# K111176: Osteomed Low Profile Neuro Fixation System

- Pathway: 510(k) (Special)
- Applicant: Osteomed LP
- Decided: Aug 15, 2011 after 110 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911936 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911936: Osteomed SBF System (SBF), Osteomed Corp. (1991) Summary page 1.
- K924138: Osteomed M3 System (SBF System), Osteomed Corp. (1993) Summary page 1.

## Most influential descendants
- K141123: Alliance Spine Raas Cranial Plating System (2015), 0 descendants of its own

## Recalls of this device
- May 31, 2023 · Class II · Z-2107-2023: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
- May 31, 2023 · Class II · Z-2108-2023: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

## Indications for use
The OSTEOMED Low Profile Neuro Fixation System is indicated for use in osteotomies, fractures or reconstructions of the cranial bones. Implants and drills are single use only.

Source page: https://510kreport.com/device/K111176
Methodology: https://510kreport.com/methodology