510(k) · Cleared
ClearedIntelifuse, Inc., Warmsystem with Stimulinks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelifuse, Inc. · JDR Staple, Fixation, Bone
Cleared on Apr 3, 2006 after a 90-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 3, 2006
- Review
- 90 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK060014 Intelifuse, Inc., Warmsystem with StimulinksIntelifuse, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK071477 Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC · 2007
- Descendant · 2 generations on · 0 of its ownK141550 Instafix Shape Memory Fixation SystemOt Medical · 2014
- Descendant · cites it directly · 0 of its ownK070688 Nexfix Compression StapleNexa Orthopedics, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060014 | Intelifuse, Inc., Warmsystem with Stimulinks | Intelifuse, Inc. | 2006 | — |
| +1 | K071477 | Reverto 55 and 37 Shape Memory Staples | Core Essence Orthopaedics, LLC | 2007 | — |
| +2 | K141550 | Instafix Shape Memory Fixation System | Ot Medical | 2014 | — |
| +1 | K070688 | Nexfix Compression Staple | Nexa Orthopedics, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDR device
- #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Memograph Staple System with OSStaples Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071477 (Core Essence Orthopaedics, LLC, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDR
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDR
11in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDR
314in 2025
MAUDE reports naming product code JDR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 70 | 0 | 3 |
| 2008 | 5 | 89 | 1 | 14 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 35 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 34 |
| 2013 | 9 | 137 | 0 | 27 |
| 2014 | 11 | 97 | 0 | 49 |
| 2015 | 7 | 111 | 1 | 48 |
| 2016 | 6 | 101 | 0 | 76 |
| 2017 | 9 | 172 | 0 | 116 |
| 2018 | 8 | 107 | 1 | 239 |
| 2019 | 5 | 149 | 0 | 242 |
| 2020 | 4 | 161 | 1 | 234 |
| 2021 | 3 | 62 | 0 | 210 |
| 2022 | 5 | 107 | 11 | 202 |
| 2023 | 9 | 72 | 0 | 175 |
| 2024 | 4 | 29 | 0 | 206 |
| 2025 | 3 | 65 | 0 | 314 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (131 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060014 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060014: Intelifuse, Inc., Warmsystem with Stimulinks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060014
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026