# K050492: Integra Bone Fixation System

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corp.
- Decided: Mar 14, 2005 after 14 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040860 (2004). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040860: Integra Bone Fixation System, Integra LifeSciences Corporation (2004) Summary page 1.

## Most influential descendants
- K073342: Salvin Dental Specialties, Inc., Fixation Screw (2008), 5 descendants of its own
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own
- K170697: GBR system (2018), 2 descendants of its own
- K222367: Save GBR (2023), 0 descendants of its own
- K182759: BoniPlus Dental G-Mesh System (2020), 0 descendants of its own

## Indications for use
The Integra Bone Fixation System is intended for use in internal fixation of small bones affected by trauma, for reconstruction, or arthrodesis. Burr Hole cover plates are intended specifically to cover burr holes and to secure cranial flaps.

Source page: https://510kreport.com/device/K050492
Methodology: https://510kreport.com/methodology