510(k) Report

510(k) · Cleared

Cleared

Osteomed Extremifuse System

K140283510(k) SpecialCleared Feb 28, 201424-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

Osteomed · HWC Screw, Fixation, Bone

Cleared on Feb 28, 2014 as substantially equivalent to K130412 (Osteomed, 2013) and 3 other predicates after a 24-day review. Its family tree reaches back 4 generations to 2002.

Decided
Feb 28, 2014
Review
24 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K013888 (2002). 13 ancestors in all, the oldest K954330 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2009: 1 other ancestor2010: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1996: 2 other ancestors1995: 1 other ancestor1998: 1 other ancestorK013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 2002K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 2003K062863 · Osteomed Extended 2.0/2.4CANNULATED Screw System · Osteomed LP · 2006K111536 · Metasurg Digifuse Implant · Metasurg · 201119952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 2 other ancestors K111536 · Metasurg Digifuse Implant · Metasurg · 2011K062863 · Osteomed Extended 2.0/2.4CANNULATED Screw System · Osteomed LP · 2006K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 2003K013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 20020
  1. Root · 4 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
  2. 3 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
  3. 2 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
  4. 1 generation backK111536 Metasurg Digifuse ImplantMetasurg · 2011
  5. This deviceK140283 Osteomed Extremifuse SystemOsteomed · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K013888Fixation (Steinmann) PinsMiltex, Inc.2002—
−3K031050PCW Percutaneous Compression WireMillennium Medical Technologies, Inc.2003—
−2K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP2006—
−1K111536Metasurg Digifuse ImplantMetasurg2011—
0 (this device)K140283Osteomed Extremifuse SystemOsteomed2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199620
199810
200110
200210
200910
201010
201310
FIG. 1 — Lineage of K140283, 2002–2014Source: 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
*K130412Osteomed Extremifuse System
Summary page 1
…" Product Code: o HWC Device Class: 11 Predicate Devices: OsteoMed ExtremiFuse System. K130412 Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888…
Osteomed2013—
*K111536Metasurg Digifuse Implant
Summary page 1
…lic bone fixation fastener (21CFR 888.3040, Product Code HWC) Device Class: 11 Metasurg DigiFuse System. K1 11536 Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888.…
Metasurg2011—
*K091614Osteomed Foot Plating System
Summary page 1
…(21CFR 888.3040, Product Code IIWC) Device Class: HI OsteoMed Foot Plate and Screw Rigid Fixation System. K091614 Classification Name: Single/multiple component metallic bone fixation appliances…
Osteomed LP2009—
*K062863Osteomed Extended 2.0/2.4CANNULATED Screw System
Summary page 2
…e 2 === K(140283 Pg. 2/3 OsteoMed Extended 2.0/2.4 Cannulated Screw System. K062863 Classification Name: Smooth or threaded metallic bone fixation fastener (21ICFR 8…
Osteomed LP2006—

Also cleared against K130412: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 12 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
  • None of the 13 ancestors has a recall.
  • 1 other device also cites its predicate K130412.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Indications for use as stated in the FDA summary.

Also cleared against K130412

1 other device cites the same predicate.

  • K133515Peek Fusion ImplantMtp Solutions, LLC · 2014

More from Osteomed

12 FDA decisions under this applicant name. See the company

  • K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed · 2021
  • K162542OsteoMed PINNACLE DriverOsteomed · 2017
  • K162544OsteoMed PINNACLE DriverOsteomed · 2017
  • K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2016
  • K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed · 2015

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/K140283 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140283: Osteomed Extremifuse System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140283

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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