# K952677: Medpor Barrier Surgical Implant Biomaterial

- Pathway: 510(k) (Traditional)
- Applicant: Porex Surgical, Inc.
- Decided: Aug 21, 1995 after 70 days
- Product code: FWP (Prosthesis, Chin, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K183472: DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional (2019), 0 descendants of its own

## Recalls of this device
- Dec 17, 2014 · Class II · Z-1092-2015: Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
- Dec 17, 2014 · Class II · Z-1091-2015: Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

Source page: https://510kreport.com/device/K952677
Methodology: https://510kreport.com/methodology