# K012486: Osteomed Bioresorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Corp.
- Decided: Jan 16, 2002 after 167 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K904436 (1990). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972913: Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces (1998) Summary page 1.
- K974554: Synthes Resorbable Fixation System, Synthes (Usa) (1998) Summary page 1.
- K993061: Stryker Leibinger Resorbable Fixation System, Stryker Instruments (1999) Summary page 1.

## Indications for use
Indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall and midfacial fractures, and reconstructive procedures of the midface or craniofacial skeleton. The OsteoMed Bioresorbable Fixation System is not intended for use in and is contraindicated for: the mandible and/or full load bearing procedures; in cases of active or suspected infection or in patients who are immunocompromised; in cases where there is limitation of the blood supply or inadequate volume or quality of bone to place the system securely, in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation.

Source page: https://510kreport.com/device/K012486
Methodology: https://510kreport.com/methodology