# K961719: Epitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Leibinger, Inc.
- Decided: Jul 17, 1997 after 441 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K990458: Straumann Extraoral Implant System (1999), 2 descendants of its own
- K161548: Osseointegrated Fixtures (2016), 1 descendant of its own
- K241253: Medicon Epiplating System (2024), 0 descendants of its own

## Indications for use
The Epitec system can be used for the fixation of diverse kinds of craniofacial prostheses, including the following examples: Ear prostheses Orbital prostheses Nose prostheses Cheek prostheses Hair Pieces Although the Epitec system will primarily be used for the alloplastic reconstruction of craniofacial defects caused by genetic anomalies, tumor resections, or trauma, it can also be used in other craniofacial cases best treated with surgical anchoring.

Source page: https://510kreport.com/device/K961719
Methodology: https://510kreport.com/methodology