# K011569: Biosorbfx O/M 2.0/2/4 System

- Pathway: 510(k) (Traditional)
- Applicant: Bionx Implants, Inc.
- Decided: Feb 22, 2002 after 277 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: 5 generations back to K904436 (1990). 30 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 36 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.
- K981666: 2.5 MM Lactosorb Screws, Biomet, Inc. (1998) Summary page 1.
- K992158: Lactosorb Sheets, Biomet, Inc. (1999) Summary page 1.
- K003786: SMF Resorbable Meshes and Sheets, Synthes (Usa) (2001) Summary page 1.
- K002083: Lorenz Resorbable Distractor System, Walter Lorenz Surgical, Inc. (2001) Summary page 1.
- K000696: Macroporemx Mandibular Fixation System, Macropore Biosurgery, Inc. (2000) Summary page 1.
- K983360: Macropore Protective Sheet, Pacific Materials and Interfaces (1999) Summary page 2.

## Most influential descendants
- 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
- K042517: Biosorb FX and Biosorb PDX 1.5 and 2.0 Screws (2004), 0 descendants of its own

## Indications for use
The BioSotbFX O/M 2i0/2.4 System is intended for usc in trauma and recorstructive procedures in the midface, maxilla and mandible. Specifically, the device is indicated for use in surgical repair procedures in the treatment of traurna to the midfac { maxilla and mandible, and in orthognathic and reconstructive procedures of the mnidface, maxilla or wandible. The BioSorbFX O/M 2.0/2.4 System stabilizes borfe during healing, in conjunction with appropriate postoperative immobiliz:tion. Especially in mandible BioSorbFX O/M System must be used in comjunction of ap‘?ropriatc maxillomandibular fixation (MMF). The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in, and are contraindicated for: 1. Mandibular tumor resection. 2. Simations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficicnt quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism). 3. Significant comminuted fractures, including significant bone loss,i of the mandible. 4. Jotermaxillary fixation without an appropriate extemal fixation by other means.

Source page: https://510kreport.com/device/K011569
Methodology: https://510kreport.com/methodology