# K060014: Intelifuse, Inc., Warmsystem with Stimulinks

- Pathway: 510(k) (Traditional)
- Applicant: Intelifuse, Inc.
- Decided: Apr 3, 2006 after 90 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
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Memograph Staple System with OSStaples: named in the summary without a submission number

## Most influential descendants
- K071477: Reverto 55 and 37 Shape Memory Staples (2007), 1 descendant of its own
- K141550: Instafix Shape Memory Fixation System (2014), 0 descendants of its own
- K070688: Nexfix Compression Staple (2007), 0 descendants of its own

## Indications for use
The InteliFUSE, Inc. Warmsystem with StimuLinks is 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. 4) fixation of maxillofacial and mandibulofacial fractures and osteotomies. 5) fixation of unloaded craniofacial bone fractures and craniostomies. The StimuLinks are contraindicated for craniofacial patients with a skull thickness less than the selected prong length. 6) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

Source page: https://510kreport.com/device/K060014
Methodology: https://510kreport.com/methodology