510(k) · Cleared
ClearedDelphos Implants Rigid Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delphos Implants - Ind.Com. Importacao E Exportacao DE · JEY Plate, Bone
Cleared on Mar 29, 2019 as substantially equivalent to K080694 (Osteomed LP, 2008) and 4 other predicates after a 189-day review. Its family tree reaches back 6 generations to 1976.
- Decided
- Mar 29, 2019
- Review
- 189 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K761228 (1976). 60 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK182609 Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019
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) | K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 4 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K080694 | Osteomed Modular Locking Fixation SystemSummary page 4…ication Regulations 21 CFR 872.4760, Class II Product Code JEY PREDICATE DEVICE INFORMATION Primary Predicate Device K080694 - Osteomed Modular Locking Fixation System - Osteomed L.P. Reference Devices K11… | 2008 |
| * | K112457 | Leforte System Bone Plate & ScrewSummary page 4…N Primary Predicate Device K080694 - Osteomed Modular Locking Fixation System - Osteomed L.P. Reference Devices K112457 - LeForte System Bone Plate & Screw - Jeil Medical Corporation… | 2012 |
| * | K121589 | Biomet Microfixation Facial Plating SystemSummary page 4…Reference Devices K112457 - LeForte System Bone Plate & Screw - Jeil Medical Corporation K121589 - Biomet Microfixation Facial Plating System - Biomet Microfixation… | 2012 |
| * | K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare Cleared while this submission was under review Summary page 4…t Microfixation K150965 – LeForte System II - Jeil Medical Corporation K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare - Visionare LLC De… | 2018 |
| * | K150965 | LeForte System IISummary page 4…K121589 - Biomet Microfixation Facial Plating System - Biomet Microfixation K150965 – LeForte System II - Jeil Medical Corporation K180204 - CranioMaxillofacial Fixation (CMF) Syst… | 2015 |
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 43 years and passes through 6 companies; a new generation was cleared every 6.5 years on median.
- 9 of the 60 ancestors have a recall of any class.
- 1 other device also cites its predicate K080694.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The Delphos Implants Rigid Fixation System implants are intended for single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182609: Delphos Implants Rigid Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182609
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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