510(k) · Cleared
ClearedMemodyn Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Austin & Associates, Inc./Telos Medical Equipment · JDR Staple, Fixation, Bone
Cleared on Feb 1, 2017 as substantially equivalent to K002695 (Telos Medical Equipment, 2001) after a 238-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Feb 1, 2017
- Review
- 238 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002695 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002695 Memodyn StapleTelos Medical Equipment · 2001
- This deviceK161587 Memodyn StapleAustin & Associates, Inc./Telos Medical Equipment · 2017
- Descendant · cites it directly · 0 of its ownK173693 Orbitum Bone Staple Implant, X and VIOrthovestments, LLC · 2018
- Descendant · cites it directly · 0 of its ownK172205 ExoToe StapleExotoe, LLC · 2018
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 |
|---|---|---|---|---|---|
| −1 | K002695 | Memodyn Staple | Telos Medical Equipment | 2001 | — |
| 0 (this device) | K161587 | Memodyn Staple | Austin & Associates, Inc./Telos Medical Equipment | 2017 | — |
| +1 | K173693 | Orbitum Bone Staple Implant, X and VI | Orthovestments, LLC | 2018 | — |
| +1 | K172205 | ExoToe Staple | Exotoe, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K002695 | Memodyn StapleSummary page 4…LASSIFICATION Single/multiple component metallic bone fixation appliances and NAME: accessories PRODUCT CODE JDR PREDICATE DEVICE: Memodyn Staple (K002695) REFERENCE DEVICE Vilex Staple (K112837) INTENDED USE/INDICATIONS FOR USE Memodyn Staple is intended for use in bone fixation o… | 2001 |
| † | K112837 | Vilex EZ-Staple (Memory Bone Fixation Staple) | 2012 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.
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/K161587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161587: Memodyn Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161587
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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