510(k) Report

510(k) · Cleared

Recalled · Class II · 2010

Maxtorque Mini Cannulated Screw System

K082574510(k) SpecialCleared Dec 8, 200894-day reviewClass II21 CFR 888.3040Recalls 3

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

Orthohelix Surgical Designs, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 8, 2008 as substantially equivalent to K060428 (Orthohelix Surgical Designs, Inc., 2006) and 2 other predicates after a 94-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it. It has been recalled 3 times.

Decided
Dec 8, 2008
Review
94 days
Class
Class II
Product code
HWC
Recalls
3
Predicates
3

Its longest line of descent runs back 2 generations to K000080 (2000). 8 ancestors in all, the oldest K962823 (1996). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2002: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestor1996: 1 other ancestor2013: 1 descendant cleared2018: 1 descendant cleared2015: 1 descendant clearedK000080 · Asnis Iii Cannulated Screw System · Howmedica Osteonics Corp. · 2000 · recalledK060428 · CSS Cannulated Screw System · Orthohelix Surgical Designs, Inc. · 2006 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K060428 · CSS Cannulated Screw System · Orthohelix Surgical Designs, Inc. · 2006 · recalledK000080 · Asnis Iii Cannulated Screw System · Howmedica Osteonics Corp. · 2000 · recalled0
  1. Root · 2 generations backK000080 Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp. · 2000 · Recalled
  2. 1 generation backK060428 CSS Cannulated Screw SystemOrthohelix Surgical Designs, Inc. · 2006 · Recalled
  3. This deviceK082574 Maxtorque Mini Cannulated Screw SystemOrthohelix Surgical Designs, Inc. · 2008
  4. Descendant · cites it directly · 2 of its ownK131324 Maxtorque Screw SystemOrthohelix Surgical Designs, Inc. · 2013
  5. Descendant · cites it directly · 0 of its ownK182989 AURORA™ Screw SystemMiRus, LLC · 2018
  6. Descendant · 2 generations on · 0 of its ownK150871 ForeFoot STP SystemTornier, Inc. · 2015

Most influential descendants

Showing 3 of 3 · See all
  • K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc. · 2013 · cites it directly2descendants
  • K182989AURORA™ Screw SystemMiRus, LLC · 2018 · cites it directly0descendants
  • K150871ForeFoot STP SystemTornier, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K000080Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp.20001
−1K060428CSS Cannulated Screw SystemOrthohelix Surgical Designs, Inc.20064
0 (this device)K082574Maxtorque Mini Cannulated Screw SystemOrthohelix Surgical Designs, Inc.2008—
+1K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.2013—
+1K182989AURORA™ Screw SystemMiRus, LLC2018—
+2K150871ForeFoot STP SystemTornier, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199920
200210
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201810
FIG. 1 — Lineage of K082574, 2000–2018Source: 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? (4)

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
*K060428CSS Cannulated Screw System
Summary page 2
…t to design, intended use, performance and operational principle as internal fixation components. Predicate systems considered are the MaxTorque Cannulated Screw System (K060428) and Asnis Cannulated Screw System (K000080, and K071092). The subject MaxTorque TM Mini Cannulated Screws are a modificatio…
Orthohelix Surgical Designs, Inc.20064
*K000080Asnis Iii Cannulated Screw System
Summary page 2
…perational principle as internal fixation components. Predicate systems considered are the MaxTorque Cannulated Screw System (K060428) and Asnis Cannulated Screw System (K000080, and K071092). The subject MaxTorque TM Mini Cannulated Screws are a modification to the MaxTorque Cannulated Screw System c…
Howmedica Osteonics Corp.20001
*K071092Asnis Micro Cannulated Screw
Summary page 2
…inciple as internal fixation components. Predicate systems considered are the MaxTorque Cannulated Screw System (K060428) and Asnis Cannulated Screw System (K000080, and K071092). The subject MaxTorque TM Mini Cannulated Screws are a modification to the MaxTorque Cannulated Screw System cleared in K06…
Howmedica Osteonics Corp.2007—
*—CSS Cannulated Screw System
Named without a submission number
—

Also cleared against K060428: 3 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132
K182989AURORA™ Screw SystemMiRus, LLC20180

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 29, 2010Class IIZ-0026-2013Software design (manufacturing process)The tips of the drivers are breaking while being used to drive the screws into patients.
Jan 29, 2010Class IIZ-0027-2013Software design (manufacturing process)The tips of the drivers are breaking while being used to drive the screws into patients.
Sep 3, 2009Not classifiedZ-1430-2010Nonconforming Material/ComponentThe epoxy is flaking off the drill bits and countersinks.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K131324 (Orthohelix Surgical Designs, Inc., 2013) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K060428.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 MaxTorqueT M Cannulated Screw System is indicated for use in long and small bone fracture fixation, which includes the following:

* Fractures of the tarsals and metatarsals

* Fractures of the olecranon, distal humerus

* Fractures of the radius and ulna

· Patellar fractures

* Distal tibia and pilon fractures

· Fractures of the fibula, medial malleolus, or calcis

* Tarso-metatarsal and metatarsal-phalangeal Arthrodesis

· Metatarsal and Phalangeal osteotomies

· Osteochondritis dissecans

* Ligament fixation

· Other small fragment, cancellous bone fractures and osteotomies

Indications for use as stated in the FDA summary.

Also cleared against K060428

3 other devices cite the same predicate.

  • K182989AURORA™ Screw SystemMiRus, LLC · 2018
  • K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc. · 2013
  • K124027Monster Screw SystemApogee Orthosolutions · 2013

More from Orthohelix Surgical Designs, Inc.

25 FDA decisions under this applicant name. See the company

  • K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2014
  • K142148Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2014
  • K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc. · 2014
  • K132733Orthohelix Syndesmosis Fixation DevicesOrthohelix Surgical Designs, Inc. · 2014
  • K132591Maxlock Extreme SystemOrthohelix Surgical Designs, Inc. · 2013

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/K082574 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082574: Maxtorque Mini Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082574

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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