510(k) · Cleared
ClearedTyber Medical Trauma Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyber Medical, LLC · HWC Screw, Fixation, Bone
Cleared on Mar 20, 2014 as substantially equivalent to K082320 (Wrightmedicaltechnologyinc, 2008) and 2 other predicates after a 92-day review. Its family tree reaches back 1 generation to 1998. 23 later devices descend from it.
- Decided
- Mar 20, 2014
- Review
- 92 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K973309 (1998). 3 ancestors in all. 23 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK973309 Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewVilex, Inc. · 1998
- This deviceK133842 Tyber Medical Trauma ScrewTyber Medical, LLC · 2014
- Descendant · cites it directly · 12 of its ownK153575 Tyber Medical Trauma ScrewTyber Medical, LLC · 2016
- Descendant · cites it directly · 5 of its ownK203595 DynaFuse Fixation SystemMedShape, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK213596 OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK231272 OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw…OSSIO, Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K153575Tyber Medical Trauma ScrewTyber Medical, LLC · 2016 · cites it directly12descendants
- K203595DynaFuse Fixation SystemMedShape, Inc. · 2022 · cites it directly5descendants
- K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021 · cites it directly4descendants
- K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd. · 2023 · 2 generations on3descendants
- K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973309 | Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw | Vilex, Inc. | 1998 | — |
| 0 (this device) | K133842 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2014 | — |
| +1 | K153575 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2016 | — |
| +1 | K203595 | DynaFuse Fixation System | MedShape, Inc. | 2022 | — |
| +1 | K213596 | OSSIOfiber Compression Screw, 3.5mm | OSSIO, Ltd. | 2021 | — |
| +2 | K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber®… | OSSIO, Ltd. | 2023 | — |
| +2 | K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K082320 | Darco Small ScrewSummary page 1…ic bone fixation fastener (21 CFR 888.3040) and Number Product Code HWC Predicate Devices 1. WRIGHT COMPRESSION SCREWS; Wright Medical - K(082320 2. HEADLESS COMPRESSION SCREW; Synthes - K(02 1556 3. VILEX/DUAL… | 2008 |
| * | K021556 | Synthes 2.4 MM Cannulated Compression Screw | 2002 |
| * | K973309 | Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewSummary page 1…K(082320 2. HEADLESS COMPRESSION SCREW; Synthes - K(02 1556 3. VILEX/DUAL CANNULATED BONE SCREW; Vilex - K973309 Device Description General trauma screw for compression and fixation of bone. The sterile and… | 1998 |
What descends from it? (23)
See all 238 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153575 | Tyber Medical Trauma Screw | 2016 | 12 |
| K203595 | DynaFuse Fixation System | 2022 | 5 |
| K213596 | OSSIOfiber Compression Screw, 3.5mm | 2021 | 4 |
| K153180 | Tyber Medical MST Trauma Screw | 2015 | 2 |
| K220723 | Hand Trauma Screw System | 2022 | 1 |
| K192974 | Tyber Medical Trauma Screw | 2020 | 1 |
| K253042 | Tyber Medical Trauma Screw | 2026 | 0 |
| K170571 | Tyber Medical BioTy (TM) Nanotopography Trauma Screw, TyFix Screw | 2017 | 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?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, artkirodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133842: Tyber Medical Trauma Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133842
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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