# K983756: Surgiform Anatomical Malar

- Pathway: 510(k) (Special)
- Applicant: Surgical Technology Laboratories, Inc.
- Decided: Nov 20, 1998 after 29 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.
2 later devices descend from it; 1 cites 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
Surgiform Anatomical Malar implants can be used by surgeons in 8 unique surgical procedure designed to restore or enhance a patients facial appearance. The implants can be used for aesthetic or reconstructive procedures. The implants can be inserted into a "pocket" created by means of a standard intraoral surgical incision. The implants can elevate and reposition sagging skin and can also fill the hollows and depressions caused by gravity and time. The implants can also be used by surgeons to restore a patients natural appearance as a result of severe facial traums.

Source page: https://510kreport.com/device/K983756
Methodology: https://510kreport.com/methodology