# K944165: Silhouette Malar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Designs, Inc.
- Decided: Nov 4, 1994 after 70 days
- Product code: LZK (Implant, Malar)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jun 15, 2007 · Not classified · Z-1206-2007: The product is being recalled because it was discovered the at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, i

Source page: https://510kreport.com/device/K944165
Methodology: https://510kreport.com/methodology