# K133046: Omnipore Customized Surgical Implants

- Pathway: 510(k) (Traditional)
- Applicant: Matrix Surgical Holdings, LLC/Matrix Surgical USA
- Decided: May 14, 2014 after 229 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922489 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123908: Omnipore Surgical Implants and Accessories, Matrix Surgical USA (2013) Summary page 4.
- K083621: Medpor Customized Surgical Implant, Porex Surgical, Inc. (2009) Summary page 4.

## Recalls of this device
- Jan 25, 2017 · Class II · Z-1382-2017: Mislabeling. The packaging labeled as left mandible contained a right mandible.

## Indications for use
OmniPore® Customized Surgical Implants are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. OmniPore Customized Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

Source page: https://510kreport.com/device/K133046
Methodology: https://510kreport.com/methodology