510(k) · Cleared
ClearedOptimus CMF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonic Co., Ltd. · JEY Plate, Bone
Cleared on Oct 20, 2016 as substantially equivalent to K140037 (Osteonic Co., Ltd., 2015) after a 254-day review. Its family tree reaches back 7 generations to 1976.
- Decided
- Oct 20, 2016
- Review
- 254 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K761228 (1976). 38 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 6 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 5 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 4 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 3 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- 2 generations backK121589 Biomet Microfixation Facial Plating SystemBiomet Microfixation · 2012 · Recalled
- 1 generation backK140037 Optimus CMF SystemOsteonic Co., Ltd. · 2015
- This deviceK160363 Optimus CMF SystemOsteonic Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −6 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −5 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −4 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −3 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| −2 | K121589 | Biomet Microfixation Facial Plating System | Biomet Microfixation | 2012 | 1 |
| −1 | K140037 | Optimus CMF System | Osteonic Co., Ltd. | 2015 | — |
| 0 (this device) | 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 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K140037 | Optimus CMF SystemSummary page 4…TIMUS CMF SYSTEM ▪ Common Name – Dental Bone Plate & Screw System ▪ Classification Name – Bone Plate 4. Predicate Device: Primary Predicate Device: K140037-OPTIMUS CMF SYSTEM by Osteonic Co., Ltd. Reference Predicate Device: K112457-LeForte System Bone Plate & Screw by Jeil… | 2015 |
| † | K112457 | Leforte System Bone Plate & Screw | 2012 |
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 40 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 38 ancestors have a recall of any class.
- 1 other device also cites its predicate K140037.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 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/K160363 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160363: Optimus CMF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160363
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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