# K161052: OsteoFab Patient Specific Facial Device

- Pathway: 510(k) (Special)
- Applicant: Oxford Performance Materials, Inc.
- Decided: Jul 20, 2016 after 97 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: 7 generations back to K791495 (1979). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133809: Osteofab Patient Specific Facial Device, Oxford Performance Materials (2014) Summary page 4.

## 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/K161052
Methodology: https://510kreport.com/methodology