510(k) · Cleared
ClearedRapidsorb Plus Screw System
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 Jan 25, 2010 as substantially equivalent to K062789 (Synthes (Usa), 2007) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jan 25, 2010
- Review
- 80 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981666 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK981666 2.5 MM Lactosorb ScrewsBiomet, Inc. · 1998
- This deviceK093464 Rapidsorb Plus Screw SystemSynthes (Usa) · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981666 | 2.5 MM Lactosorb Screws | Biomet, Inc. | 1998 | — |
| 0 (this device) | K093464 | Rapidsorb Plus Screw System | Synthes (Usa) | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (2)
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 |
|---|---|---|---|
| * | K062789 | Synthes (Usa) Rapid Resorbable Fixation SystemSummary page 1…fication: Class II, 21 CFR §872.4880 - Screw, Fixation, Intraosseous Product Code DZL Predicate Device: Synthes Rapid Resorbable Fixation System (K062789) Biomet LactoSorbO Screws (K98 1666) Device Synthes' RapidSorb PLUS Screw System cons… | 2007 |
| * | K981666 | 2.5 MM Lactosorb ScrewsSummary page 1…Intraosseous Product Code DZL Predicate Device: Synthes Rapid Resorbable Fixation System (K062789) Biomet LactoSorbO Screws (K98 1666) Device Synthes' RapidSorb PLUS Screw System consists of Description: resorbable screws and relate… | 1998 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 6 other devices also cite its predicate K062789.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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' RapidSorb PLUS screws are indicated for use as fixation in mandibular osteotomy procedures, including:
* sagital split osteotomy
* vertical ramus osteotomy
*inferior border osteotomy
*subapical. osteotomy
*genioplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093464: Rapidsorb Plus Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093464
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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