510(k) · Cleared

Cleared

Ortrautek Trauma System

K032520510(k) TraditionalCleared Nov 12, 200389-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 Nov 12, 2003 as substantially equivalent to K854886 (Walter Lorenz Surgical, Inc., 1986) and 5 other predicates after an 89-day review. Its family tree reaches back 4 generations to 1996.

Decided: Nov 12, 2003
Review: 89 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K954385 (1996). 16 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
3 generations backK981890 Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split PlatesSynthes (Usa) · 1998
2 generations backK993862 Modus Sagittal Split PlateThe Straumann Co. · 1999
1 generation backK022185 Universal CMF SystemStryker Instruments · 2002
This deviceK032520 Ortrautek Trauma SystemTekka · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K954385	Synthes Mandibular Modular Fixation System	Synthes (Usa)	1996	—
−3	K981890	Synthes (Usa) [Synthes] MMFS - 2.0 MM Sagittal Split Plates	Synthes (Usa)	1998	—
−2	K993862	Modus Sagittal Split Plate	The Straumann Co.	1999	—
−1	K022185	Universal CMF System	Stryker Instruments	2002	—
0 (this device)	K032520	Ortrautek Trauma System	Tekka	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	3	0
1994	1	0
1995	1	0
1996	3	0
1997	1	0
1998	1	0
2000	1	0
2002	1	0

FIG. 1 — Lineage of K032520, 1996–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K854886	Wuerzburg Titanium Mini Bone Plates & Bone Screws Summary page 1 …CLASSIFICATION NAME: Bone Plate DEVICE CLASSIFICATION: Class 11, 2 1 CFR j E 872.4760 PREDICATE DEVICE: K 8 5 4 8 8 6 : Wuerzburg Titanium Mini Bone Plate and Bone Screws. K 0 2 2 1 8 5 : Stryker Instruments - Universal CMF System. K 0 0 2 6 1 9 :…	Walter Lorenz Surgical, Inc.	1986	1
*	K022185	Universal CMF System Summary page 1 …Class 11, 2 1 CFR j E 872.4760 PREDICATE DEVICE: K 8 5 4 8 8 6 : Wuerzburg Titanium Mini Bone Plate and Bone Screws. K 0 2 2 1 8 5 : Stryker Instruments - Universal CMF System. K 0 0 2 6 1 9 : Stryker Instruments - NewGen System K 9 7 4 5 5 5 : Synthes 2.0 mm…	Stryker Instruments	2002	—
*	K002619	Newgen System Summary page 1 …E 872.4760 PREDICATE DEVICE: K 8 5 4 8 8 6 : Wuerzburg Titanium Mini Bone Plate and Bone Screws. K 0 2 2 1 8 5 : Stryker Instruments - Universal CMF System. K 0 0 2 6 1 9 : Stryker Instruments - NewGen System K 9 7 4 5 5 5 : Synthes 2.0 mm Locking Plate System (2.0 LPS) K 9 4 4 5 6 1 : KLS-Martin Mi…	Stryker Instruments	2000	—
*	K974555	Synthes 2.0 MM Locking Plate System (2.0 LPS) Summary page 1 …8 6 : Wuerzburg Titanium Mini Bone Plate and Bone Screws. K 0 2 2 1 8 5 : Stryker Instruments - Universal CMF System. K 0 0 2 6 1 9 : Stryker Instruments - NewGen System K 9 7 4 5 5 5 : Synthes 2.0 mm Locking Plate System (2.0 LPS) K 9 4 4 5 6 1 : KLS-Martin Micro Osteosynthesis System (1.0 mm) K 9 5 3 3 8 5 : L…	Synthes (Usa)	1998	—
*	K944561	Micro Osteosynthesis System (1.0) Summary page 1 …2 2 1 8 5 : Stryker Instruments - Universal CMF System. K 0 0 2 6 1 9 : Stryker Instruments - NewGen System K 9 7 4 5 5 5 : Synthes 2.0 mm Locking Plate System (2.0 LPS) K 9 4 4 5 6 1 : KLS-Martin Micro Osteosynthesis System (1.0 mm) K 9 5 3 3 8 5 : Lorenz 1.00 mm, 1.5 mm, 2.0 mm System DEVICE DESCRIPTION: The…	KLS-Martin L.P.	1994	—
*	K953385	Lorenz 1.0MM, 1.5MM, 2.0MM System Summary page 1 …6 1 9 : Stryker Instruments - NewGen System K 9 7 4 5 5 5 : Synthes 2.0 mm Locking Plate System (2.0 LPS) K 9 4 4 5 6 1 : KLS-Martin Micro Osteosynthesis System (1.0 mm) K 9 5 3 3 8 5 : Lorenz 1.00 mm, 1.5 mm, 2.0 mm System DEVICE DESCRIPTION: The ORTRAUTEK TRAUMA SYSTEM is composed of bone plates and bone scr…	Walter Lorenz Surgical, Inc.	1995	8

Also cleared against K854886: 9 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 7 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
3 of the 16 ancestors have a recall of any class.
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

2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007high 299 (2021) · low 75 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JEY

1in 2020

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	9	115	0	29
2008	7	84	3	24
2009	4	121	6	93
2010	6	199	85	215
2011	5	75	0	241
2012	10	194	0	428
2013	8	126	1	766
2014	6	223	0	616
2015	7	160	0	767
2016	1	—	0	558
2017	5	190	0	568
2018	7	255	0	608
2019	6	163	0	595
2020	6	198	1	680
2021	4	299	0	451
2022	5	135	0	344
2023	2	—	0	495
2024	5	159	0	696
2025	2	—	0	1,003
2026	3	258	0	—

What is it indicated for?

The ORTRAUTEK TRAUMA SYSTEM is a cranio-maxillofacial titanium

plate and screw system intended for osteotomy, stabilization and

rigid fixation of cranio-maxillofacial fracture and reconstruction.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032520 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032520: Ortrautek Trauma System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032520

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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