510(k) Report

510(k) · Cleared

Cleared

Vazquez Diner Intraoral Distraction Device

K964649510(k) TraditionalCleared Jan 24, 199765-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

Howmedica Leibinger, Inc. · JEY Plate, Bone

Cleared on Jan 24, 1997 as substantially equivalent to K945674 (Howmedica Corp., 1995) and 3 other predicates after a 65-day review. Its family tree reaches back 2 generations to 1979. 17 later devices descend from it.

Decided
Jan 24, 1997
Review
65 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K792561 (1979). 5 ancestors in all. 17 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors1992: 1 other ancestor2010: 1 descendant cleared1997: 3 descendants cleared1999: 1 descendant cleared2002: 2 descendants cleared2005: 1 descendant cleared2012: 1 descendant cleared2014: 2 descendants cleared1998: 1 descendant cleared2003: 2 descendants cleared2006: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant clearedK792561 · Mini-H-Fixation · Geny Medical, Inc. · 1979K962272 · Synthes Mandible Distractor · Synthes (Usa) · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 8 descendants3 generations forward: 4 descendants K962272 · Synthes Mandible Distractor · Synthes (Usa) · 1996K792561 · Mini-H-Fixation · Geny Medical, Inc. · 19790
  1. Root · 2 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
  2. 1 generation backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
  3. This deviceK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
  4. Descendant · cites it directly · 11 of its ownK972166 Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
  5. Descendant · cites it directly · 8 of its ownK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
  6. Descendant · cites it directly · 7 of its ownK990944 Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999
  7. Descendant · cites it directly · 6 of its ownK013618 Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002
  8. Descendant · 2 generations on · 5 of its ownK043434 Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1997: 31998: 11999: 12002: 22003: 22005: 12006: 12010: 12012: 12014: 22018: 12019: 1
1997high 3 (1997) · low 0 (2000)2026

Most influential descendants

Showing 5 of 17 · See all
  • K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997 · cites it directly11descendants
  • K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997 · cites it directly8descendants
  • K990944Osteomed Intraoral Distraction SystemOsteomed Corp. · 1999 · cites it directly7descendants
  • K013618Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002 · cites it directly6descendants
  • K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP · 2005 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K792561Mini-H-FixationGeny Medical, Inc.1979—
−1K962272Synthes Mandible DistractorSynthes (Usa)1996—
0 (this device)K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc.1997—
+1K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc.1997—
+1K972154Cohen DistractorHowmedica Leibinger, Inc.1997—
+1K990944Osteomed Intraoral Distraction SystemOsteomed Corp.1999—
+1K013618Intraoral Mandibular Distraction SystemOsteomed Corp.2002—
+2K043434Osteomed Pediatric Intraoral Mandibular Distraction SystemOsteomed LP2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199730
199810
199910
200220
200320
200510
200610
201010
201210
201420
201810
201910
FIG. 1 — Lineage of K964649, 1979–2019Source: 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? (4)

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
*K945674Mandibular Bone Distractor
Summary page 1
…ingle use. Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Mandibular Bone Lengthener (K945674), the Wells Johnson Fixation System (8945500), the Synthes Mim Lengthening Apparatus (K914558) and the Synthes Mandible Distracto…
Howmedica Corp.1995—
*K945500Wells Johnson Fixation System
Summary page 1
…ed on similarities in intended use, material, design and operational principle to the Howmedica Mandibular Bone Lengthener (K945674), the Wells Johnson Fixation System (8945500), the Synthes Mim Lengthening Apparatus (K914558) and the Synthes Mandible Distractor (K962272). Each of these devices is intende…
Wells Johnson Co.1995—
*K914558Traumafix (TM) External Fixator
Summary page 1
…sign and operational principle to the Howmedica Mandibular Bone Lengthener (K945674), the Wells Johnson Fixation System (8945500), the Synthes Mim Lengthening Apparatus (K914558) and the Synthes Mandible Distractor (K962272). Each of these devices is intended for use as a mandibular bone lengthener and 1s…
Synthes (Usa)1992—
*K962272Synthes Mandible Distractor
Summary page 1
…a Mandibular Bone Lengthener (K945674), the Wells Johnson Fixation System (8945500), the Synthes Mim Lengthening Apparatus (K914558) and the Synthes Mandible Distractor (K962272). Each of these devices is intended for use as a mandibular bone lengthener and 1s manufactured from stainless steel. The designs…
Synthes (Usa)1996—

Also cleared against K945674: 1 other device →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc.199711
K972154Cohen DistractorHowmedica Leibinger, Inc.19978
K990944Osteomed Intraoral Distraction SystemOsteomed Corp.19997
K013618Intraoral Mandibular Distraction SystemOsteomed Corp.20026
K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial20103

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 18 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K972166 (Howmedica Leibinger, Inc., 1997) has gone furthest, with 11 descendants of its own.
  • 1 other device also cites its predicate K945674.

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?

It is intended for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.

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 K945674

1 other device cites the same predicate.

  • K960297Mandibular Bone Distractor IIHowmedica Corp. · 1996

More from Howmedica Leibinger, Inc.

11 FDA decisions under this applicant name. See the company

  • K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  • K972166Guerrero - Bell DistractorHowmedica Leibinger, Inc. · 1997
  • K972154Cohen DistractorHowmedica Leibinger, Inc. · 1997
  • K961719Epitec Titanium Implant System for the Surgical Anchoring of Facial ProsthesesHowmedica Leibinger, Inc. · 1997
  • K963030Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997

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/K964649 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964649: Vazquez Diner Intraoral Distraction Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964649

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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