510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Darco Locking Bone Plate System

K061808510(k) TraditionalCleared Aug 17, 200651-day reviewClass II21 CFR 888.3030Recalls 3

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

Darco International, Inc. · HRS Plate, Fixation, Bone

Cleared on Aug 17, 2006 as substantially equivalent to K022325 (Osteomedics, Inc., 2002) after a 51-day review. Its family tree reaches back 1 generation to 2002. 410 later devices descend from it. It has been recalled 3 times.

Decided
Aug 17, 2006
Review
51 days
Class
Class II
Product code
HRS
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K022325 (2002). 410 later devices descend from it, 24 citing it directly.

Descendants, by year cleared 2016: 17 descendants cleared2022: 25 descendants cleared2010: 8 descendants cleared2017: 36 descendants cleared2014: 19 descendants cleared2009: 2 descendants cleared2012: 18 descendants cleared2020: 30 descendants cleared2011: 3 descendants cleared2008: 2 descendants cleared2015: 32 descendants cleared2007: 1 descendant cleared2013: 11 descendants cleared2018: 17 descendants cleared2019: 23 descendants cleared2023: 32 descendants cleared2021: 26 descendants cleared2024: 42 descendants cleared2025: 26 descendants cleared2026: 40 descendants clearedK022325 · Normed Titanium Osteotomy Plating System · Osteomedics, Inc. · 2002 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 24 descendants2 generations forward: 75 descendants3 generations forward: 138 descendants4 generations forward: 100 descendants5 generations forward: 48 descendants6 generations forward: 17 descendants7 generations forward: 5 descendants8 generations forward: 3 descendants K022325 · Normed Titanium Osteotomy Plating System · Osteomedics, Inc. · 2002 · recalled0+5
  1. Root · 1 generation backK022325 Normed Titanium Osteotomy Plating SystemOsteomedics, Inc. · 2002 · Recalled
  2. This deviceK061808 Darco Locking Bone Plate SystemDarco International, Inc. · 2006
  3. Descendant · cites it directly · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
  4. Descendant · 2 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  5. Descendant · cites it directly · 256 of its ownK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
  6. Descendant · cites it directly · 241 of its ownK090063 Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009
  7. Descendant · cites it directly · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010

Showing 5 of 410 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 22010: 82011: 32012: 182013: 112014: 192015: 322016: 172017: 362018: 172019: 232020: 302021: 262022: 252023: 322024: 422025: 262026: 40
2007high 42 (2024) · low 1 (2007)2026

Most influential descendants

Showing 5 of 410 · See all
  • K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · cites it directly342descendants
  • K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 2 generations on339descendants
  • K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008 · cites it directly256descendants
  • K090063Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009 · cites it directly241descendants
  • K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · cites it directly228descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K022325Normed Titanium Osteotomy Plating SystemOsteomedics, Inc.20021
0 (this device)K061808Darco Locking Bone Plate SystemDarco International, Inc.2006—
+1K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081
+2K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
+1K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008—
+1K090063Merete Locking Bone Plate SystemMerete Medical, Inc.2009—
+1K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200920
201080
201130
2012180
2013110
2014190
2015320
2016170
2017360
2018170
2019230
2020300
2021260
2022250
2023320
2024420
2025260
2026400
FIG. 1 — Lineage of K061808, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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
*K022325Normed Titanium Osteotomy Plating System
Summary page 1
…e component metallic bone fixation appliance (per 2] CFR 888.3030) Legally Marketed Predicate Device: Normed Titanium Osteotomy Plating System (K022325) Device Description: The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of…
Osteomedics, Inc.20021

Also cleared against K022325: 4 other devices →

What descends from it? (410)

See all 410

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

NumberDeviceApplicantDecidedDescendants
K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.2008342
K081513Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH2008256
K090063Merete Locking Bone Plate SystemMerete Medical, Inc.2009241
K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228
K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295
K083447Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50Memometal Technologies200992
K120359Ortholoc 3DI Hallux SystemWrightmedicaltechnologyinc201284
K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited201258
K092528Biomet Forerunner Locking Plate SystemBiomet Trauma (Aka Ebi, Lp)201053
K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited201428

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 9, 2022Class IIZ-0679-2022Packaging process controlProduct was labelled with the incorrect manufacturing and distribution dates.
Dec 3, 2021Class IIZ-0393-2022Under Investigation by firmThe incorrect product is contained in the packaging.
Nov 8, 2016Class IIZ-0573-2020Process controlThe firm discovered a lack of adequate documentation confirming sterility on certain products.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K073624 (Orthohelix Surgical Designs, Inc., 2008) has gone furthest, with 342 descendants of its own.
  • 4 other devices also cite its predicate K022325.

How does its category compare?

All HRS devices

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

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The DARCO Locking Bone Plate System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.

Indications for use as stated in the FDA summary.

Also cleared against K022325

4 other devices cite the same predicate.

  • K151407RECON systemNormed Medizin-Technik GmbH · 2015
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 20121 recall
  • K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004

More from Darco International, Inc.

2 FDA decisions under this applicant name. See the company

  • K062103Darco Force Titanium Compression ScrewDarco International, Inc. · 2006

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K061808 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061808: Darco Locking Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061808

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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