# K051408: Intelifuse, Inc. Warm System with Stimulinks

- Pathway: 510(k) (Traditional)
- Applicant: Intelifuse, Inc.
- Decided: Jun 29, 2005 after 29 days
- Product code: JDR (Staple, 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: 2 generations back to K902307 (1990). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 1.

## Most influential descendants
- K133523: Stapix Superelastic Implant Bone Staples (2014), 3 descendants of its own
- K162321: EasyClip Xpress (2017), 2 descendants of its own
- K210582: EasyClip® and EasyClip® Xpress (2022), 1 descendant of its own
- K071477: Reverto 55 and 37 Shape Memory Staples (2007), 1 descendant of its own
- K241932: OSSIOfiber® Compression Staple (2024), 0 descendants of its own

## Indications for use
The InteliFUSE, Inc. Warm System with StimuLinks are used as a system for the following indications: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis 2) fixation of proximal tibial metaphysis osteotomy 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.

Source page: https://510kreport.com/device/K051408
Methodology: https://510kreport.com/methodology