510(k) · Cleared
ClearedSniper Staple System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trilliant Surgical, Ltd. · JDR Staple, Fixation, Bone
Cleared on Apr 20, 2017 as substantially equivalent to K123926 (Metasurg, 2013) and 1 other predicate after a 240-day review. Its family tree reaches back 4 generations to 1990. 5 later devices descend from it.
- Decided
- Apr 20, 2017
- Review
- 240 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902307 (1990). 6 ancestors in all. 5 later devices descend from it, 5 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 backK123926 Metasurg Nitinol Staple ImplantMetasurg · 2013
- This deviceK162354 Sniper Staple SystemTrilliant Surgical, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK172405 Sniper Staple System, Non-SterileTrilliant Surgical · 2017
- Descendant · cites it directly · 1 of its ownK163226 EPIC Extremely Small StapleEpic Extremely, LLC · 2017
- Descendant · cites it directly · 0 of its ownK232905 Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP · 2023
- Descendant · cites it directly · 0 of its ownK181815 DynaBridgeFusion Orthopedics, LLC · 2018
- Descendant · cites it directly · 0 of its ownK180544 DePuy Synthes Static StaplesSynthes (USA) Products, LLC · 2018
Most influential descendants
Showing 5 of 5 · See all- K172405Sniper Staple System, Non-SterileTrilliant Surgical · 2017 · cites it directly1descendant
- K163226EPIC Extremely Small StapleEpic Extremely, LLC · 2017 · cites it directly1descendant
- K232905Medline UNITE® REFLEX® Nitinol Staple KitMedline Industries, LP · 2023 · cites it directly0descendants
- K181815DynaBridgeFusion Orthopedics, LLC · 2018 · cites it directly0descendants
- K180544DePuy Synthes Static StaplesSynthes (USA) Products, LLC · 2018 · cites it directly0descendants
View 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 | K123926 | Metasurg Nitinol Staple Implant | Metasurg | 2013 | — |
| 0 (this device) | K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | 2017 | — |
| +1 | K172405 | Sniper Staple System, Non-Sterile | Trilliant Surgical | 2017 | — |
| +1 | K163226 | EPIC Extremely Small Staple | Epic Extremely, LLC | 2017 | — |
| +1 | K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | 2023 | — |
| +1 | K181815 | DynaBridge | Fusion Orthopedics, LLC | 2018 | — |
| +1 | K180544 | DePuy Synthes Static Staples | Synthes (USA) Products, LLC | 2018 | — |
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 |
|---|---|---|
| 2017 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K123926 | Metasurg Nitinol Staple ImplantSummary page 4…21 CFR section 888.3030 Device Panel Orthopedic Primary Predicate MemoFix Super Elastic Nitinol Staple System (Metasurg (Integra), K123926) Device Secondary Predicate Super Staple Classic (Metric Medical Devices, K123363) Devices Smit… | 2013 |
| * | K123363 | Super Staple (TM) ClassicSummary page 4…dicate MemoFix Super Elastic Nitinol Staple System (Metasurg (Integra), K123926) Device Secondary Predicate Super Staple Classic (Metric Medical Devices, K123363) Devices Smith and Nephew Richards Staple, (pre-amendment device) The Sni… | 2013 |
| * | — | Smith and Nephew Richards Staple Named without a submission number |
What descends from it? (5)
5 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 27 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K172405 (Trilliant Surgical, 2017) has gone furthest, with 1 descendant 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. 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?
The Trilliant Surgical Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.
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/K162354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162354: Sniper Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162354
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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