# K123908: Omnipore Surgical Implants and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Matrix Surgical USA
- Decided: Jul 31, 2013 after 224 days
- Product code: KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction)
- Device class: 2
- Regulation: 21 CFR 878.3500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922489 (1992). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922489: Medpor Surg Implant Material:Prefor Cran/Fac Impla, Porex Technologies Corp. (1992) Summary page 1.

## Most influential descendants
- K140437: SU-Por Surgical Implant (2014), 2 descendants of its own
- K211514: Longeviti PorousFit implant (2021), 0 descendants of its own
- K160988: Biopor, AOC Porous Polyethylene, Cerepor (2016), 0 descendants of its own
- K152463: SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (2016), 0 descendants of its own
- K133046: Omnipore Customized Surgical Implants (2014), 0 descendants of its own

## Recalls of this device
- Jan 30, 2019 · Class II · Z-1223-2019: Product mislabeling.
- Jan 30, 2019 · Class II · Z-1224-2019: Product mislabeling.
- Jan 25, 2017 · Class II · Z-1382-2017: Mislabeling. The packaging labeled as left mandible contained a right mandible.

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

Source page: https://510kreport.com/device/K123908
Methodology: https://510kreport.com/methodology