# K961210: Sam Facial Implant

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jun 19, 1996 after 83 days
- Product code: LZK (Implant, Malar)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SAM Facial Implant: named in the summary without a submission number
- (no number) Non-Reinforced SAM Facial Implant: named in the summary without a submission number
- (no number) R L SAM Facial Implant with Introducer: named in the summary without a submission number

## Indications for use
SAM Facial Implant materials are indicated for plastic and reconstructive surgery. No new intended uses or new indications will be implemented as a result of this submission’s clearance.

Source page: https://510kreport.com/device/K961210
Methodology: https://510kreport.com/methodology