# K021889: Surgiform Augmentation Material (S.F.a.M.)

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Technology Laboratories, Inc.
- Decided: Oct 16, 2002 after 131 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K091011: Pureform Eptfe Facial Implants (Nasal, Chin, Maler) (2009), 1 descendant of its own
- K201153: Tisuthes e-PTFE Surgical Patch (2023), 0 descendants of its own

## Indications for use
For Plastic and Reconstructive Surgery

Source page: https://510kreport.com/device/K021889
Methodology: https://510kreport.com/methodology