510(k) · Cleared
ClearedMetasurg Nitinol Staple Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metasurg · JDR Staple, Fixation, Bone
Cleared on May 3, 2013 as substantially equivalent to K070031 (Memometal Technologies, 2007) and 1 other predicate after a 134-day review. Its family tree reaches back 3 generations to 1990. 6 later devices descend from it.
- Decided
- May 3, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K902307 (1990). 4 ancestors in all. 6 later devices descend from it, 1 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 deviceK123926 Metasurg Nitinol Staple ImplantMetasurg · 2013
- Descendant · cites it directly · 5 of its ownK162354 Sniper Staple SystemTrilliant Surgical, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK172405 Sniper Staple System, Non-SterileTrilliant Surgical · 2017
- Descendant · 2 generations on · 1 of its ownK163226 EPIC Extremely Small StapleEpic Extremely, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK232905 Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP · 2023
- Descendant · 2 generations on · 0 of its ownK181815 DynaBridgeFusion Orthopedics, LLC · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K162354Sniper Staple SystemTrilliant Surgical, Ltd. · 2017 · cites it directly5descendants
- K172405Sniper Staple System, Non-SterileTrilliant Surgical · 2017 · 2 generations on1descendant
- K163226EPIC Extremely Small StapleEpic Extremely, LLC · 2017 · 2 generations on1descendant
- K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP · 2023 · 2 generations on0descendants
- K181815DynaBridgeFusion Orthopedics, LLC · 2018 · 2 generations on0descendants
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) | K123926 | Metasurg Nitinol Staple Implant | Metasurg | 2013 | — |
| +1 | K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | 2017 | — |
| +2 | K172405 | Sniper Staple System, Non-Sterile | Trilliant Surgical | 2017 | — |
| +2 | K163226 | EPIC Extremely Small Staple | Epic Extremely, LLC | 2017 | — |
| +2 | K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | 2023 | — |
| +2 | K181815 | DynaBridge | Fusion Orthopedics, LLC | 2018 | — |
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 |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 2 | 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? (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 |
|---|---|---|---|
| * | K070031 | Memometal Memory StaplesSummary page 1…accessories (21 CFR 888.3030, Product Code JDR, Class 11) Common Name: Bone Staple Predicate Devices: Memornetal Memory Staples (K07003 1) Biomedical Enterprises, Inc. Memograph Staple (K9937 14) Device Description: The Metasurg… | 2007 |
| * | K993714 | Memograph Staple, Warm SystemSummary page 1…Bone Staple Predicate Devices: Memornetal Memory Staples (K07003 1) Biomedical Enterprises, Inc. Memograph Staple (K9937 14) Device Description: The Metasurg Nitinol Staple Implant is a one piece single use nickel t… | 2000 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162354 | Sniper Staple System | 2017 | 5 |
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 23 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, K162354 (Trilliant Surgical, Ltd., 2017) has gone furthest, with 5 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. 2013, 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 Metasurg Nitinol Staple implant is indicated for fixation and arthrodesis of the
associated bones and joints of the hands and feet.
The Metasurg Nitinol Staple implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123926: Metasurg Nitinol Staple Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123926
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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