# K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Bionx Implants, Inc.
- Decided: Sep 15, 1998 after 90 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: 3 generations back to K904436 (1990). 19 ancestors in all.
86 later devices descend from it; 5 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974554: Synthes Resorbable Fixation System, Synthes (Usa) (1998) Summary page 1.
- K974309: Lactosorb Panels, Biomet, Inc. (1998) Summary page 1.
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 1.
- K960988: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 1.
- K972919: Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift Screw, Bionx Implants, Inc. (1998) Summary page 1.
- K972783: Biofix Biodegradable Threaded Suture Anchor, Bionx Implants, Inc. (1998) Summary page 1.

## Most influential descendants
- K993061: Stryker Leibinger Resorbable Fixation System (1999), 79 descendants of its own
- K011590: Resorb-X Resorbable Plating System (2002), 73 descendants of its own
- K060177: KLS Martin Rigid Fixation  - Sterile (2006), 65 descendants of its own
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile (2007), 61 descendants of its own
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own

## Indications for use
The BioSorbFX System is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating comminuted fractures of the naseothmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; trauma of the midface and craniofacial skeleton, and reconstructive procedures of the midface or craniofacial skeleton. The BioSorbFX System is used to stabilize bone during healing in conjunction with appropriate postoperative immobilization. The BioSorbFX System includes an instrumentation set containing bone drills, bone taps, screwdrivers and plate benders. The BioSorbFX System is not intended for use in: 1) the mandible; 2) full load bearing procedures; 3) areas with active infection; or 4) patient conditions, including blood supply limitations, insufficient quantity or quality of bone, or latent infections.

Source page: https://510kreport.com/device/K982139
Methodology: https://510kreport.com/methodology