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 Dec 31, 2025 as substantially equivalent to K153575 (Tyber Medical, LLC, 2016) and 1 other predicate after a 111-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Dec 31, 2025
- Review
- 111 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K973309 (1998). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK973309 Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewVilex, Inc. · 1998
- 2 generations backK133842 Tyber Medical Trauma ScrewTyber Medical, LLC · 2014
- 1 generation backK153575 Tyber Medical Trauma ScrewTyber Medical, LLC · 2016
- This deviceK252901 Tyber Medical Trauma ScrewTyber Medical, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973309 | Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw | Vilex, Inc. | 1998 | — |
| −2 | K133842 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2014 | — |
| −1 | K153575 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2016 | — |
| 0 (this device) | K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2020 | 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 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? (2)
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 |
|---|---|---|---|
| * | K153575 | Tyber Medical Trauma ScrewSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K153575 Tyber Medical Trauma Screw IHWC I K19297… | 2016 |
| * | K192975 | Tyber Medical Trauma ScrewsSummary page 5…Product Code I K153575 Tyber Medical Trauma Screw IHWC I K192975 Tyber Medical Trauma Screw IHWC Device… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K153575.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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, arthrodesis,
joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the devices. Screws are
intended for single use only. The Tyber Medical Trauma Screws are not for spinal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252901: Tyber Medical Trauma Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252901
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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