# K022035: Osteomedics Resorbable Small Fixation System, Osteosorb

- Pathway: 510(k) (Traditional)
- Applicant: Osteomedics, Inc.
- Decided: Jan 17, 2003 after 210 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bionx BiosorbFx 1Y2.0 Bioabsorbable Fixation System: named in the summary without a submission number
- (no number) BiosorbFx 2.0/2.4 Orthognathic / Mandibular Fix: named in the summary without a submission number
- (no number) Stryker Leibinger Wurzburg Titanium Mini Bone Plates and Bone Screws: named in the summary without a submission number

## Most influential descendants
- K030989: Osteosorb Tack Fixation System (2004), 0 descendants of its own

## Indications for use
The OsteomedicsB Resorbable Small Fixation System is intended for use in selective trauma or for reconstructive procedures in the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures, and selective orthognathic surgery of the maxilla and chin. The OsteomedicsB Resorbable Small Fixation System stabilizes bone during healing in conjunction with appropriate postoperative immobilization. The use is in both adult and pediatric patients' cases involving trauma or reconstruction.

Source page: https://510kreport.com/device/K022035
Methodology: https://510kreport.com/methodology