510(k) · Cleared
ClearedStealth Staple System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
First Ray, LLC · JDR Staple, Fixation, Bone
Cleared on Feb 1, 2017 as substantially equivalent to K153622 (First Ray, LLC, 2016) and 2 other predicates after a 55-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Feb 1, 2017
- Review
- 55 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K915818 (1992). 50 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 6 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 5 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 4 generations backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- 3 generations backK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- 2 generations backK112794 Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · Recalled
- 1 generation backK153395 OS2-C Compression StapleIn2bones Sas · 2016
- This deviceK163440 Stealth Staple SystemFirst Ray, LLC · 2017
- Descendant · cites it directly · 1 of its ownK220181 StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK232324 StealthFix Intraosseous Fixation SystemMedartis, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK190722 TriMAX Implant SystemCrossroads Extemity Systems, LLC · 2019
Most influential descendants
Showing 3 of 3 · See all- K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022 · cites it directly1descendant
- K232324StealthFix Intraosseous Fixation SystemMedartis, Inc. · 2023 · 2 generations on0descendants
- K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −6 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −5 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −4 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| −3 | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| −2 | K112794 | Eos Small Bone Fixation System | TriMed, Inc. | 2012 | 4 |
| −1 | K153395 | OS2-C Compression Staple | In2bones Sas | 2016 | — |
| 0 (this device) | K163440 | Stealth Staple System | First Ray, LLC | 2017 | — |
| +1 | K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | 2022 | — |
| +2 | K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | 2023 | — |
| +1 | K190722 | TriMAX Implant System | Crossroads Extemity Systems, LLC | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K153622 | First Ray Internal Bone Staple SystemSummary page 5…s bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together. Predicate Devices: The Internal Bone Staple System (K153622), marketed as the Stealth Staple System, is the predicate device. The Richards Staple (pre-amendment device), In2Bones, Inc. OS2®… | 2016 |
| * | K153395 | OS2-C Compression StapleSummary page 5…e System (K153622), marketed as the Stealth Staple System, is the predicate device. The Richards Staple (pre-amendment device), In2Bones, Inc. OS2®-C Compression Staple (K153395) and the Solana Surgical LLC Fuse Force Nitinol Staple (K124045) serve as additional predicates. Technological Characteristics C… | 2016 |
| * | K124045 | Fuseforce Implant SystemSummary page 5…e predicate device. The Richards Staple (pre-amendment device), In2Bones, Inc. OS2®-C Compression Staple (K153395) and the Solana Surgical LLC Fuse Force Nitinol Staple (K124045) serve as additional predicates. Technological Characteristics Comparison: The Stealth Staple System has the same design and fun… | 2013 |
| * | — | Richards Staple 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?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 14 of the 50 ancestors have a recall of any class.
- Of its descendants, K220181 (Nextremity Solutions, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K153622.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Stealth Staple 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 as stated in the FDA summary.
https://510kreport.com/device/K163440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163440: Stealth Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163440
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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