510(k) · Cleared
ClearedFirst Ray Internal Bone 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 Apr 8, 2016 as substantially equivalent to K011716 (New Deal, S.A., 2001) and 1 other predicate after a 112-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Apr 8, 2016
- Review
- 112 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K964226 (1997). 8 ancestors in all, the oldest K895117 (1990). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
- 2 generations backK991482 Uni-Clip StapleNew Deal, S.A. · 1999
- 1 generation backK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
- This deviceK153622 First Ray Internal Bone Staple SystemFirst Ray, LLC · 2016
- Descendant · cites it directly · 3 of its ownK163440 Stealth Staple SystemFirst Ray, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK220181 StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022
- Descendant · 3 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 4 of 4 · See all- K163440Stealth Staple SystemFirst Ray, LLC · 2017 · cites it directly3descendants
- K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022 · 2 generations on1descendant
- K232324StealthFix Intraosseous Fixation SystemMedartis, Inc. · 2023 · 3 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 |
|---|---|---|---|---|---|
| −3 | K964226 | Memory Staple (20 Sizes Available) | Landos, Inc. | 1997 | — |
| −2 | K991482 | Uni-Clip Staple | New Deal, S.A. | 1999 | — |
| −1 | K011716 | The Uni-Clip Staple | New Deal, S.A. | 2001 | 1 |
| 0 (this device) | K153622 | First Ray Internal Bone Staple System | First Ray, LLC | 2016 | — |
| +1 | K163440 | Stealth Staple System | First Ray, LLC | 2017 | — |
| +2 | K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | 2022 | — |
| +3 | 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 |
|---|---|---|
| 1990 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K011716 | The Uni-Clip StapleSummary page 5…K153622 Internal Bone Staple – Traditional 510(k) Predicate Device: The Richards Staple (pre-amendment), NewDeal Uni-Clip Staple (K011716) and Synthes Cannulated Screw (K963192) serve as the predicate devices. Technological Characteristics Comparison: The Internal B… | 2001 |
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 5…Internal Bone Staple – Traditional 510(k) Predicate Device: The Richards Staple (pre-amendment), NewDeal Uni-Clip Staple (K011716) and Synthes Cannulated Screw (K963192) serve as the predicate devices. Technological Characteristics Comparison: The Internal Bone Staple System and its predicates ar… | 1996 |
| * | — | Richards Staple (pre-amendment) Named without a submission number |
What descends from it? (4)
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 19 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K163440 (First Ray, LLC, 2017) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K011716.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 First Ray Internal Bone 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/K153622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153622: First Ray Internal Bone Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153622
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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