510(k) Report

510(k) · Cleared

Cleared

Leibinger Advance Internal Midface Distraction System

K121235510(k) TraditionalCleared Jan 9, 2014625-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

Stryker · JEY Plate, Bone

Cleared on Jan 9, 2014 as substantially equivalent to K972154 (Howmedica Leibinger, Inc., 1997) and 3 other predicates after a 625-day review. Its family tree reaches back 5 generations to 1979.

Decided
Jan 9, 2014
Review
625 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K792561 (1979). 14 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 1 other ancestor1996: 2 other ancestors1995: 3 other ancestors1992: 1 other ancestor1986: 1 other ancestorK792561 · Mini-H-Fixation · Geny Medical, Inc. · 1979×2: 2 generations cleared close together, K962272 (1996), K964649 (1997) K972154 · Cohen Distractor · Howmedica Leibinger, Inc. · 1997K092743 · The Leibinger Advance Internal Midface Distraction System · Stryker Craniomaxillofacial · 20101980199020002010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 4 other ancestors K092743 · The Leibinger Advance Internal Midface Distraction System · Stryker Craniomaxillofacial · 2010K972154 · 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. · 1979−50
  1. Root · 5 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
  2. 4 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
  3. 3 generations backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
  4. 2 generations backK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
  5. 1 generation backK092743 The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial · 2010
  6. This deviceK121235 Leibinger Advance Internal Midface Distraction SystemStryker · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K792561Mini-H-FixationGeny Medical, Inc.1979—
−4K962272Synthes Mandible DistractorSynthes (Usa)1996—
−3K964649Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc.1997—
−2K972154Cohen DistractorHowmedica Leibinger, Inc.1997—
−1K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial2010—
0 (this device)K121235Leibinger Advance Internal Midface Distraction SystemStryker2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199210
199530
199620
200110
200210
FIG. 1 — Lineage of K121235, 1979–2014Source: 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
…Jamshed.badarpura~stryker.com Date Prepared: April 23, 2012 Predicate Devices: Cohen Distractor (K972154), Synthes Midface Distractor (K022005), Molina Orbital…
Howmedica Leibinger, Inc.1997—
*K022005Synthes Midface Distractor
Summary page 1
…d: April 23, 2012 Predicate Devices: Cohen Distractor (K972154), Synthes Midface Distractor (K022005), Molina Orbital Malar Distractor (K003883), Leibinger…
Synthes (Usa)2002—
*K003883Molina Orbital Malar Distractor
Summary page 1
…en Distractor (K972154), Synthes Midface Distractor (K022005), Molina Orbital Malar Distractor (K003883), Leibinger Advance Internal Midface Distraction System…
KLS-Martin L.P.2001—
*K092743The Leibinger Advance Internal Midface Distraction System
Summary page 1
…lina Orbital Malar Distractor (K003883), Leibinger Advance Internal Midface Distraction System (K092743). Description: The Leibinger Advance Internal Midface Distraction System is a distraction system consisting of the following m…
Stryker Craniomaxillofacial2010—

Also cleared against K972154: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 35 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
  • None of the 14 ancestors has a recall.
  • 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. 2014, 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 Leibinger Advance Internal Midface Distraction System is indicated for the treatment of syndromic and non-syndromic craniosynostosis, midface retrusion, congenital midfacial hypoplasia, and craniofacial dysostosis in patients two years of age and older.

Indications for use as stated in the FDA summary.

Also cleared against K972154

4 other devices cite the same predicate.

  • 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
  • K973484Chin DistractorHowmedica, Inc. · 1997

More from Stryker

92 FDA decisions under this applicant name. See the company

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  • K2306051788 4K Camera System with Advanced Imaging ModalityStryker · 2023
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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/K121235 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121235: Leibinger Advance Internal Midface Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121235

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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