510(k) Report

510(k) · Cleared

Cleared

Tyber Medical Trauma Screw

K153575510(k) TraditionalCleared Feb 26, 201673-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tyber Medical, LLC · HWC Screw, Fixation, Bone

Cleared on Feb 26, 2016 as substantially equivalent to K133842 (Tyber Medical, LLC, 2014) after a 73-day review. Its family tree reaches back 2 generations to 1998. 12 later devices descend from it.

Decided
Feb 26, 2016
Review
73 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. 12 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2002: 1 other ancestor2022: 1 descendant cleared2024: 2 descendants cleared2016: 1 descendant cleared2025: 2 descendants cleared2017: 1 descendant cleared2026: 5 descendants clearedReference device: K153180 · Tyber Medical MST Trauma Screw · Tyber Medical, LLC · 2015K973309 · Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw · Vilex, Inc. · 1998K133842 · Tyber Medical Trauma Screw · Tyber Medical, LLC · 20141995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 2 descendants K133842 · Tyber Medical Trauma Screw · Tyber Medical, LLC · 2014K973309 · Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw · Vilex, Inc. · 19980
  1. Root · 2 generations backK973309 Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewVilex, Inc. · 1998
  2. 1 generation backK133842 Tyber Medical Trauma ScrewTyber Medical, LLC · 2014
  3. This deviceK153575 Tyber Medical Trauma ScrewTyber Medical, LLC · 2016
  4. Descendant · cites it directly · 5 of its ownK203595 DynaFuse Fixation SystemMedShape, Inc. · 2022
  5. Descendant · cites it directly · 2 of its ownK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
  6. Descendant · 2 generations on · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
  7. Descendant · 2 generations on · 1 of its ownK242486 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025
  8. Descendant · 2 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

2016: 12017: 12022: 12024: 22025: 22026: 5
2016high 5 (2026) · low 0 (2018)2026

Most influential descendants

Showing 5 of 12 · See all
  • K203595DynaFuse Fixation SystemMedShape, Inc. · 2022 · cites it directly5descendants
  • K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024 · cites it directly2descendants
  • K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · 2 generations on1descendant
  • K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025 · 2 generations on1descendant
  • K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho · 2024 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K973309Vilex Cannulated Bone Screw, Duval Cannulated Bone ScrewVilex, Inc.1998—
−1K133842Tyber Medical Trauma ScrewTyber Medical, LLC2014—
0 (this device)K153575Tyber Medical Trauma ScrewTyber Medical, LLC2016—
+1K203595DynaFuse Fixation SystemMedShape, Inc.2022—
+1K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC2024—
+2K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte…MedShape, Inc.2026—
+2K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC2025—
+2K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
202210
202420
202520
202650
FIG. 1 — Lineage of K153575, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K133842Tyber Medical Trauma Screw
Summary page 4
…tion fastener and Number 21 CFR 888.3040 Classification Panel: Orthopedic Product Code HWC Predicate Devices Tyber Medical Trauma Screw – K133842 Reference Device for Tyber Medical MST Trauma Screw – K153180 surface treatment Device Description General trauma screw f…
Tyber Medical, LLC2014—
†K153180Tyber Medical MST Trauma ScrewTyber Medical, LLC2015—

Also cleared against K133842: 7 other devices →

What descends from it? (12)

See all 12

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K203595DynaFuse Fixation SystemMedShape, Inc.20225
K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242
K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC20161
K252901Tyber Medical Trauma ScrewTyber Medical, LLC20250

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 18 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, K203595 (MedShape, Inc., 2022) has gone furthest, with 5 descendants of its own.
  • 7 other devices also cite its predicate K133842.

How does its category compare?

All HWC devices

HWC 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

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Tyber Medical Trauma Screw is 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 as stated in the FDA summary.

Also cleared against K133842

7 other devices cite the same predicate.

  • K253042Tyber Medical Trauma ScrewTyber Medical, LLC · 2026
  • K220723Hand Trauma Screw SystemSkeletal Dynamics, Inc. · 2022
  • K203595DynaFuse Fixation SystemMedShape, Inc. · 2022
  • K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd. · 2021
  • K192974Tyber Medical Trauma ScrewTyber Medical, LLC · 2020
  • K170571Tyber Medical BioTy (TM) Nanotopography Trauma Screw, TyFix ScrewTyber Medical, LLC · 2017

More from Tyber Medical, LLC

31 FDA decisions under this applicant name. See the company

  • K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
  • K260810Anteralign LS coverplateTyber Medical, LLC · 2026
  • K261060Navigated LLIF Impactable TrackerTyber Medical, LLC · 2026
  • K253042Tyber Medical Trauma ScrewTyber Medical, LLC · 2026
  • K252901Tyber Medical Trauma ScrewTyber Medical, LLC · 2025

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K153575 · printed Nov 5, 2026

Cite this page

510(k) Report. “K153575: Tyber Medical Trauma Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153575

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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