# K992905: Codman Craniosorb Absorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Aug 1, 2000 after 337 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 K900138 (1990). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 1.
- K972913: Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces (1998) Summary page 1.

## Most influential descendants
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- K121606: Resorb-X G (2013), 0 descendants of its own
- K101835: Medpor Fixation System-Cranial, Models 80080, 80079 (2010), 0 descendants of its own

## Indications for use
The CODMAN® CRANIOSORB™ Absorbable Fixation System is intended for surgical procedures in which internal fixation is required to align and stabilize bony tissue for craniofacial skeletal reconstruction and the repair of traumatic fractures of the craniofacial skeleton. The CODMAN® CRANIOSORB™ Absorbable Fixation System is contraindicated for use in the mandible and as a primary source of fixation in weight bearing areas.

Source page: https://510kreport.com/device/K992905
Methodology: https://510kreport.com/methodology