# K200532: StarPore

- Pathway: 510(k) (Traditional)
- Applicant: Anatomics Pty, Ltd.
- Decided: Jun 2, 2020 after 92 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: 3 generations back to K922489 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171037: PoreStar Patient Specific Implant, Anatomics Pty, Ltd. (2017) Summary page 4.

## Indications for use
StarPore™ implants are intended for the restoration or augmentation of bony contour in craniofacial defects.

Source page: https://510kreport.com/device/K200532
Methodology: https://510kreport.com/methodology