510(k) · Cleared
ClearedTyber Medical MST 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 Nov 25, 2015 as substantially equivalent to K133842 (Tyber Medical, LLC, 2014) after a 22-day review. Its family tree reaches back 2 generations to 1998. 2 later devices descend from it.
- Decided
- Nov 25, 2015
- Review
- 22 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973309 (1998). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK973309 Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewVilex, Inc. · 1998
- 1 generation backK133842 Tyber Medical Trauma ScrewTyber Medical, LLC · 2014
- This deviceK153180 Tyber Medical MST Trauma ScrewTyber Medical, LLC · 2015
- Descendant · cites it directly · 1 of its ownK161597 Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK170571 Tyber Medical BioTy (TM) Nanotopography Trauma Screw, TyFix ScrewTyber Medical, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973309 | Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw | Vilex, Inc. | 1998 | — |
| −1 | K133842 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2014 | — |
| 0 (this device) | K153180 | Tyber Medical MST Trauma Screw | Tyber Medical, LLC | 2015 | — |
| +1 | K161597 | Tyber Medical BioTy® Nanotopography Trauma Screw | Tyber Medical, LLC | 2016 | — |
| +2 | K170571 | Tyber Medical BioTy (TM) Nanotopography Trauma Screw, TyFix Screw | Tyber Medical, LLC | 2017 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 22.3 · 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 |
|---|---|---|---|
| * | K133842 | Tyber Medical Trauma ScrewSummary page 4…tion fastener and Number 21 CFR 888.3040 Classification Panel: Orthopedic Product Code HWC Predicate Devices Tyber Medical Trauma Screw – K133842 Device Description General trauma screw for compression and fixation of bone with modified surface t… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161597 | Tyber Medical BioTy® Nanotopography Trauma Screw | 2016 | 1 |
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 17 years and passes through 2 companies; a new generation was cleared every 16.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K161597 (Tyber Medical, LLC, 2016) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K133842.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 MST 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 device. Screws are intended for single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153180 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153180: Tyber Medical MST Trauma Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153180
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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