510(k) · Cleared
ClearedOsa Rigid Internal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · JEY Plate, Bone
Cleared on Aug 8, 2002 as substantially equivalent to K980199 (Synthes (Usa), 1998) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.
- Decided
- Aug 8, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K953806 (1996). 3 ancestors in all, the oldest K944565 (1994). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- 1 generation backK980199 Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and ScrewsSynthes (Usa) · 1998
- This deviceK021618 Osa Rigid Internal Fixation SystemOsteomed Corp. · 2002
- Descendant · cites it directly · 5 of its ownK031989 Ortrautek Orthognathic SystemTekka · 2003
- Descendant · 2 generations on · 4 of its ownK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
- Descendant · 3 generations on · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · 4 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
- Descendant · 5 generations on · 0 of its ownK222367 Save GBRDentis Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031989Ortrautek Orthognathic SystemTekka · 2003 · cites it directly5descendants
- K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc. · 2010 · 2 generations on4descendants
- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · 3 generations on3descendants
- K170697GBR systemSurgident · 2018 · 4 generations on2descendants
- K222367Save GBRDentis Co., Ltd. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| −1 | K980199 | Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws | Synthes (Usa) | 1998 | — |
| 0 (this device) | K021618 | Osa Rigid Internal Fixation System | Osteomed Corp. | 2002 | — |
| +1 | K031989 | Ortrautek Orthognathic System | Tekka | 2003 | — |
| +2 | K091812 | Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible… | Frontier Devices, Inc. | 2010 | — |
| +3 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +4 | K170697 | GBR system | Surgident | 2018 | — |
| +5 | K222367 | Save GBR | Dentis Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K980199 | Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and ScrewsSummary page 1…similarities in intended use, material, design and operational principle to the Synthes 1.5mm/2.0mm Orthognathic Plates and Screws system (K980199), the KLS Martin Lindorf System (K944565), and the Leibinger Profil-0-Plastic, Titanium Implant System.… | 1998 |
| * | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM)Summary page 1…design and operational principle to the Synthes 1.5mm/2.0mm Orthognathic Plates and Screws system (K980199), the KLS Martin Lindorf System (K944565), and the Leibinger Profil-0-Plastic, Titanium Implant System. Due to the similarity of materials and design to b… | 1994 |
| * | — | Leibinger Profil-0-Plastic, Titanium Implant System Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031989 | Ortrautek Orthognathic System | 2003 | 5 |
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?
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?
OsteoMed OSA Rigid Internal Fixation System is intended for a variety of pan facial indications. Specifically, the system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible. Implants are single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021618 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021618: Osa Rigid Internal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021618
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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