGMP processing are the relevant quality standards.
PRP centrifuge platforms and HA injectable systems carry FDA clearance through the 510(k) pathway — demonstrating substantial equivalence to legally marketed predicate devices. Clearance is distinct from approval and indicates FDA review of device safety and effectiveness for its intended use.
Hyaluronic acid viscosupplementation products in our portfolio carry full FDA approval — available by prescription only and reimbursable under Medicare and major commercial payers.
PRP, BMAC, and A2M concentrate use the patient's own biological material, placing them outside the tissue allograft regulatory framework. Compliance centers on device clearance for preparation systems and appropriate documentation of autologous use.
A 15-minute conversation about your specialty, patient population, and current product relationships. We identify which categories are most relevant and whether a single distribution relationship makes operational sense for your practice.
Before your first order we walk through the regulatory classification of every product you will carry, the documentation framework for clinical use, and appropriate patient disclosure language for each product category.
Product delivery coordinated with staff orientation, SOP development, and workflow integration — so your first patient experience with these products is confident and well-documented.
One point of contact. Responsive by phone and text. Proactive on regulatory updates, new product additions, and payer policy changes affecting your orthobiologics program.
Schedule a confidential 15-minute call. We'll walk through the products most relevant to your specialty and patient population — with no obligation and no pressure to move forward until you're ready.
Not a sales call. A conversation with a fellow practice owner.
All products distributed by Hawk Medical operate under appropriate FDA regulatory pathways and are used in accordance with approved labeling and intended use. Hawk Medical does not make medical claims beyond what is supported by product labeling and published clinical evidence. Physicians are responsible for determining appropriate patient selection, treatment protocols, and compliance with all applicable regulations. Specific manufacturer names and product specifications are provided during confidential consultation.