Orthopedic Biologics Supplier Serving San Diego, CA

Shipping Wharton's jelly and exosome products to the West

Cryopreserved products ship overnight on dry ice in validated shipping containers regardless of destination, moving directly into -80 degree C storage once received. Practices on the West Coast, including San Diego, typically assign receiving staff to confirm the shipment arrived within its validated condition and to log the lot number before transfer to final storage, the same intake step used anywhere in the country.

Lyophilized Wharton's jelly and lyophilized exosome products are described by the supplier as shelf-stable and are handled per the product insert included with the lot rather than a cold-chain protocol.

How orthopedic surgery centers vet a new supplier

A surgery center typically runs a new biologics vendor through the same intake process used for implants: confirming the account is tied to a verified NPI, reviewing lot-specific documentation rather than marketing claims, and checking that the supplier can reproduce that documentation consistently across orders.

• NPI verification before any order
• Certificate of analysis per lot
• Donor eligibility summary on request
• Lot release record for traceability at the patient-record level

Regulatory review sits with the practice and its counsel

Whether a specific intended use for a Wharton's jelly product fits within the framework described in 21 CFR 1271.10, covering minimal manipulation and homologous use, is a determination the practice and its counsel make, not the distributor. We recommend confirming your practice's standing directly with the California medical board and your own counsel before adding any product to a purchasing list.

These products are not FDA approved or licensed for any disease or condition; this page is written for licensed healthcare professionals and is not medical or legal advice.

Opening a San Diego account

Account setup starts with NPI verification. Once verified, Precision Biologics makes lot documentation available on request and offers access to physician-level conversations about that documentation, not clinical guidance. Pricing is available to verified accounts rather than published.

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.