# K072528: Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Dec 28, 2007 after 112 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 K971870 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070737: Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories, Prosurg, Inc. (2007) Summary page 2.

## Indications for use
Adjustable Bone Plates™ - Bioabsorbable, Craniofacial Bone Fixation System & Accessories is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face, maxilla and chin in adult and children. * Fractures of the cranium, mid-face, maxilla and chin. * Infant craniofacial surgery (i.e. Craniosynostosis, Congenital malformations) * Le Forte (1, II, III) Osteotomies. * Pediatric Reconstructive procedures of Cranial facial Skeleton. * Orthognathic or Reconstructive procedures of mid-face, maxilla & chin. * Facial Craniotomy flap fixation.

Source page: https://510kreport.com/device/K072528
Methodology: https://510kreport.com/methodology