510(k) Report

510(k) · Cleared

Cleared

Micro Osteosynthesis System (1.0)

K944561510(k) TraditionalCleared Oct 18, 199432-day reviewClass II21 CFR 872.4760

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

KLS-Martin L.P. · JEY Plate, Bone

Cleared on Oct 18, 1994 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 450 later devices descend from it.

Decided
Oct 18, 1994
Review
32 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
0

450 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2003: 3 descendants cleared2002: 4 descendants cleared2004: 1 descendant cleared2024: 53 descendants cleared2012: 17 descendants cleared2008: 3 descendants cleared2006: 2 descendants cleared2005: 2 descendants cleared2010: 6 descendants cleared2014: 20 descendants cleared2013: 11 descendants cleared2025: 39 descendants cleared2007: 1 descendant cleared2020: 30 descendants cleared2015: 26 descendants cleared2026: 51 descendants cleared2016: 16 descendants cleared2011: 3 descendants cleared2017: 32 descendants cleared2018: 18 descendants cleared2021: 27 descendants cleared2023: 39 descendants cleared2019: 19 descendants cleared2022: 27 descendants cleared1990200020102020
  1. This deviceK944561 Micro Osteosynthesis System (1.0)KLS-Martin L.P. · 1994
  2. Descendant · cites it directly · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
  3. Descendant · 2 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
  4. Descendant · 3 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
  5. Descendant · 4 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  6. Descendant · 4 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010

Showing 5 of 450 descendants. See all descendants

Descendants cleared per year

2002: 42003: 32004: 12005: 22006: 22007: 12008: 32010: 62011: 32012: 172013: 112014: 202015: 262016: 162017: 322018: 182019: 192020: 302021: 272022: 272023: 392024: 532025: 392026: 51
2002high 53 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 450 · See all
  • K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · cites it directly360descendants
  • K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 2 generations on343descendants
  • K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 3 generations on342descendants
  • K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 4 generations on339descendants
  • K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 4 generations on228descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944561Micro Osteosynthesis System (1.0)KLS-Martin L.P.1994—
+1K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004—
+2K050868MaxlockOrthohelix Surgical Designs, Inc.2005—
+3K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081
+4K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
+4K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200240
200330
200410
200520
200620
200710
200830
201060
201130
2012170
2013110
2014200
2015260
2016160
2017320
2018180
2019190
2020300
2021270
2022270
2023390
2024530
2025390
2026510
FIG. 1 — Lineage of K944561, 1994–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JEY? 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 JEY device

  1. #1 K252246 Leforte MMF Systemscore 15.6 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (450)

See all 450

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

NumberDeviceApplicantDecidedDescendants
K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004360
K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665
K112557Stryker Universal Neuro 3 SystemStryker20129
K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20027
K031989Ortrautek Orthognathic SystemTekka20035
K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241
K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…Bioplate, Inc.20021
K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…Bioplate, Inc.20080
K032520Ortrautek Trauma SystemTekka20030
K023665Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20020

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?

  • Of its descendants, K040598 (KLS-Martin L.P., 2004) has gone furthest, with 360 descendants of its own.

How does its category compare?

All JEY devices

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

FDA decisions per year · JEY

2in 2025

2007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026 (partial year): 3
2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007: 115 days median2008: 84 days median2009: 121 days median2010: 199 days median2011: 75 days median2012: 194 days median2013: 126 days median2014: 223 days median2015: 160 days median2017: 190 days median2018: 255 days median2019: 163 days median2020: 198 days median2021: 299 days median2022: 135 days median2024: 159 days median2026 (partial year): 258 days median
2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2008: 32009: 62010: 852013: 12020: 1
2007high 85 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JEY

1,003in 2025

2007: 292008: 242009: 932010: 2152011: 2412012: 4282013: 7662014: 6162015: 7672016: 5582017: 5682018: 6082019: 5952020: 6802021: 4512022: 3442023: 4952024: 6962025: 1,003
2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, 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
20079115029
2008784324
20094121693
2010619985215
20115750241
2012101940428
201381261766
201462230616
201571600767
20161—0558
201751900568
201872550608
201961630595
202061981680
202142990451
202251350344
20232—0495
202451590696
20252—01,003
202632580—

More from KLS-Martin L.P.

59 FDA decisions under this applicant name. See the company

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253660KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2026
  • K250988KLS Martin Pure Pectus SystemKLS-Martin L.P. · 2025
  • K250865KLS Martin IPS Forearm SystemKLS-Martin L.P. · 2025
  • K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM)…KLS-Martin L.P. · 2025

Recent decisions in JEY

The JEY category page

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025

https://510kreport.com/device/K944561 · printed Nov 6, 2026

Cite this page

510(k) Report. “K944561: Micro Osteosynthesis System (1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944561

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026