# K222220: SpinMedix Absorbable Fibrous Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Celestray Biotech Company, LLC.,
- Decided: Jul 6, 2023 after 346 days
- Product code: OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921895 (1992). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063648: Surgi-Wrap Mast Tendon Sheet, Mast Biosurgery USA, Inc. (2007) Summary page 4.
- K201572: TAPESTRY Biointegrative Implant, Embody, Inc. (2020) Summary page 4.

## Indications for use
The SpinMedix Fibrous Membrane is indicated for management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Source page: https://510kreport.com/device/K222220
Methodology: https://510kreport.com/methodology