510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Synthes 6.5MM Midfoot Fusion Bolt

K081071510(k) TraditionalCleared May 1, 200816-day reviewClass II21 CFR 888.3040Recalls 1

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

Synthes (Usa) · HWC Screw, Fixation, Bone

Cleared on May 1, 2008 after a 16-day review. The FDA summary names its predicate without a number. 80 later devices descend from it. It has been recalled once.

Decided
May 1, 2008
Review
16 days
Class
Class II
Product code
HWC
Recalls
1
Predicates
0

80 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2020: 8 descendants cleared2009: 2 descendants cleared2019: 8 descendants cleared2010: 2 descendants cleared2012: 2 descendants cleared2017: 3 descendants cleared2021: 7 descendants cleared2018: 4 descendants cleared2026: 7 descendants cleared2022: 6 descendants cleared2015: 4 descendants cleared2013: 1 descendant cleared2024: 8 descendants cleared2023: 12 descendants cleared2025: 5 descendants cleared20052010201520202025
  1. This deviceK081071 Synthes 6.5MM Midfoot Fusion BoltSynthes (Usa) · 2008
  2. Descendant · cites it directly · 63 of its ownK082934 Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009
  3. Descendant · 2 generations on · 56 of its ownK101700 IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · Recalled
  4. Descendant · cites it directly · 34 of its ownK140741 Salvation Beams and Bolts SystemWrightmedicaltechnologyinc · 2014
  5. Descendant · 2 generations on · 24 of its ownK171018 Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC · 2017
  6. Descendant · 3 generations on · 22 of its ownK142581 APTUS Foot SystemMedartis AG · 2015

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

2009: 22010: 22012: 22013: 12014: 12015: 42017: 32018: 42019: 82020: 82021: 72022: 62023: 122024: 82025: 52026: 7
2009high 12 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 80 · See all
  • K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC · 2009 · cites it directly63descendants
  • K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC · 2010 · 2 generations on56descendants
  • 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
  • K142581APTUS Foot SystemMedartis AG · 2015 · 3 generations on22descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K081071Synthes 6.5MM Midfoot Fusion BoltSynthes (Usa)2008—
+1K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC2009—
+2K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC20102
+1K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc2014—
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC2017—
+3K142581APTUS Foot SystemMedartis AG2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201020
201220
201310
201410
201540
201730
201840
201980
202080
202170
202260
2023120
202480
202550
202670
FIG. 1 — Lineage of K081071, 2008–2026Source: 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
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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
*—Synthes 6.5mm Cannulated Screw
Named without a submission number
—

What descends from it? (80)

See all 80

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

NumberDeviceApplicantDecidedDescendants
K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963
K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434
K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195
K182677DynaNail MiniMedShape, Inc.20195
K193366T2 ICFStryker GmbH20201

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 8, 2013Class IIZ-0014-2014Labeling designA post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K082934 (Extremity Medical, LLC, 2009) has gone furthest, with 63 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. 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?

Synthes 6.5mm Midfoot Fusion Bolt is indicated for fracture fixation,

osteotomies, nonunions, and fusions of large bones in the foot and ankle.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

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/K081071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081071: Synthes 6.5MM Midfoot Fusion Bolt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081071

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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