510(k) · Cleared
ClearedOsteomed 2.0 Locking Plates and Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · JEY Plate, Bone
Cleared on May 9, 2003 as substantially equivalent to K974555 (Synthes (Usa), 1998) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1996. 444 later devices descend from it.
- Decided
- May 9, 2003
- Review
- 87 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K954385 (1996). 7 ancestors in all. 444 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 1 generation backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- This deviceK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- Descendant · cites it directly · 435 of its ownK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- Descendant · 2 generations on · 360 of its ownK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- Descendant · 3 generations on · 343 of its ownK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- Descendant · 4 generations on · 342 of its ownK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- Descendant · 5 generations on · 339 of its ownK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
Showing 5 of 444 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 444 · See all- K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003 · cites it directly435descendants
- K040598KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004 · 2 generations on360descendants
- K050868MaxlockOrthohelix Surgical Designs, Inc. · 2005 · 3 generations on343descendants
- K073624Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · 4 generations on342descendants
- K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc. · 2010 · 5 generations on339descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −1 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| 0 (this device) | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| +1 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| +2 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| +3 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| +4 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| +5 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 16 | 0 |
| 2013 | 10 | 0 |
| 2014 | 20 | 0 |
| 2015 | 27 | 0 |
| 2016 | 17 | 0 |
| 2017 | 32 | 0 |
| 2018 | 17 | 0 |
| 2019 | 21 | 0 |
| 2020 | 28 | 0 |
| 2021 | 28 | 0 |
| 2022 | 29 | 0 |
| 2023 | 38 | 0 |
| 2024 | 54 | 0 |
| 2025 | 39 | 0 |
| 2026 | 51 | 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? (3)
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 |
|---|---|---|---|
| * | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS)Summary page 1…is device is based on similarities in intended use, materia[, design and operational principle to the Synthes 2.0 Locking Plate System (K9745551, the Stryker Leiblnger Locking Screw Mandibular Reconstruction Plate(K000594). and the Stryker Leiblnger Newgen… | 1998 |
| * | K000594 | Locking Screw Mandibular Reconstruction PlateSummary page 1…tional principle to the Synthes 2.0 Locking Plate System (K9745551, the Stryker Leiblnger Locking Screw Mandibular Reconstruction Plate(K000594). and the Stryker Leiblnger Newgen/Universal Mandibular System(KO14263). Due to the similarity… | 2000 |
| * | K014263 | Newgen/Universal Mandibular System | 2002 |
What descends from it? (444)
See all 4444 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K032442 (KLS-Martin L.P., 2003) has gone furthest, with 435 descendants of its own.
- 6 other devices also cite its predicate K974555.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Indicated for oral, maxillofacial surgery; trauma; reconstructive surgery; and orthognathic surgery (surgical correction of dentofacial deformities). 2.0 Locking plates and screws are intended for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030448: Osteomed 2.0 Locking Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030448
Report an extraction error
Are you the manufacturer?
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