# K171037: PoreStar Patient Specific Implant

- Pathway: 510(k) (Traditional)
- Applicant: Anatomics Pty, Ltd.
- Decided: Dec 27, 2017 after 265 days
- Product code: JOF (Polymer, Ent Synthetic, Porous Polyethylene)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922489 (1992). 2 ancestors in all.
1 later device descends 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)
- K083621: Medpor Customized Surgical Implant, Porex Surgical, Inc. (2009) Summary page 4.

## Most influential descendants
- K200532: StarPore (2020), 0 descendants of its own

## Indications for use
The PoreStar Patient Specific Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.

Source page: https://510kreport.com/device/K171037
Methodology: https://510kreport.com/methodology