510(k) Report

510(k) · Cleared

Cleared

Synthes 2.0 MM Locking Plate System (2.0 LPS)

K974555510(k) TraditionalCleared Mar 3, 199889-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 Mar 3, 1998 as substantially equivalent to K954385 (Synthes (Usa), 1996) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1996. 457 later devices descend from it.

Decided
Mar 3, 1998
Review
89 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K954385 (1996). 3 ancestors in all. 457 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 1 other ancestor2003: 4 descendants cleared2007: 2 descendants cleared2019: 22 descendants cleared2012: 17 descendants cleared2009: 1 descendant cleared2008: 2 descendants cleared2010: 5 descendants cleared2004: 1 descendant cleared2017: 32 descendants cleared2024: 54 descendants cleared2018: 18 descendants cleared2006: 1 descendant cleared2015: 28 descendants cleared2014: 21 descendants cleared2013: 10 descendants cleared2005: 1 descendant cleared2025: 40 descendants cleared2020: 29 descendants cleared2011: 4 descendants cleared2016: 18 descendants cleared2026: 51 descendants cleared2021: 28 descendants cleared2022: 29 descendants cleared2023: 39 descendants clearedK954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 9 descendants3 generations forward: 18 descendants4 generations forward: 22 descendants5 generations forward: 21 descendants6 generations forward: 47 descendants7 generations forward: 113 descendants8 generations forward: 115 descendants9 generations forward: 76 descendants10 generations forward: 21 descendants11 generations forward: 6 descendants12 generations forward: 2 descendants K954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 19960+5+10
  1. Root · 1 generation backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. This deviceK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
  3. Descendant · cites it directly · 444 of its ownK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
  4. Descendant · cites it directly · 435 of its ownK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
  5. Descendant · 2 generations on · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
  6. Descendant · 3 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
  7. Descendant · 4 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled

Showing 5 of 457 descendants. See all descendants

Descendants cleared per year

2003: 42004: 12005: 12006: 12007: 22008: 22009: 12010: 52011: 42012: 172013: 102014: 212015: 282016: 182017: 322018: 182019: 222020: 292021: 282022: 292023: 392024: 542025: 402026: 51
2003high 54 (2024) · low 1 (2004)2026

Most influential descendants

Showing 5 of 457 · See all
  • K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003 · cites it directly444descendants
  • K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003 · cites it directly435descendants
  • K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · 2 generations on360descendants
  • K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 3 generations on343descendants
  • K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 4 generations on342descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K954385Synthes Mandibular Modular Fixation SystemSynthes (Usa)1996—
0 (this device)K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa)1998—
+1K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003—
+1K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003—
+2K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004—
+3K050868MaxlockOrthohelix Surgical Designs, Inc.2005—
+4K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200340
200410
200510
200610
200720
200820
200910
201050
201140
2012170
2013100
2014210
2015280
2016180
2017320
2018180
2019220
2020290
2021280
2022290
2023390
2024540
2025400
2026510
FIG. 1 — Lineage of K974555, 1996–2026Source: 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 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? (3)

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
*K954385Synthes Mandibular Modular Fixation System
Summary page 1
…COMMON OR USUAL Bone Plate and Bone Screw NAME DEVICE Class I, 21 CFR 872.4760 and 872.4880 CLASSIFICATION PREDICATE DEVICE Synthes Mandibular Modular Fixation System (K954385), Synthes 2.4 mm Universal Locking Plate System (K961421), and SMF Ti Alloy Bone Screws (K963546) B DESCRIPTION The 2.0 Locking…
Synthes (Usa)1996—
*K961421Synthes 2.4 MM Universal Locking Plate System
Summary page 1
…ass I, 21 CFR 872.4760 and 872.4880 CLASSIFICATION PREDICATE DEVICE Synthes Mandibular Modular Fixation System (K954385), Synthes 2.4 mm Universal Locking Plate System (K961421), and SMF Ti Alloy Bone Screws (K963546) B DESCRIPTION The 2.0 Locking Plate System consists of five different types of - plates…
Synthes (Usa)1996—
*K963546SMF Titanium (TI) Alloy Bone Screws
Summary page 1
…IFICATION PREDICATE DEVICE Synthes Mandibular Modular Fixation System (K954385), Synthes 2.4 mm Universal Locking Plate System (K961421), and SMF Ti Alloy Bone Screws (K963546) B DESCRIPTION The 2.0 Locking Plate System consists of five different types of - plates and two screws, as follows: 2.0 Straight…
Synthes (Usa)1997—

Also cleared against K954385: 6 other devices →

What descends from it? (457)

See all 457

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

NumberDeviceApplicantDecidedDescendants
K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003444
K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003435
K031989Ortrautek Orthognathic SystemTekka20035
K113567Synthes Matrixmadible Plate and Screw SystemSynthes, Inc.20124
K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190
K071612Modus Trilock 2.0/2.3/2.5Medartis AG20070
K032520Ortrautek Trauma SystemTekka20030

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K030448 (Osteomed LP, 2003) has gone furthest, with 444 descendants of its own.
  • 6 other devices also cite its predicate K954385.

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 2.0 LPS is intended for oral, maxillofacial surgery: trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K954385

6 other devices cite the same predicate.

  • K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC · 2020
  • K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
  • K121574Synthes Matrixmadible Plate and Screw SystemSynthes, Inc. · 2012
  • K072463Satyrne Interflex Mandibular Fixation SystemSatyrne Medical · 2007
  • K992682Modus 2.5 Mandibular Reconstruction SetMedartis AG · 1999
  • K981890Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998

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/K974555 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974555: Synthes 2.0 MM Locking Plate System (2.0 LPS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974555

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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