510(k) · Cleared
Recalled · Class II · 2026NeoSpan Compression Staple Impant w/instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones USA, LLC · JDR Staple, Fixation, Bone
Cleared on Oct 24, 2016 as substantially equivalent to K112837 (Vilex, Inc., 2012) and 1 other predicate after a 154-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 24, 2016
- Review
- 154 days
- Class
- Class II
- Product code
- JDR
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902307 (1990). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 3 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 2 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- 1 generation backK112837 Vilex EZ-Staple (Memory Bone Fixation Staple)Vilex, Inc. · 2012
- This deviceK161426 NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC · 2016
- Descendant · cites it directly · 0 of its ownK233089 NeoSpan® Compression Implant SystemIn2bones USA, LLC · 2024
- Descendant · cites it directly · 0 of its ownK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −3 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −2 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| −1 | K112837 | Vilex EZ-Staple (Memory Bone Fixation Staple) | Vilex, Inc. | 2012 | — |
| 0 (this device) | K161426 | NeoSpan Compression Staple Impant w/instruments | In2bones USA, LLC | 2016 | — |
| +1 | K233089 | NeoSpan® Compression Implant System | In2bones USA, LLC | 2024 | — |
| +1 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System… | In2bones USA, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K112837 | Vilex EZ-Staple (Memory Bone Fixation Staple)Summary page 4….3030, Class II Product Code: 87 JDR III. Predicate Device Predicate Device: Vilex eZ-Staple Superelastic Bone Fixation Staple K112837 Stryker EasyClip K122113 IV. Device Description The In2Bones NeoSpan™ Compression St… | 2012 |
| * | K122113 | Memory Metal Staples, EasyclipSummary page 4…III. Predicate Device Predicate Device: Vilex eZ-Staple Superelastic Bone Fixation Staple K112837 Stryker EasyClip K122113 IV. Device Description The In2Bones NeoSpan™ Compression Staple Implant w/instruments is a super elastic compression st… | 2013 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2026 | Class II | Z-2355-2026 | Process control | Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. |
| Nov 14, 2018 | Class II | Z-0670-2019 | Employee error | The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K233089 (In2bones USA, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K112837.
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 In2Bones USA NeoSpan™ Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
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/K161426 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161426: NeoSpan Compression Staple Impant w/instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161426
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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