510(k) · Cleared
ClearedOsteomedics Resorbable Small Fixation System, Osteosorb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomedics, Inc. · JEY Plate, Bone
Cleared on Jan 17, 2003 after a 210-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 17, 2003
- Review
- 210 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK022035 Osteomedics Resorbable Small Fixation System, OsteosorbOsteomedics, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK030989 Osteosorb Tack Fixation SystemNoviace Corporation · 2004
Most influential descendants
Showing 1 of 1 · See all- K030989Osteosorb Tack Fixation SystemNoviace Corporation · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022035 | Osteomedics Resorbable Small Fixation System, Osteosorb | Osteomedics, Inc. | 2003 | — |
| +1 | K030989 | Osteosorb Tack Fixation System | Noviace Corporation | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | — | Bionx BiosorbFx 1Y2.0 Bioabsorbable Fixation System Named without a submission number | |
| * | — | BiosorbFx 2.0/2.4 Orthognathic / Mandibular Fix Named without a submission number | |
| * | — | Stryker Leibinger Wurzburg Titanium Mini Bone Plates and Bone Screws Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030989 | Osteosorb Tack Fixation System | 2004 | 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?
- Of its descendants, K030989 (Noviace Corporation, 2004) has gone furthest, with 0 descendants of its own.
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?
The OsteomedicsB Resorbable Small Fixation System is intended for use in selective trauma or for reconstructive procedures in the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures, and selective orthognathic surgery of the maxilla and chin. The OsteomedicsB Resorbable Small Fixation System stabilizes bone during healing in conjunction with appropriate postoperative immobilization. The use is in both adult and pediatric patients' cases involving trauma or reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022035: Osteomedics Resorbable Small Fixation System, Osteosorb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022035
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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