# K111069: Osteosymbionics, ST Temporalis Implant

- Pathway: 510(k) (Traditional)
- Applicant: Osteosymbionics, LLC
- Decided: Sep 22, 2011 after 157 days
- Product code: MNF (Implant, Temporal)
- 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
Longest line of descent: 1 generation back to K943644 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943644: Implantech Temporal Implant, Implantech Associates, Inc. (1994) Summary page 1.
- K002586: Medpor Pterional Surgical Implant, Porex Surgical Products Group (2000). Our reading of the summary gave K002568, FDA’s number for Polymer Coat, Powder Free, Latex Examination Gloves with… (Smart Glove Corp. Sdn Bhd). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Medpor Pterional Surgical Implant”.

## Indications for use
The OsteoSymbionics ST Temporalis Implant is indicated to correct temporal hollowing in patients who have had surgery involving the pterional / lateral approach to the cranium, including pterional / lateral craniotomy or decompressive craniectomy. The OsteoSymbionics ST Temporalis Implant augments the space normally occupied by the temporalis muscle. The implant is used for the reconstruction of temporal contour deformities; the reconstruction of temporal defects, and / or the augmentation / reconstruction of the space normally occupied by the temporalis muscle / temporal area (s).

Source page: https://510kreport.com/device/K111069
Methodology: https://510kreport.com/methodology