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 Jan 14, 2016 as substantially equivalent to K081510 (Trilliant Surgical, Ltd., 2008) and 7 other predicates after a 56-day review. Its family tree reaches back 6 generations to 1996. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 14, 2016
- Review
- 56 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 4
- Predicates
- 8
Its longest line of descent runs back 6 generations to K962823 (1996). 28 ancestors in all, the oldest K792022 (1979). 7 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 4 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 3 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 2 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 1 generation backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- This deviceK153338 Tiger Cannulated Screw SystemTrilliant Surgical, Ltd. · 2016
- Descendant · cites it directly · 5 of its ownK203595 DynaFuse Fixation SystemMedShape, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
- Descendant · 2 generations on · 1 of its ownK233567 OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho · 2024
- Descendant · cites it directly · 0 of its ownK260995 DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK260106 OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K203595DynaFuse Fixation SystemMedShape, Inc. · 2022 · cites it directly5descendants
- K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · 2 generations on1descendant
- K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho · 2024 · 2 generations on1descendant
- K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026 · cites it directly0descendants
- K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −5 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −4 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −3 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −2 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −1 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| 0 (this device) | K153338 | Tiger Cannulated Screw System | Trilliant Surgical, Ltd. | 2016 | — |
| +1 | K203595 | DynaFuse Fixation System | MedShape, Inc. | 2022 | — |
| +2 | K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte… | MedShape, Inc. | 2026 | — |
| +2 | K233567 | OsteoCoil™ Nitinol Compression System (Multiple Component PNs) | Flower Orthopedics Corporation Dba Conventus Flower Ortho | 2024 | — |
| +1 | K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026 | — |
| +3 | K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2024 | 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? (8)
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 SystemSummary page 4…21 CFR section 888.3040 Device Panel Orthopedic Primary Predicate Tiger Cannulated Screw System - K081510 / K112737 Device Secondary Predicate Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556 Devic… | 2008 |
| * | K112737 | Tiger Headless Cannulated ScrewsSummary page 4…21 CFR section 888.3040 Device Panel Orthopedic Primary Predicate Tiger Cannulated Screw System - K081510 / K112737 Device Secondary Predicate Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556 Devices… | 2011 |
| * | K962011 | Synthes 7.0/7.3 MM Cannulated ScrewsSummary page 4…imary Predicate Tiger Cannulated Screw System - K081510 / K112737 Device Secondary Predicate Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556 Devices Osteomed ExtremiFix Cannulated Screw System - K063298 / K151021… | 1996 |
| * | K963172 | Synthes Sterile 4.5 MM Cannulated ScrewsSummary page 4…icate Tiger Cannulated Screw System - K081510 / K112737 Device Secondary Predicate Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556 Devices Osteomed ExtremiFix Cannulated Screw System - K063298 / K151021… | 1996 |
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 4…Tiger Cannulated Screw System - K081510 / K112737 Device Secondary Predicate Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556 Devices Osteomed ExtremiFix Cannulated Screw System - K063298 / K151021… | 1996 |
| * | K021556 | Synthes 2.4 MM Cannulated Compression ScrewSummary page 4…Tiger Cannulated Screw System - K081510 / K112737 Device Secondary Predicate Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556 Devices Osteomed ExtremiFix Cannulated Screw System - K063298 / K151021… | 2002 |
| * | K063298 | Osteomed Headless Cannulated Screw SystemSummary page 4…condary Predicate Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556 Devices Osteomed ExtremiFix Cannulated Screw System - K063298 / K151021 The Tiger Cannulated Screw System is a headed and headless, cannulated,… | 2007 |
| * | K151021 | OsteoMed Cannulated Screw SystemSummary page 4…edicate Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556 Devices Osteomed ExtremiFix Cannulated Screw System - K063298 / K151021 The Tiger Cannulated Screw System is a headed and headless, cannulated,… | 2015 |
What descends from it? (7)
3 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-1612-2020 | 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-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. |
| Dec 8, 2016 | Class II | Z-0960-2017 | Under Investigation by firm | Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K203595 (MedShape, Inc., 2022) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K081510.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153338: 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/K153338
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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