510(k) Report

510(k) · Cleared

Cleared

5TH Metatarsal Fracture Screw

K053136510(k) TraditionalCleared Jan 5, 200657-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

Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone

Cleared on Jan 5, 2006 after a 57-day review. The FDA summary names its predicate without a number. 41 later devices descend from it.

Decided
Jan 5, 2006
Review
57 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

41 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2013: 1 descendant cleared2019: 4 descendants cleared2025: 3 descendants cleared2021: 3 descendants cleared2018: 2 descendants cleared2017: 1 descendant cleared2020: 6 descendants cleared2026: 6 descendants cleared2022: 4 descendants cleared2023: 6 descendants cleared2024: 3 descendants cleared20052010201520202025
  1. This deviceK053136 5TH Metatarsal Fracture ScrewWrightmedicaltechnologyinc · 2006
  2. Descendant · cites it directly · 34 of its ownK140741 Salvation Beams and Bolts SystemWrightmedicaltechnologyinc · 2014
  3. Descendant · 2 generations on · 24 of its ownK171018 Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017
  4. Descendant · 3 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
  5. Descendant · 4 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
  6. Descendant · 5 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2013: 12014: 22017: 12018: 22019: 42020: 62021: 32022: 42023: 62024: 32025: 32026: 6
2013high 6 (2020) · low 0 (2015)2026

Most influential descendants

Showing 5 of 41 · See all
  • K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc · 2014 · cites it directly34descendants
  • K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017 · 2 generations on24descendants
  • K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 3 generations on21descendants
  • K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 4 generations on9descendants
  • K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K0531365TH Metatarsal Fracture ScrewWrightmedicaltechnologyinc2006—
+1K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc2014—
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC2017—
+3K190586Monster® Screw SystemParagon 28, Inc.2019—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH2020—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker…Stryker GmbH2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201710
201820
201940
202060
202130
202240
202360
202430
202530
202660
FIG. 1 — Lineage of K053136, 2006–2026Source: 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
*—Multi-Use Compression Screw
Named without a submission number
—

What descends from it? (41)

See all 41

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

NumberDeviceApplicantDecidedDescendants
K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434
K140952Charlotte Carolina Jones Fracture System ScrewWrightmedicaltechnologyinc20145
K183026Wright Jones Fracture SystemWrightmedicaltechnologyinc20191
K131620Jones-FX Fracture SystemInstratek, Inc.20131

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?

  • Of its descendants, K140741 (Wrightmedicaltechnologyinc, 2014) has gone furthest, with 34 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 5th Metatarsal Fracture Screw is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:

* Fixation of malunions and nonunions

* Acute fractures

* Avulsion fractures

* Repetitive stress fractures

* Jones Fractures

* Malleolar Fractures

* Talus Fractures

* Greater Tuberosity Fractures

Indications for use as stated in the FDA summary.

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311 FDA decisions under this applicant name. See the company

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  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
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https://510kreport.com/device/K053136 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053136: 5TH Metatarsal Fracture Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053136

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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