# K133809: Osteofab Patient Specific Facial Device

- Pathway: 510(k) (Traditional)
- Applicant: Oxford Performance Materials
- Decided: Jul 28, 2014 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K791495 (1979). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924935: Hard Tissue Replace (HTR (R))-Patient-Match Implant, Polyclinic Medical Center (1993) Summary page 1.
- K111323: Synthes Synpor HD Porous Polyethylene Threr Dimensional Implants, Synthes, Inc. (2011) Summary page 1.
- K103010: Stryker Patient Specific Polymer Implant, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2010) Summary page 1.

## Most influential descendants
- K161052: OsteoFab Patient Specific Facial Device (2016), 0 descendants of its own

## Indications for use
The OsteoFab™ Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

Source page: https://510kreport.com/device/K133809
Methodology: https://510kreport.com/methodology