510(k) · Cleared
ClearedVilex EZ-Staple (Memory Bone Fixation Staple)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vilex, Inc. · JDR Staple, Fixation, Bone
Cleared on Oct 9, 2012 as substantially equivalent to K070031 (Memometal Technologies, 2007) after a 377-day review. Its family tree reaches back 3 generations to 1990. 5 later devices descend from it.
- Decided
- Oct 9, 2012
- Review
- 377 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902307 (1990). 4 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 2 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 1 generation backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- This deviceK112837 Vilex EZ-Staple (Memory Bone Fixation Staple)Vilex, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK161426 NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK233089 NeoSpan® Compression Implant SystemIn2bones USA, LLC · 2024
- Descendant · cites it directly · 0 of its ownK231493 NITINEX Memory Compression StapleVilex, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK190385 CoLink Plating System, Fracture and Correction System, RTS Implant…In2bones USA, LLC · 2019
- Descendant · cites it directly · 0 of its ownK150211 EzFuze Implant SystemVilex IN Tennessee, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC · 2016 · cites it directly2descendants
- K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC · 2024 · cites it directly0descendants
- K231493NITINEX Memory Compression StapleVilex, LLC · 2023 · cites it directly0descendants
- K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC · 2019 · 2 generations on0descendants
- K150211EzFuze Implant SystemVilex IN Tennessee, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −2 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −1 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| 0 (this device) | K112837 | Vilex EZ-Staple (Memory Bone Fixation Staple) | Vilex, Inc. | 2012 | — |
| +1 | K161426 | NeoSpan Compression Staple Impant w/instruments | In2bones USA, LLC | 2016 | 2 |
| +1 | K233089 | NeoSpan® Compression Implant System | In2bones USA, LLC | 2024 | — |
| +1 | K231493 | NITINEX Memory Compression Staple | Vilex, LLC | 2023 | — |
| +2 | K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System… | In2bones USA, LLC | 2019 | — |
| +1 | K150211 | EzFuze Implant System | Vilex IN Tennessee, Inc. | 2015 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K070031 | Memometal Memory StaplesSummary page 1…ssories Product Code: JDR Regulatory Class: 11 Predicate Devices Memnometal Technologies' Memnometal Memory Staples - K070031 - (Trade name: MMI EasyClip® SI) The Vilex eZ-Staple Superelastic Bone Fixation Sta… | 2007 |
What descends from it? (5)
4 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 22 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K161426 (In2bones USA, LLC, 2016) has gone furthest, with 2 descendants of its own.
- 12 other devices also cite its predicate K070031.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Vilex memory bone fixation staples (eZ-Staple) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112837: Vilex EZ-Staple (Memory Bone Fixation Staple).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112837
Report an extraction error
Are you the manufacturer?
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