510(k) Report

510(k) · Cleared

Cleared

Ortrautek Orthognathic System

K031989510(k) TraditionalCleared Oct 28, 2003123-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

Tekka · JEY Plate, Bone

Cleared on Oct 28, 2003 as substantially equivalent to K854886 (Walter Lorenz Surgical, Inc., 1986) and 6 other predicates after a 123-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it.

Decided
Oct 28, 2003
Review
123 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K953806 (1996). 12 ancestors in all, the oldest K854886 (1986). 5 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors1986: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors2010: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant clearedK953806 · Synthes (Usa) Midfacial System · Synthes (Usa) · 1996K980199 · Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws · Synthes (Usa) · 1998K021618 · Osa Rigid Internal Fixation System · Osteomed Corp. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants K021618 · Osa Rigid Internal Fixation System · Osteomed Corp. · 2002K980199 · Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws · Synthes (Usa) · 1998K953806 · Synthes (Usa) Midfacial System · Synthes (Usa) · 19960
  1. Root · 3 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
  2. 2 generations backK980199 Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and ScrewsSynthes (Usa) · 1998
  3. 1 generation backK021618 Osa Rigid Internal Fixation SystemOsteomed Corp. · 2002
  4. This deviceK031989 Ortrautek Orthognathic SystemTekka · 2003
  5. Descendant · cites it directly · 4 of its ownK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
  6. Descendant · 2 generations on · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
  7. Descendant · 3 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
  8. Descendant · 4 generations on · 0 of its ownK222367 Save GBRDentis Co., Ltd. · 2023
  9. Descendant · 4 generations on · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020

Most influential descendants

Showing 5 of 5 · See all
  • K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc. · 2010 · cites it directly4descendants
  • K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · 2 generations on3descendants
  • K170697GBR systemSurgident · 2018 · 3 generations on2descendants
  • K222367Save GBRDentis Co., Ltd. · 2023 · 4 generations on0descendants
  • K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K953806Synthes (Usa) Midfacial SystemSynthes (Usa)1996—
−2K980199Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and ScrewsSynthes (Usa)1998—
−1K021618Osa Rigid Internal Fixation SystemOsteomed Corp.2002—
0 (this device)K031989Ortrautek Orthognathic SystemTekka2003—
+1K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.2010—
+2K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.2014—
+3K170697GBR systemSurgident2018—
+4K222367Save GBRDentis Co., Ltd.2023—
+4K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199420
199510
199620
199710
199810
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201410
201810
202010
202310
FIG. 1 — Lineage of K031989, 1996–2023Source: 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? (7)

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
*K854886Wuerzburg Titanium Mini Bone Plates & Bone Screws
Summary page 1
…STEM COMMON OR USUAL NAME: Bone Plate System CLASSIFICATION NAME: Bone Plate DEVICE CLASSIFICATION: Class 11, 21 CFR 5 872.4760 r PREDICATE DEVICE: K854886: Wuerzburg Titanium Mini Bone Plate and Bone Screws. K 9 7 4 5 5 5 : Synthes 2.0 MM Locking Plate System (2.0 LPS) K 0 2 1 6 1 8…
Walter Lorenz Surgical, Inc.19861
*K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)
Summary page 1
…AME: Bone Plate DEVICE CLASSIFICATION: Class 11, 21 CFR 5 872.4760 r PREDICATE DEVICE: K854886: Wuerzburg Titanium Mini Bone Plate and Bone Screws. K 9 7 4 5 5 5 : Synthes 2.0 MM Locking Plate System (2.0 LPS) K 0 2 1 6 1 8 : OSA Rigid Internal Fixation System K 9 4 4 5 6 1 : KLS-Martin Mic…
Synthes (Usa)1998—
*K021618Osa Rigid Internal Fixation System
Summary page 1
…2.4760 r PREDICATE DEVICE: K854886: Wuerzburg Titanium Mini Bone Plate and Bone Screws. K 9 7 4 5 5 5 : Synthes 2.0 MM Locking Plate System (2.0 LPS) K 0 2 1 6 1 8 : OSA Rigid Internal Fixation System K 9 4 4 5 6 1 : KLS-Martin Micro Osteosynthesis System (1.Omm) K 9 4 4 5 6 5 : KLS-Martin Mi…
Osteomed Corp.2002—
*K944561Micro Osteosynthesis System (1.0)
Summary page 1
…886: Wuerzburg Titanium Mini Bone Plate and Bone Screws. K 9 7 4 5 5 5 : Synthes 2.0 MM Locking Plate System (2.0 LPS) K 0 2 1 6 1 8 : OSA Rigid Internal Fixation System K 9 4 4 5 6 1 : KLS-Martin Micro Osteosynthesis System (1.Omm) K 9 4 4 5 6 5 : KLS-Martin Micro Osteosynthesis System (1.5mm) K 9 5 3 3 8 5 : L…
KLS-Martin L.P.1994—
*K944565KLS-Martin Micro Osteosythesis System (1.5MM)
Summary page 1
…4 5 5 5 : Synthes 2.0 MM Locking Plate System (2.0 LPS) K 0 2 1 6 1 8 : OSA Rigid Internal Fixation System K 9 4 4 5 6 1 : KLS-Martin Micro Osteosynthesis System (1.Omm) K 9 4 4 5 6 5 : KLS-Martin Micro Osteosynthesis System (1.5mm) K 9 5 3 3 8 5 : Lorenz l.OOMM, l.SMM, 2.OMM System K 0 1 2 9 1 0 : The Bioplate…
KLS-Martin L.P.1994—
*K953385Lorenz 1.0MM, 1.5MM, 2.0MM System
Summary page 1
…6 1 8 : OSA Rigid Internal Fixation System K 9 4 4 5 6 1 : KLS-Martin Micro Osteosynthesis System (1.Omm) K 9 4 4 5 6 5 : KLS-Martin Micro Osteosynthesis System (1.5mm) K 9 5 3 3 8 5 : Lorenz l.OOMM, l.SMM, 2.OMM System K 0 1 2 9 1 0 : The Bioplate Mandible Fixation System DEVICE DESCRIPTION: The ORTRAUTEK ORT…
Walter Lorenz Surgical, Inc.19958
*K012910The Bioplate Mandible Fixation System
Our reading of the summary gave K012901, FDA’s number for Color-Monogen (Instrumentation Laboratory CO). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “The Bioplate Mandible Fixation System”.
Bioplate, Inc.2001—

Also cleared against K854886: 9 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104

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 7 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • Of its descendants, K091812 (Frontier Devices, Inc., 2010) has gone furthest, with 4 descendants of its own.
  • 9 other devices also cite its predicate K854886.

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 ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.

Indications for use as stated in the FDA summary.

Also cleared against K854886

9 other devices cite the same predicate.

  • K121624Biomet Microfixation Neuro Plating SystemBiomet Microfixation · 20122 recalls
  • K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation · 20121 recall
  • K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2006
  • K032520Ortrautek Trauma SystemTekka · 2003
  • K022185Universal CMF SystemStryker Instruments · 2002
  • K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc. · 2002

More from Tekka

2 FDA decisions under this applicant name. See the company

  • K032520Ortrautek Trauma SystemTekka · 2003

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/K031989 · printed Nov 4, 2026

Cite this page

510(k) Report. “K031989: Ortrautek Orthognathic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031989

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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