Lincoln
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
43- Orthopaedic Surgery
- 43
How orthopedic groups qualify a biologics distributor
Orthopedic groups and ambulatory surgery centers typically run new tissue and biologics vendors through a compliance or risk committee before any product reaches a shelf. That review usually starts with a request for the supplier's HCT/P processing description, a certificate of analysis for the specific lot, a donor eligibility summary, and a lot release record.
Because Wharton's jelly allografts are regulated as human cells, tissues, and cellular and tissue-based products, many committees also ask whether a given intended use is expected to qualify under 21 CFR 1271.10's minimal manipulation and homologous use criteria. That determination belongs to the practice and its own counsel, not to the supplier.
- Certificate of analysis for the specific lot
- Donor eligibility and screening summary
- Lot release and sterility testing record
- Registration and licensure documentation on request
NPI-verified accounts and ordering
Precision Biologics opens accounts only for licensed physicians and the practices and surgery centers they direct. Setting up an account requires a valid NPI number, which the public registry at npiregistry.cms.hhs.gov can confirm independently of anything we provide.
Pricing is not published and is shared only with verified accounts once that step is complete.
Shipping and cold-chain handling for Nebraska orders
Cryopreserved Wharton's jelly and exosome formats are held in slow-rate frozen storage at -80 degrees Celsius and ship overnight on dry ice in validated containers. Lyophilized formats are shelf-stable and do not require that cold chain, but still arrive with the lot's own documentation.
A receiving practice should have a process for logging the lot number against the shipment and confirming the container held temperature in transit before product is placed into inventory.
Confirming regulatory posture before ordering
Nebraska's medical board and a practice's own healthcare counsel are the right parties to confirm how a specific intended use is classified under federal HCT/P rules. Precision Biologics does not advise on clinical use, dosing, or procedure design.
Where a physician wants to talk through documentation rather than clinical application, Precision Biologics offers peer-to-peer calls focused on what the paperwork says and how to read it.
FDA has stated there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, not as 361 HCT/Ps. Purchase and clinical use decisions belong to the physician with their own regulatory counsel.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Do you sell to ambulatory surgery centers as well as physician offices in Lincoln?+
Yes. Any licensed physician-directed practice or surgery center with a valid NPI number can apply for a verified account; the product category is the same regardless of setting.
What should an orthopedic group ask for before adding a product to its vendor list?+
Request the certificate of analysis for the lot in question, the donor eligibility summary, and the lot release record, and confirm independently that supplier materials make no disease-specific claims.
Who determines whether our intended use fits the HCT/P framework?+
That determination is made by the practice and its counsel under 21 CFR 1271.10, not by Precision Biologics.