510(k) · Cleared
ClearedMemodyn Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telos Medical Equipment · JDR Staple, Fixation, Bone
Cleared on Jun 13, 2001 after a 288-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jun 13, 2001
- Review
- 288 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK002695 Memodyn StapleTelos Medical Equipment · 2001
- Descendant · cites it directly · 3 of its ownK170923 JAWS (TM) Nitinol Staple SystemParagon 28 · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK223056 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK161587 Memodyn StapleAustin & Associates, Inc./Telos Medical Equipment · 2017
- Descendant · 3 generations on · 1 of its ownK230550 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK071477 Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC · 2007
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K170923JAWS (TM) Nitinol Staple SystemParagon 28 · 2017 · cites it directly3descendants
- K223056JAWS Nitinol Staple SystemParagon 28, Inc. · 2023 · 2 generations on2descendants
- K161587Memodyn StapleAustin & Associates, Inc./Telos Medical Equipment · 2017 · cites it directly2descendants
- K230550JAWS Nitinol Staple SystemParagon 28, Inc. · 2023 · 3 generations on1descendant
- K071477Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC · 2007 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002695 | Memodyn Staple | Telos Medical Equipment | 2001 | — |
| +1 | K170923 | JAWS (TM) Nitinol Staple System | Paragon 28 | 2017 | 1 |
| +2 | K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023 | — |
| +1 | K161587 | Memodyn Staple | Austin & Associates, Inc./Telos Medical Equipment | 2017 | — |
| +3 | K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023 | — |
| +1 | K071477 | Reverto 55 and 37 Shape Memory Staples | Core Essence Orthopaedics, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2023 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
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?
- Of its descendants, K170923 (Paragon 28, 2017) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JDR devicesJDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K002695 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002695: Memodyn Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002695
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026