# K012413: Macropore FX, PS, NS, LP

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Sep 18, 2001 after 50 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002207: Macroporepx Pediatric System, Macropore Biosurgery, Inc. (2001) Summary page 3.
- K972913: Macropore Protective Sheet (Protego System), Pacific Materials and Interfaces (1998) Summary page 3.

## Indications for use
A. General Indications: Trauma procedures of the midface or craniofacial skeleton. Specific Indications: 1). Comminuted fractures of the naso-ethmoidal infraorbital areas. 2). Comminuted fractures of the frontal sinus wall. 3). Pediatric midface or craniofacial trauma 4). Lefort (I, II, IIT) fractures. 5). Orbital floor fractures. 6).Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7). Trauma of the craniofacial skeleton including: frontal, parietal, temporal , sphenoid, and occipital bones. B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton.. Specific Indications: 1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.). 2). Lefort (1, II, II) osteotomies. 3). Tumor reconstruction in midface or craniofacial procedures. 4). Bone graft procedures in the midface or craniofacial skeleton. 5). Pediatric reconstructive procedures. 6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones. 7). Craniotomy flap fixation.

Source page: https://510kreport.com/device/K012413
Methodology: https://510kreport.com/methodology