# K973502: Implantech Conform Binder Submalar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Implantech Associates, Inc.
- Decided: Nov 7, 1997 after 52 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Implantech Conform™ Combined Submalar® Implant is indicated for implantation to "augment or reconstruct the underdeveloped or traumatized malar region of the face. The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.

Source page: https://510kreport.com/device/K973502
Methodology: https://510kreport.com/methodology