510(k) Report

510(k) · Cleared

Cleared

Chin Distractor

K973484510(k) TraditionalCleared Dec 2, 199778-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, Inc. · JEY Plate, Bone

Cleared on Dec 2, 1997 as substantially equivalent to K972154 (Howmedica Leibinger, Inc., 1997) and 3 other predicates after a 78-day review. Its family tree reaches back 4 generations to 1979. 1 later device descends from it.

Decided
Dec 2, 1997
Review
78 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K792561 (1979). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 4 other ancestors1990: 1 other ancestor1987: 1 other ancestor1996: 2 other ancestors1992: 1 other ancestor1986: 1 other ancestor2003: 1 descendant clearedK792561 · Mini-H-Fixation · Geny Medical, Inc. · 1979×2: 2 generations cleared close together, K962272 (1996), K964649 (1997) K972154 · Cohen Distractor · Howmedica Leibinger, Inc. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 4 other ancestors 1 generation forward: 1 descendant K972154 · Cohen Distractor · Howmedica Leibinger, Inc. · 1997K964649 · Vazquez Diner Intraoral Distraction Device · Howmedica Leibinger, Inc. · 1997K962272 · Synthes Mandible Distractor · Synthes (Usa) · 1996K792561 · Mini-H-Fixation · Geny Medical, Inc. · 19790
  1. Root · 4 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
  2. 3 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
  3. 2 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
  4. 1 generation backK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
  5. This deviceK973484 Chin DistractorHowmedica, Inc. · 1997
  6. Descendant · cites it directly · 0 of its ownK030790 Osteomed Alveolar Distraction SystemOsteomed LP · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K030790Osteomed Alveolar Distraction SystemOsteomed LP · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K792561Mini-H-FixationGeny Medical, Inc.1979—
−3K962272Synthes Mandible DistractorSynthes (Usa)1996—
−2K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc.1997—
−1K972154Cohen DistractorHowmedica Leibinger, Inc.1997—
0 (this device)K973484Chin DistractorHowmedica, Inc.1997—
+1K030790Osteomed Alveolar Distraction SystemOsteomed LP2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
199010
199210
199540
199620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K973484, 1979–2003Source: 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
*K972154Cohen Distractor
Summary page 1
…rom titanium. The Chin Distractor is substantially equivalent to several other legally marketed devices. Examples of these are: 1. Cohen Distractor Howmedica Leibinger K972154 2. Luhr® Micro Mesh Howmedica K901940 3. Titanium Osteosynthesis System W. Lorenz Surgical K953385 4. Soft Tissue Expander (V…
Howmedica Leibinger, Inc.1997—
*K901940Luhr Micro Mesh
Summary page 1
…ubstantially equivalent to several other legally marketed devices. Examples of these are: 1. Cohen Distractor Howmedica Leibinger K972154 2. Luhr® Micro Mesh Howmedica K901940 3. Titanium Osteosynthesis System W. Lorenz Surgical K953385 4. Soft Tissue Expander (Versafil STE) Cox-Uphuff Int. K874276 Fo…
Howmedica Corp.1990—
*K953385Lorenz 1.0MM, 1.5MM, 2.0MM System
Summary page 1
…es. Examples of these are: 1. Cohen Distractor Howmedica Leibinger K972154 2. Luhr® Micro Mesh Howmedica K901940 3. Titanium Osteosynthesis System W. Lorenz Surgical K953385 4. Soft Tissue Expander (Versafil STE) Cox-Uphuff Int. K874276 For information contact: John Dichiara Group Regulatory Affairs…
Walter Lorenz Surgical, Inc.19958
*K874276Cui, Versafil (TM), Ste (TM) Tissue Expander
Summary page 1
…ger K972154 2. Luhr® Micro Mesh Howmedica K901940 3. Titanium Osteosynthesis System W. Lorenz Surgical K953385 4. Soft Tissue Expander (Versafil STE) Cox-Uphuff Int. K874276 For information contact: John Dichiara Group Regulatory Affairs Manager Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07…
Cox-Uphuff Intl.1987—

Also cleared against K972154: 4 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
K030790Osteomed Alveolar Distraction SystemOsteomed LP20030

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 4 companies; a new generation was cleared every 7 months on median.
  • 1 of the 14 ancestors has a recall of any class.
  • Of its descendants, K030790 (Osteomed LP, 2003) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K972154.

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?

This device is intended for use in patients requiring alveolar ridge augmentation of the mandible or maxilla secondary. This includes conditions secondary to trauma, periodontal disease or birth abnormality. The device is intended to provide temporary stabilization and gradual expansion of the alveolar ridge.

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 K972154

4 other devices cite the same predicate.

  • K121235Leibinger Advance Internal Midface Distraction SystemStryker · 2014
  • K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial · 2010
  • K031708Osteomed Maxillary/Lefort Iii Distraction SystemOsteomed LP · 2003
  • K982604Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc. · 1998

More from Howmedica, Inc.

36 FDA decisions under this applicant name. See the company

  • K984251Xia Spine SystemHowmedica, Inc. · 1999
  • K984202Howmedica Humeral Intercalary SystemHowmedica, Inc. · 1999
  • K984305Zeta Multizone Locking Nail SystemHowmedica, Inc. · 1999
  • K983885Burr Hole Covers, Craniomaxillofacial PlatesHowmedica, Inc. · 1999
  • K983358G/K SFN and STN Locking NailsHowmedica, Inc. · 1998

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/K973484 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973484: Chin Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973484

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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