# K102324: Endofuse Intra-Osseous Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 4, 2011 after 260 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K053309: Altaire Interventional MR Package, Hitachi Medical Systems America, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The ENDO-FUSE® Intra-Osseous Fusion System Rods are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies.) The ENDO-FUSE® Intra-Osseous Fusion System Beams are indicated for lateral column lengthening and for fusions of any joint in the foot/ankle appropriate for the size of the device, including tarso-metatarsal, metatarsal-cuneiform, calcaneal-cuboid, talo-navicular, LisFranc, Four-Corner, subtalar, and ankle joint.

Source page: https://510kreport.com/device/K102324
Methodology: https://510kreport.com/methodology