# K024199: Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP

- Pathway: 510(k) (Traditional)
- Applicant: Osteobiologics, Inc.
- Decided: Mar 14, 2003 after 84 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 1 generation back to K012025 (2001). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012025: Macropore Surgiwrap (TS), Macropore Biosurgery, Inc. (2001)

## Most influential descendants
- K082079: Regen Collagen Scaffold (CS) (2008), 2 descendants of its own
- K170364: Collagen Meniscus Implant XL (2017), 1 descendant of its own
- K242302: RejuvaKnee™ Collagen Meniscus Implant (2024), 0 descendants of its own

## Indications for use
The IMMIXTMThin Film is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

Source page: https://510kreport.com/device/K024199
Methodology: https://510kreport.com/methodology