510(k) · Cleared
Recalled · Class II · 2018Tiger Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trilliant Surgical, Ltd. · HWC Screw, Fixation, Bone
Cleared on Aug 4, 2008 after a 67-day review. The FDA summary names its predicate without a number. 37 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 4, 2008
- Review
- 67 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 5
- Predicates
- 0
37 later devices descend from it, 5 citing it directly.
- This deviceK081510 Tiger Cannulated Screw SystemTrilliant Surgical, Ltd. · 2008
- Descendant · cites it directly · 22 of its ownK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 20 of its ownK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 12 of its ownK112737 Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd. · 2011 · Recalled
- Descendant · 3 generations on · 9 of its ownK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 7 of its ownK153338 Tiger Cannulated Screw SystemTrilliant Surgical, Ltd. · 2016 · Recalled
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K122959Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012 · cites it directly22descendants
- K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014 · 2 generations on20descendants
- K112737Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd. · 2011 · cites it directly12descendants
- K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014 · 3 generations on9descendants
- K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd. · 2016 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081510 | Tiger Cannulated Screw System | Trilliant Surgical, Ltd. | 2008 | — |
| +1 | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | 1 |
| +2 | K140148 | Pro-Toe Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K112737 | Tiger Headless Cannulated Screws | Trilliant Surgical, Ltd. | 2011 | 4 |
| +3 | K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K153338 | Tiger Cannulated Screw System | Trilliant Surgical, Ltd. | 2016 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | — | similar previously cleared cannulated screws Named without a submission number |
What descends from it? (37)
See all 375 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2018 | Class II | Z-1605-2020 | Labeling Change Control | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. |
| Jul 20, 2015 | Class II | Z-2464-2015 | Component design/selection | Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray. |
| Jul 20, 2015 | Class II | Z-2421-2015 | Nonconforming Material/Component | The cutting efficiency of the Countersinks was out of specification. |
| Jul 20, 2015 | Class II | Z-2452-2015 | Nonconforming Material/Component | The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through. |
| Apr 14, 2009 | Not classified | Z-1438-2010 | Other | Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122959 (Trilliant Surgical, Ltd., 2012) has gone furthest, with 22 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Tiger Cannulated Screw Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081510: Tiger Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081510
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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