510(k) · Cleared
Recalled · Class II · 2018Tiger Headless Cannulated Screws
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 Oct 20, 2011 as substantially equivalent to K081510 (Trilliant Surgical, Ltd., 2008) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 2002. 12 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 20, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K021556 (2002). 3 ancestors in all. 12 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK021556 Synthes 2.4 MM Cannulated Compression ScrewSynthes (Usa) · 2002
- This deviceK112737 Tiger Headless Cannulated ScrewsTrilliant Surgical, Ltd. · 2011
- Descendant · cites it directly · 7 of its ownK153338 Tiger Cannulated Screw SystemTrilliant Surgical, Ltd. · 2016 · Recalled
- Descendant · 2 generations on · 5 of its ownK203595 DynaFuse Fixation SystemMedShape, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK161259 KLS Martin Cannulated Headless ScrewsKLS Martin L.P. · 2016
- Descendant · 3 generations on · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
- Descendant · 3 generations on · 1 of its ownK233567 OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd. · 2016 · cites it directly7descendants
- K203595DynaFuse Fixation SystemMedShape, Inc. · 2022 · 2 generations on5descendants
- K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P. · 2016 · cites it directly2descendants
- K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · 3 generations on1descendant
- K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021556 | Synthes 2.4 MM Cannulated Compression Screw | Synthes (Usa) | 2002 | — |
| 0 (this device) | K112737 | Tiger Headless Cannulated Screws | Trilliant Surgical, Ltd. | 2011 | — |
| +1 | K153338 | Tiger Cannulated Screw System | Trilliant Surgical, Ltd. | 2016 | 4 |
| +2 | K203595 | DynaFuse Fixation System | MedShape, Inc. | 2022 | — |
| +1 | K161259 | KLS Martin Cannulated Headless Screws | KLS Martin L.P. | 2016 | — |
| +3 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte… | MedShape, Inc. | 2026 | — |
| +3 | K233567 | OsteoCoil™ Nitinol Compression System (Multiple Component PNs) | Flower Orthopedics Corporation Dba Conventus Flower Ortho | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K081510 | Tiger Cannulated Screw System | 2008 |
| * | K050636 | Synthes 3.0MM Headless Compression ScrewsSummary page 1…Device panel: Orthopedic Legally Marketed Tiger Cannulated screws (KO81510) Predicate Device: 2.4 and 3.0mm Headless Compression Screws (K050636/K021556) Submitter: Trilliant Surgical LTD 602 Sawyer Street, Suite 120… | 2005 |
| * | K021556 | Synthes 2.4 MM Cannulated Compression ScrewSummary page 1…e panel: Orthopedic Legally Marketed Tiger Cannulated screws (KO81510) Predicate Device: 2.4 and 3.0mm Headless Compression Screws (K050636/K021556) Submitter: Trilliant Surgical LTD 602 Sawyer Street, Suite 120… | 2002 |
What descends from it? (12)
See all 123 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-1606-2020 | 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 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. |
| Sep 2, 2016 | Class II | Z-0609-2017 | Nonconforming Material/Component | Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather… |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Headless Cannulated 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/K112737 · printed Nov 4, 2026
Cite this page
510(k) Report. “K112737: Tiger Headless Cannulated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K112737
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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