Orion

Overview

Per the manufacturer's materials, designed as a wound covering and protection.

Manufacturer

Surgenex LLC, 15444 N 76 St c110, Scottsdale, AZ 85260, 877-880-1862

Distributor

Legacy Medical Consultants LLC, 9800 Hillwood Pkwy Suite 320, Fort Worth, TX 76177. (817) 961-1288, customerservice@legacymedicalconsultants.com

Tissue type

Human amniotic membrane allograft derived from placental birth tissue (prescreened mother, planned delivery)

Layers

Dual layer

Processing

Aseptic processing; dehydrated; terminally sterilized by electron beam (ANSI/AAMI/ISO 11137)

Regulatory status

Per the IFU and brochure, the FDA Tissue Reference Group confirmed in writing that Orion meets the criteria for regulation solely under Section 361 of the PHS Act (21 CFR Part 1271)

HCPCS Level II code

Q4276 (as printed in the brochure)

Intended use (IFU)

For repair, reconstruction, replacement and/or supplementation by providing tissue in the form of scaffolding in partial and full-thickness acute and chronic wounds. Restricted to use by or on the order of a licensed health care professional.

Storage

Ambient temperature 15-30 C (59-86 F). Do not freeze.

Shelf life

May be stored up to 5 years (IFU); the brochure lists a 5-year shelf life at ambient temperature storage

Handling (IFU)

Single use, one patient, single occasion only. Do not re-sterilize. Do not use on areas with active or latent infection. Once the seal is compromised the allograft must be transplanted or discarded.

Clinical trials

Not yet published

Specs & sizes

Resources

Source: Orion Amniotic Membrane Allograft marketing sheet (24-O-0001-rev1 09/24) and Orion Package Insert (Form 5.2.80 Rev2), Legacy Medical Consultants / Surgenex.

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