510(k) Report

510(k) · Cleared

Cleared

Darco Force Titanium Compression Screw

K062103510(k) TraditionalCleared Oct 25, 200693-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

Darco International, Inc. · HWC Screw, Fixation, Bone

Cleared on Oct 25, 2006 as substantially equivalent to K042079 (O.M.T. Oberflachen-Und Materialtechnologie GmbH, 2004) after a 93-day review. Its family tree reaches back 1 generation to 2004. 49 later devices descend from it.

Decided
Oct 25, 2006
Review
93 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K042079 (2004). 49 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 5 descendants cleared2013: 2 descendants cleared2014: 2 descendants cleared2012: 3 descendants cleared2010: 1 descendant cleared2017: 6 descendants cleared2015: 5 descendants cleared2016: 3 descendants cleared2018: 2 descendants cleared2025: 4 descendants cleared2020: 2 descendants cleared2024: 1 descendant cleared2021: 3 descendants cleared2023: 1 descendant cleared2022: 3 descendants cleared2026: 5 descendants clearedK042079 · Oss/(Scarf)- and Osw-Screw · O.M.T. Oberflachen-Und Materialtechnologie GmbH · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 11 descendants3 generations forward: 18 descendants4 generations forward: 12 descendants5 generations forward: 6 descendants6 generations forward: 1 descendant K042079 · Oss/(Scarf)- and Osw-Screw · O.M.T. Oberflachen-Und Materialtechnologie GmbH · 20040+5
  1. Root · 1 generation backK042079 Oss/(Scarf)- and Osw-ScrewO.M.T. Oberflachen-Und Materialtechnologie GmbH · 2004
  2. This deviceK062103 Darco Force Titanium Compression ScrewDarco International, Inc. · 2006
  3. Descendant · cites it directly · 48 of its ownK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
  4. Descendant · 2 generations on · 9 of its ownK112727 Medical Facets Corical Screws, Medical Facets Cancellous Screws…Medical Facets · 2012
  5. Descendant · 2 generations on · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
  6. Descendant · 2 generations on · 8 of its ownK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
  7. Descendant · 2 generations on · 5 of its ownK132820 Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 52012: 32013: 22014: 22015: 52016: 32017: 62018: 22020: 22021: 32022: 32023: 12024: 12025: 42026: 5
2009high 6 (2017) · low 0 (2019)2026

Most influential descendants

Showing 5 of 49 · See all
  • K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH · 2009 · cites it directly48descendants
  • K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets · 2012 · 2 generations on9descendants
  • K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · 2 generations on8descendants
  • K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011 · 2 generations on8descendants
  • K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K042079Oss/(Scarf)- and Osw-ScrewO.M.T. Oberflachen-Und Materialtechnologie GmbH2004—
0 (this device)K062103Darco Force Titanium Compression ScrewDarco International, Inc.2006—
+1K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH2009—
+2K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical…Medical Facets2012—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited2011—
+2K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH2011—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201150
201230
201320
201420
201550
201630
201760
201820
202020
202130
202230
202310
202410
202540
202650
FIG. 1 — Lineage of K062103, 2004–2026Source: 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
*K042079Oss/(Scarf)- and Osw-Screw
Summary page 1
…cation Name: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) Legally Marketed Predicate Device: OM.T. Scarf Screw (K042079) Device Description: The DARCO Force Compression Screw is a self drilling, self tapping and self cou…
O.M.T. Oberflachen-Und Materialtechnologie GmbH2004—

What descends from it? (49)

See all 49

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948

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?

  • Its one ancestor has no recall.
  • Of its descendants, K083912 (Treu-Instrumente GmbH, 2009) has gone furthest, with 48 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 DARCO Force Titanium Compression Screw is to be used on indications that are common for currently marketed compression screws. The primary indication for use is the fixation and stabilization of the fractures and non-unions of small bones and small bone arthrodeses including but not limited to intra-articular fractures of the tarsals, metatarsal, carpals and metacarpals, bunionectomies and osteotomies, arthrodesis of small joints (e.g. phalanges).

Indications for use as stated in the FDA summary.

More from Darco International, Inc.

2 FDA decisions under this applicant name. See the company

  • K061808Darco Locking Bone Plate SystemDarco International, Inc. · 20063 recalls

Recent decisions in HWC

The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K062103 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062103: Darco Force Titanium Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062103

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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