510(k) · Cleared
ClearedSniper Staple System, Non-Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trilliant Surgical · JDR Staple, Fixation, Bone
Cleared on Dec 11, 2017 as substantially equivalent to K162354 (Trilliant Surgical, Ltd., 2017) after a 124-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Dec 11, 2017
- Review
- 124 days
- Class
- Class II
- Product code
- JDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902307 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
- 4 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
- 3 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
- 2 generations backK123926 Metasurg Nitinol Staple ImplantMetasurg · 2013
- 1 generation backK162354 Sniper Staple SystemTrilliant Surgical, Ltd. · 2017
- This deviceK172405 Sniper Staple System, Non-SterileTrilliant Surgical · 2017
- Descendant · cites it directly · 0 of its ownK181815 DynaBridgeFusion Orthopedics, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K181815DynaBridgeFusion Orthopedics, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902307 | Shaw II Hemostatic Surgery System | Hemostatic Surgery Corp. | 1990 | 2 |
| −4 | K993714 | Memograph Staple, Warm System | Biomedical Ent., Inc. | 2000 | — |
| −3 | K070031 | Memometal Memory Staples | Memometal Technologies | 2007 | — |
| −2 | K123926 | Metasurg Nitinol Staple Implant | Metasurg | 2013 | — |
| −1 | K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | 2017 | — |
| 0 (this device) | K172405 | Sniper Staple System, Non-Sterile | Trilliant Surgical | 2017 | — |
| +1 | K181815 | DynaBridge | Fusion Orthopedics, 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 |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K162354 | Sniper Staple SystemSummary page 4…JDR CFR Section 21 CFR Section 888.3030 Device Panel Orthopedic Predicate Device Sniper Staple System, Sterile (Trilliant Surgical LTD, K162354) II. DEVICE DESCRIPTION The Sniper Staple System consists of different-sized staples composed of Nitinol (Ni… | 2017 |
| † | K081510 | Tiger Cannulated Screw System | 2008 |
| † | K121452 | Gridlock Plating System | 2012 |
| † | K153338 | Tiger Cannulated Screw System | 2016 |
| † | K123926 | Metasurg Nitinol Staple Implant | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181815 | DynaBridge | 2018 | 0 |
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 6 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K181815 (Fusion Orthopedics, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K162354.
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 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/K172405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172405: Sniper Staple System, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172405
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