# K982721: Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Bionx Implants, Inc.
- Decided: Feb 17, 1999 after 197 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: 4 generations back to K904436 (1990). 20 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 27 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.
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System, Bionx Implants, Inc. (1998). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K011569: Biosorbfx O/M 2.0/2/4 System (2002), 5 descendants of its own
- K061881: Osteotrans -MX Bioabsorbable Bone Fixation System (2007), 3 descendants of its own
- 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 BioSorbFX 2.0/2.4 Bioabsorbable Fixation System (“BioSorbFX 2.0/2.4 System”) is intended for use in trauma and reconstructive procedures in the midface and maxilla. Specifically, the device is indicated for use in surgical repair procedures in the treatment of trauma to the midface and maxilla, and in orthognathic and reconstructive procedures of the midface or maxilla. An instrumentation set which is used to implant the fasteners to secure the plates to bone is included with the BioSorbFX 2.0/2.4 System. The BioSorbFX 2.0/2.4 System is not intended for use in mandibular applications.

Source page: https://510kreport.com/device/K982721
Methodology: https://510kreport.com/methodology