Understanding allografts
What allograft tissue is, how it’s regulated, and where the line on “homologous use” actually sits.
Last updated: July 2026
An allograft is human tissue donated by one person and transplanted into another — distinct from an autograft (tissue moved within the same patient) and a xenograft (tissue from another species). Allografts are used across orthopedic, dental, reconstructive, and sports medicine procedures to repair, reconstruct, or supplement a recipient’s own tissue.
In the United States, most allografts are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps) under FDA 21 CFR Part 1271, rather than as licensed biologics. To qualify for that lighter-touch pathway, a tissue must be minimally manipulated and intended solely for homologous use — meaning it performs the same basic function in the recipient as it did in the donor. A heart valve replacing a diseased heart valve is homologous use; the same tissue repurposed for an unrelated function would not be.
That distinction is why every graft in our catalog is labeled and marketed strictly for its homologous function, and why the documentation trail — from donor screening through final distribution — matters as much as the tissue itself.
Sources
FDA — Regulatory Considerations for HCT/Ps: Minimal Manipulation and Homologous Use · eCFR 21 CFR Part 1271