# K091011: Pureform Eptfe Facial Implants (Nasal, Chin, Maler)

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Technology Laboratories, Inc ("Stl")
- Decided: Apr 22, 2009 after 13 days
- Product code: FWP (Prosthesis, Chin, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933367 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933367: Gore-Tex Facial Implant, W. L. Gore & Associates, Inc. (1994) Summary page 1.
- K021889: Surgiform Augmentation Material (S.F.a.M.), Surgical Technology Laboratories, Inc. (2002) Summary page 1.
- K983754: Standard Chin, Surgical Technology Laboratories, Inc. (1998) Summary page 1.
- K983755: Nasal Dorsal Series, Surgical Technology Laboratories, Inc. (1998) Summary page 1.
- K983756: Surgiform Anatomical Malar, Surgical Technology Laboratories, Inc. (1998) Summary page 1.
- K002886: Implantech Composite Facial Implants (Malar, Chin, and Nasal), Implantech Associates, Inc. (2000) Summary page 1.

## Most influential descendants
- K201153: Tisuthes e-PTFE Surgical Patch (2023), 0 descendants of its own

## Indications for use
PureForm ePTFE Facial Implants are indicated for use in facial plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K091011
Methodology: https://510kreport.com/methodology