510(k) · Cleared
ClearedSynthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · DZL Screw, Fixation, Intraosseous
Cleared on Apr 17, 1998 as substantially equivalent to K953806 (Synthes (Usa), 1996) after an 87-day review. Its family tree reaches back 1 generation to 1996. 10 later devices descend from it.
- Decided
- Apr 17, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953806 (1996). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK953806 Synthes (Usa) Midfacial SystemSynthes (Usa) · 1996
- This deviceK980199 Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and ScrewsSynthes (Usa) · 1998
- Descendant · cites it directly · 6 of its ownK021618 Osa Rigid Internal Fixation SystemOsteomed Corp. · 2002
- Descendant · 2 generations on · 5 of its ownK031989 Ortrautek Orthognathic SystemTekka · 2003
- Descendant · 3 generations on · 4 of its ownK091812 Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic…Frontier Devices, Inc. · 2010
- Descendant · 4 generations on · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · 5 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K021618Osa Rigid Internal Fixation SystemOsteomed Corp. · 2002 · cites it directly6descendants
- K031989Ortrautek Orthognathic SystemTekka · 2003 · 2 generations on5descendants
- K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc. · 2010 · 3 generations on4descendants
- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · 4 generations on3descendants
- K170697GBR systemSurgident · 2018 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953806 | Synthes (Usa) Midfacial System | Synthes (Usa) | 1996 | — |
| 0 (this device) | K980199 | Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws | Synthes (Usa) | 1998 | — |
| +1 | K021618 | Osa Rigid Internal Fixation System | Osteomed Corp. | 2002 | — |
| +2 | K031989 | Ortrautek Orthognathic System | Tekka | 2003 | — |
| +3 | K091812 | Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible… | Frontier Devices, Inc. | 2010 | — |
| +4 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +5 | K170697 | GBR system | Surgident | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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 DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 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 |
|---|---|---|---|
| * | K953806 | Synthes (Usa) Midfacial SystemSummary page 1…t: Sheri L. Musgnung Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Plate, Bone Class IT, 21 CFR 888.3030 and 872.4760 Synthes Midfacial System (K953806) Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L-, and Z- plate configurations, and attach… | 1996 |
What descends from it? (10)
3 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?
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, they are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
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/K980199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980199: Synthes 1.5MM/2.0MM Orthognathic Maxillary Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980199
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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