510(k) Report

510(k) · Cleared

Cleared

Synthes Dentoalveolar Bone Fixation System

K102656510(k) TraditionalCleared Dec 20, 201096-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 Dec 20, 2010 as substantially equivalent to K980199 (Synthes (Usa), 1998) and 5 other predicates after a 96-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.

Decided
Dec 20, 2010
Review
96 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K953806 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2002: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor2019: 1 descendant clearedK953806 · Synthes (Usa) Midfacial System · Synthes (Usa) · 1996K980199 · Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws · Synthes (Usa) · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K980199 · Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws · Synthes (Usa) · 1998K953806 · Synthes (Usa) Midfacial System · Synthes (Usa) · 19960
  1. Root · 2 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
  2. 1 generation backK980199 Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and ScrewsSynthes (Usa) · 1998
  3. This deviceK102656 Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa) · 2010
  4. Descendant · cites it directly · 0 of its ownK192655 Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K953806Synthes (Usa) Midfacial SystemSynthes (Usa)1996—
−1K980199Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and ScrewsSynthes (Usa)1998—
0 (this device)K102656Synthes Dentoalveolar Bone Fixation SystemSynthes (Usa)2010—
+1K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199910
200210
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K102656, 1996–2019Source: 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? (6)

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
*K980199Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws
Summary page 1
…Fll 872.4880 Product Codes Primary: JEY Subsequent: DZL Predicate Devices * Synthes l.Smm/2.Omm Orthognathic Maxillary Plates and Screws (K980199) * Synthes 1.3 mm Self-Drilling Screw (K983485) * Osteo-Mesh TM-300 (K984230)…
Synthes (Usa)1998—
*K983485Synthes 1.3 MM Self-Drilling Screw
Summary page 1
…bsequent: DZL Predicate Devices * Synthes l.Smm/2.Omm Orthognathic Maxillary Plates and Screws (K980199) * Synthes 1.3 mm Self-Drilling Screw (K983485) * Osteo-Mesh TM-300 (K984230) * Synthes Craniofacial Plates (K02 1642)…
Synthes (Usa)1998—
*K984230Osteo-Mesh TM-300
Summary page 1
…/2.Omm Orthognathic Maxillary Plates and Screws (K980199) * Synthes 1.3 mm Self-Drilling Screw (K983485) * Osteo-Mesh TM-300 (K984230) * Synthes Craniofacial Plates (K02 1642) a Synthes Poly (L-Lactide-Co-Glycolide) Res…
Osteogenics Biomedical, Inc.1999—
*K021642Synthes Craniofacial Plates
Summary page 1
…* Synthes 1.3 mm Self-Drilling Screw (K983485) * Osteo-Mesh TM-300 (K984230) * Synthes Craniofacial Plates (K02 1642) a Synthes Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System (K030069)…
Synthes (Usa)2002—
*K030069Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation System
Summary page 1
…* Synthes Craniofacial Plates (K02 1642) a Synthes Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System (K030069) * 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates (K03312 1) Device The Synthes Dentoalv…
Synthes (Usa)20033
*K0331211.3 & 1.5MM Contourable Titanium (TI.) Mesh Plates
Summary page 1
…s Poly (L-Lactide-Co-Glycolide) Resorbable Fixation System (K030069) * 1.3 & 1.5mm Contourable Titanium (Ti.) Mesh Plates (K03312 1) Device The Synthes Dentoalveolar Bone Fixation System is a plate, mesh, and screw Description system inten…
Synthes (Usa)2003—

Also cleared against K980199: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190

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?

  • The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 12.7 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K192655 (Synthes (USA) Products, LLC, 2019) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K980199.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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 Dentoalveolar Bone Fixation System is intended for use in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in reconstruction of maxillary and/or mandibular areas, including the dentoalveolar ridge.

Indications for use as stated in the FDA summary.

Also cleared against K980199

2 other devices cite the same predicate.

  • K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
  • K021618Osa Rigid Internal Fixation SystemOsteomed Corp. · 2002

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/K102656 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102656: Synthes Dentoalveolar Bone Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102656

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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