510(k) · Cleared
ClearedStealthFix Intraosseous Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medartis, Inc. · JDR Staple, Fixation, Bone
Cleared on Aug 30, 2023 as substantially equivalent to K220181 (Nextremity Solutions, Inc., 2022) after a 27-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Aug 30, 2023
- Review
- 27 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K915818 (1992). 52 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 5 generations between
- 3 generations backK153395 OS2-C Compression StapleIn2bones Sas · 2016
- 2 generations backK163440 Stealth Staple SystemFirst Ray, LLC · 2017
- 1 generation backK220181 StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022
- This deviceK232324 StealthFix Intraosseous Fixation SystemMedartis, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 8 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 7 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 6 generations backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- 5 generations backK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- 4 generations backK112794 Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · Recalled
- 3 generations backK153395 OS2-C Compression StapleIn2bones Sas · 2016
- 2 generations backK163440 Stealth Staple SystemFirst Ray, LLC · 2017
- 1 generation backK220181 StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022
- This deviceK232324 StealthFix Intraosseous Fixation SystemMedartis, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −8 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −7 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −6 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| −5 | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| −4 | K112794 | Eos Small Bone Fixation System | TriMed, Inc. | 2012 | 4 |
| −3 | K153395 | OS2-C Compression Staple | In2bones Sas | 2016 | — |
| −2 | K163440 | Stealth Staple System | First Ray, LLC | 2017 | — |
| −1 | K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | 2022 | — |
| 0 (this device) | K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K220181 | StealthFix Intraosseous Fixation SystemSummary page 4…ber 888.3030 Product Code JDR I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K220181 StealthFix Intraosseous Fixation System JDR Device Description Summary 21 CFR 807.92(a)(4) The StealthFix Intraosseous Fixation… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 14 of the 52 ancestors have a recall of any class.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for
bone reconstructions, including:
* Arthrodesis in hand or foot surgery
* Mono or bi-cortical osteotomies in the foot or hand
* Fracture management in the foot or hand
* Distal or proximal metatarsal or metacarpal osteotomies
» Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232324: StealthFix Intraosseous Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232324
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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