# K070737: Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Jul 25, 2007 after 131 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: 2 generations back to K971870 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050608: Synthes Carniofacial Plate and Screw System, Synthes (Usa) (2005) Summary page 1.
- K051341: Inion CPS Baby 1.5 Bioabsorbable Fixation System, 40 and 64 Hole Plates, Models PLT-1058 and PLT-1059, Inion, Ltd. (2005) Summary page 1.
- K040650: Bonamates Series, Biotech One, Inc. (2004) Summary page 1.

## Most influential descendants
- K072528: Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & Accessories (2007), 0 descendants of its own

## Indications for use
General Indication for Use: XsorbTM - 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. Specific Indications for Use: * 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/K070737
Methodology: https://510kreport.com/methodology