510(k) · Cleared
ClearedIntelifuse, Inc. Warm System 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 Jun 29, 2005 as substantially equivalent to K993714 (Biomedical Ent., Inc., 2000) after a 29-day review. Its family tree reaches back 2 generations to 1990. 6 later devices descend from it.
- Decided
- Jun 29, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902307 (1990). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 1 generation backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- This deviceK051408 Intelifuse, Inc. Warm System with StimulinksIntelifuse, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK133523 Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK162321 EasyClip XpressRestore Surgical, LLC Dba Instratek · 2017
- Descendant · 3 generations on · 1 of its ownK210582 EasyClip® and EasyClip® XpressStryker GmbH · 2022
- Descendant · cites it directly · 1 of its ownK071477 Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC · 2007
- Descendant · 4 generations on · 0 of its ownK241932 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133523Stapix Superelastic Implant Bone StaplesInstratek, Inc. · 2014 · cites it directly3descendants
- K162321EasyClip XpressRestore Surgical, LLC Dba Instratek · 2017 · 2 generations on2descendants
- K210582EasyClip® and EasyClip® XpressStryker GmbH · 2022 · 3 generations on1descendant
- K071477Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC · 2007 · cites it directly1descendant
- K241932OSSIOfiber® Compression StapleOSSIO, Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −1 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| 0 (this device) | K051408 | Intelifuse, Inc. Warm System with Stimulinks | Intelifuse, Inc. | 2005 | — |
| +1 | K133523 | Stapix Superelastic Implant Bone Staples | Instratek, Inc. | 2014 | — |
| +2 | K162321 | EasyClip Xpress | Restore Surgical, LLC Dba Instratek | 2017 | — |
| +3 | K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | 2022 | — |
| +1 | K071477 | Reverto 55 and 37 Shape Memory Staples | Core Essence Orthopaedics, LLC | 2007 | — |
| +4 | K241932 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K993714 | Memograph Staple, Warm SystemSummary page 1…86 Phone: (714) 695-9269 Fax: (714) 779-0406 Predicate Device(s): Memograph Staple, Warm System, K993714, approved February 25, 2000 (for hand and foot bone fragment, osteo… | 2000 |
What descends from it? (6)
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K133523 (Instratek, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 17 other devices also cite its predicate K993714.
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. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051408: Intelifuse, Inc. Warm System with Stimulinks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051408
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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