510(k) Report

510(k) · Cleared

Cleared

Synthes Low Profile Neuro System

K022012510(k) TraditionalCleared Nov 1, 2002134-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

Synthes (Usa) · JEY Plate, Bone

Cleared on Nov 1, 2002 after a 134-day review. The FDA summary names no predicate by number. 17 later devices descend from it.

Decided
Nov 1, 2002
Review
134 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
0

17 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2003: 1 descendant cleared2010: 1 descendant cleared2013: 2 descendants cleared2020: 2 descendants cleared2012: 2 descendants cleared2015: 2 descendants cleared2014: 2 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK022012 Synthes Low Profile Neuro SystemSynthes (Usa) · 2002
  2. Descendant · cites it directly · 12 of its ownK031659 Universal Neuro SystemStryker Instruments · 2003
  3. Descendant · cites it directly · 9 of its ownK112557 Stryker Universal Neuro 3 SystemStryker · 2012
  4. Descendant · 2 generations on · 4 of its ownK120352 Stryker Quikflap Sterile Procedure PackStryker · 2012 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK151387 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS…Stryker · 2015
  6. Descendant · 3 generations on · 2 of its ownK140309 CranioplugOssdsign AB · 2014

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2003: 12010: 12012: 22013: 22014: 22015: 22017: 12018: 12019: 12020: 22023: 12026: 1
2003high 2 (2012) · low 0 (2004)2026

Most influential descendants

Showing 5 of 17 · See all
  • K031659Universal Neuro SystemStryker Instruments · 2003 · cites it directly12descendants
  • K112557Stryker Universal Neuro 3 SystemStryker · 2012 · cites it directly9descendants
  • K120352Stryker Quikflap Sterile Procedure PackStryker · 2012 · 2 generations on4descendants
  • K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker · 2015 · 2 generations on2descendants
  • K140309CranioplugOssdsign AB · 2014 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022012Synthes Low Profile Neuro SystemSynthes (Usa)2002—
+1K031659Universal Neuro SystemStryker Instruments2003—
+1K112557Stryker Universal Neuro 3 SystemStryker2012—
+2K120352Stryker Quikflap Sterile Procedure PackStryker201218
+2K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver…Stryker2015—
+3K140309CranioplugOssdsign AB2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201010
201220
201320
201420
201520
201710
201810
201910
202020
202310
202610
FIG. 1 — Lineage of K022012, 2002–2026Source: 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 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?

The FDA summary names no predicate by number.

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K031659Universal Neuro SystemStryker Instruments200312
K112557Stryker Universal Neuro 3 SystemStryker20129
K123723Synthes Matrixneuro Cranial Plating SystemSynthes20132
K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200
K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190
K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100

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, K031659 (Stryker Instruments, 2003) has gone furthest, with 12 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—

What is it indicated for?

The Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

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 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/K022012 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022012: Synthes Low Profile Neuro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022012

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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