# K040860: Integra Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: Jun 17, 2004 after 76 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
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TiMesh® System: named in the summary without a submission number
- (no number) Centre-Drive Drill-Free™ Screws: named in the summary without a submission number
- (no number) LEIBINGER® Bone Plates and Bone Screws: named in the summary without a submission number

## Most influential descendants
- K050492: Integra Bone Fixation System (2005), 6 descendants of its own
- K073342: Salvin Dental Specialties, Inc., Fixation Screw (2008), 5 descendants of its own
- K160177: Gridlock Ankle Plating System (2016), 3 descendants of its own
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own
- K191009: Arsenal Plating System (2019), 2 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/K040860
Methodology: https://510kreport.com/methodology