510(k) · Cleared

Cleared

Osteomed Modular Locking Fixation System

K080694510(k) TraditionalCleared May 15, 200865-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

Cleared on May 15, 2008 as substantially equivalent to K063790 (Synthes (Usa), 2007) and 6 other predicates after a 65-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.

Decided: May 15, 2008
Review: 65 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 7

Its longest line of descent runs back 4 generations to K954385 (1996). 25 ancestors in all, the oldest K854886 (1986). 2 later devices descend from it, 2 citing it directly.

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 deviceK080694 Osteomed Modular Locking Fixation SystemOsteomed LP · 2008
Descendant · cites it directly · 0 of its ownK182609 Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019
Descendant · cites it directly · 0 of its ownK143338 Argulated Locking PlatesOsteomed LP · 2015

Most influential descendants

Showing 2 of 2 · See all

K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019 · cites it directly0descendants
K143338Argulated Locking PlatesOsteomed LP · 2015 · cites it directly0descendants

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)	K080694	Osteomed Modular Locking Fixation System	Osteomed LP	2008	—
+1	K182609	Delphos Implants Rigid Fixation System	Delphos Implants - Ind.Com. Importacao E Exportacao DE	2019	—
+1	K143338	Argulated Locking Plates	Osteomed LP	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	3	0
1991	1	0
1993	1	0
1994	1	0
1995	1	0
1996	3	0
1997	1	0
1998	2	0
2000	2	0
2001	1	0
2002	1	0
2003	2	0
2007	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2019	1	0

FIG. 1 — Lineage of K080694, 1996–2019Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K063790	The Synthes Matrixmandible Plate and Screw System Summary page 1 …ates will also be a part of the system. Equivalence for this device is based on similarities in -intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448 ), and Lorenz (K063052). OsteoMed also notes, that…	Synthes (Usa)	2007	—
*	K022185	Universal CMF System Summary page 1 …a part of the system. Equivalence for this device is based on similarities in -intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448 ), and Lorenz (K063052). OsteoMed also notes, that some sections of…	Stryker Instruments	2002	—
*	K032442	KLS-Martin Mandibular/Reconstruction System II Summary page 1 …e system. Equivalence for this device is based on similarities in -intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448 ), and Lorenz (K063052). OsteoMed also notes, that some sections of this system c…	KLS-Martin L.P.	2003	—
*	K911936	Osteomed SBF System (SBF) Summary page 1 …nce for this device is based on similarities in -intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448 ), and Lorenz (K063052). OsteoMed also notes, that some sections of this system could have been lett…	Osteomed Corp.	1991	—
*	K924138	Osteomed M3 System (SBF System) Summary page 1 …ce is based on similarities in -intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448 ), and Lorenz (K063052). OsteoMed also notes, that some sections of this system could have been letter to file based…	Osteomed Corp.	1993	—
*	K030448	Osteomed 2.0 Locking Plates and Screws Summary page 1 …on similarities in -intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448 ), and Lorenz (K063052). OsteoMed also notes, that some sections of this system could have been letter to file based on the Osteo…	Osteomed LP	2003	—
*	K063052	Lorenz Titanium Fracture / Reconstruction Devices and Pre-Bent Plates Summary page 1 …ended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448 ), and Lorenz (K063052). OsteoMed also notes, that some sections of this system could have been letter to file based on the OsteoMed previously cleared…	Walter Lorenz Surgical, Inc.	2007	—

Also cleared against K063790: 6 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K182609	Delphos Implants Rigid Fixation System	Delphos Implants - Ind.Com. Importacao E Exportacao DE	2019	0
K143338	Argulated Locking Plates	Osteomed LP	2015	0

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 12 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
2 of the 25 ancestors have a recall of any class.
Of its descendants, K182609 (Delphos Implants - Ind.Com. Importacao E Exportacao DE, 2019) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K063790.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.

The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only,

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080694 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080694: Osteomed Modular Locking Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080694

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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