# K042517: Biosorb FX and Biosorb PDX 1.5 and 2.0 Screws

- Pathway: 510(k) (Special)
- Applicant: Linvatec Biomaterials, Ltd.
- Decided: Oct 8, 2004 after 23 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: 6 generations back to K904436 (1990). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System, Bionx Implants, Inc. (1998) Summary page 1.
- K982721: Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System, Bionx Implants, Inc. (1999) Summary page 1.
- K011569: Biosorbfx O/M 2.0/2/4 System, Bionx Implants, Inc. (2002)
- K000836: Biosorbpdx Bioabsorbable Fixation System, Bionx Implants, Inc. (2000) Summary page 1.

## Indications for use
O 1.5 and 2.0mm screw models of BioSorbTM FX and BioSorbTM PDX are used for plate fixation fasteners in trauma and constructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; orbital floor fractures; trauma of the midface or craniofacial skeleton and reconstructive procedures of the midface or craniofacial skeleton. O 2.0 mm screw models of BioSorbTM FX can be used for plate fixation fasteners with BioSorbTM FX 2.0/2.4 O/M plates in trauma and reconstructive procedures in the midface, maxilla and mandible. Especially in mandible BioSorbTM FX 2.0/2.4 O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).

Source page: https://510kreport.com/device/K042517
Methodology: https://510kreport.com/methodology