510(k) · Cleared

Cleared

Optimus CMF System

K140037510(k) TraditionalCleared Jan 20, 2015378-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 Jan 20, 2015 as substantially equivalent to K112457 (Arkin Consulting Group, 2012) and 7 other predicates after a 378-day review. Its family tree reaches back 6 generations to 1976. 2 later devices descend from it.

Decided: Jan 20, 2015
Review: 378 days
Class: Class II
Product code: JEY
Recalls: None
Predicates: 8

Its longest line of descent runs back 6 generations to K761228 (1976). 37 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 6 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
5 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
4 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
3 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
2 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
1 generation backK121589 Biomet Microfixation Facial Plating SystemBiomet Microfixation · 2012 · Recalled
This deviceK140037 Optimus CMF SystemOsteonic Co., Ltd. · 2015
Descendant · cites it directly · 0 of its ownK253373 Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
Descendant · cites it directly · 0 of its ownK160363 Optimus CMF SystemOsteonic Co., Ltd. · 2016

Most influential descendants

Showing 2 of 2 · See all

K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025 · cites it directly0descendants
K160363Optimus CMF SystemOsteonic Co., Ltd. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K761228	Luhr Mandibular Compression-Screw System	Howmedica Corp.	1976	—
−5	K963739	Leibinger - Luhr Small Orthopedic Bone Screws	Howmedica Leibinger, Inc.	1997	—
−4	K970912	Leibinger Self-Drilling Screw	Howmedica Leibinger, Inc.	1997	—
−3	K974785	Auto-Drive Bone Screw	Osteomed Corp.	1998	—
−2	K013954	Lorenz Self Drilling Screws	Walter Lorenz Surgical, Inc.	2002	—
−1	K121589	Biomet Microfixation Facial Plating System	Biomet Microfixation	2012	1
0 (this device)	K140037	Optimus CMF System	Osteonic Co., Ltd.	2015	—
+1	K253373	Southern Craniomaxillofacial (CMF) System	Southern Medical (Pty), Ltd.	2025	—
+1	K160363	Optimus CMF System	Osteonic Co., Ltd.	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1986	3	0
1988	1	0
1991	2	0
1992	1	0
1994	2	0
1995	1	0
1996	5	0
1997	4	0
1998	2	0
2002	1	0
2004	2	0
2007	1	0
2009	2	0
2011	1	0
2012	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2025	1	0

FIG. 1 — Lineage of K140037, 1976–2025Source: 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? (8)

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
*	K112457	Leforte System Bone Plate & Screw Summary page 4 …e Plate Screw, fixation, intraosseous 4. Predicate Device: ▪ LeForte System Bone Plate & Screw by Jeil Medical Corporation (K112457) ▪ Synthes Matrix Mandibule Plate and Screw System by Synthes Inc. ( K113567) ▪ Biomet Microfixation Facial Plati…	Arkin Consulting Group	2012	—
*	K113567	Synthes Matrixmadible Plate and Screw System Summary page 4 …ate Device: ▪ LeForte System Bone Plate & Screw by Jeil Medical Corporation (K112457) ▪ Synthes Matrix Mandibule Plate and Screw System by Synthes Inc. ( K113567) ▪ Biomet Microfixation Facial Plating System by Biomet Microfixation (K121589) ▪ Synthes (USA) Midfacial System…	Synthes, Inc.	2012	—
*	K121589	Biomet Microfixation Facial Plating System Summary page 4 …12457) ▪ Synthes Matrix Mandibule Plate and Screw System by Synthes Inc. ( K113567) ▪ Biomet Microfixation Facial Plating System by Biomet Microfixation (K121589) ▪ Synthes (USA) Midfacial System by Synthes (USA) (K953806) ▪ Synthes 1.3mm Self-Drilling Screw by Synthes (USA)…	Biomet Microfixation	2012	1
*	K953806	Synthes (Usa) Midfacial System Summary page 4 …Synthes Inc. ( K113567) ▪ Biomet Microfixation Facial Plating System by Biomet Microfixation (K121589) ▪ Synthes (USA) Midfacial System by Synthes (USA) (K953806) ▪ Synthes 1.3mm Self-Drilling Screw by Synthes (USA) (K983485) ▪ Leibinger IMF Screw by Howmedical Leibinger, In…	Synthes (Usa)	1996	—
*	K983485	Synthes 1.3 MM Self-Drilling Screw Summary page 4 …ystem by Biomet Microfixation (K121589) ▪ Synthes (USA) Midfacial System by Synthes (USA) (K953806) ▪ Synthes 1.3mm Self-Drilling Screw by Synthes (USA) (K983485) ▪ Leibinger IMF Screw by Howmedical Leibinger, Inc. (K963030) ▪ Synthes (USA) Craniofacial Plates by Synthes (US…	Synthes (Usa)	1998	—
*	K963030	Leibinger Imf Screw Summary page 4 …ial System by Synthes (USA) (K953806) ▪ Synthes 1.3mm Self-Drilling Screw by Synthes (USA) (K983485) ▪ Leibinger IMF Screw by Howmedical Leibinger, Inc. (K963030) ▪ Synthes (USA) Craniofacial Plates by Synthes (USA) (K040272) ▪ Leforte System Bone Plate by Jeil Medical Copor…	Howmedica Leibinger, Inc.	1997	—
*	K040272	Synthes (Usa) Craniofacial Plates Summary page 4 …ling Screw by Synthes (USA) (K983485) ▪ Leibinger IMF Screw by Howmedical Leibinger, Inc. (K963030) ▪ Synthes (USA) Craniofacial Plates by Synthes (USA) (K040272) ▪ Leforte System Bone Plate by Jeil Medical Coporation (K091679) 5. Product Code & Regulation Number: ▪ JE…	Synthes (Usa)	2004	—
*	K091679	Leforte System Bone Plate Summary page 4 …wmedical Leibinger, Inc. (K963030) ▪ Synthes (USA) Craniofacial Plates by Synthes (USA) (K040272) ▪ Leforte System Bone Plate by Jeil Medical Coporation (K091679) 5. Product Code & Regulation Number: ▪ JEY (21CFR872.4760) ▪ DZL (21CFR872.4880) 6. Description:…	Jeil Medical Corporation	2009	—

Also cleared against K112457: 4 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
K253373	Southern Craniomaxillofacial (CMF) System	Southern Medical (Pty), Ltd.	2025	0
K160363	Optimus CMF System	Osteonic Co., Ltd.	2016	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 39 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
4 of the 37 ancestors have a recall of any class.
Of its descendants, K253373 (Southern Medical (Pty), Ltd., 2025) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K112457.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?

Optimus CMF System is implantable bone plates and bone screws for maxillofacial and

mandible surgery procedures including:

1. Fractures

2. Osteotomies

3. Reconstructive procedures

4. Revision procedures where other treatments or devices have failed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140037 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140037: Optimus CMF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140037

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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