510(k) · Cleared
ClearedBioplate Resorbable Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioplate, Inc. · DZL Screw, Fixation, Intraosseous
Cleared on Nov 28, 2001 after a 90-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Nov 28, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK012908 Bioplate Resorbable Bone ScrewBioplate, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK051845 The Bioplate Resorbable Endobrow Fixation SystemBioplate, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK061507 Sonicweld RX Endobrow FixationKLS-Martin L.P. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012908 | Bioplate Resorbable Bone Screw | Bioplate, Inc. | 2001 | — |
| +1 | K051845 | The Bioplate Resorbable Endobrow Fixation System | Bioplate, Inc. | 2005 | 1 |
| +2 | K061507 | Sonicweld RX Endobrow Fixation | KLS-Martin L.P. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | — | Bioplate® Bone Plating System for Craniomaxillofacial Surgery, Biolactate™ Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051845 | The Bioplate Resorbable Endobrow Fixation System | 2005 | 1 |
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, K051845 (Bioplate, Inc., 2005) has gone furthest, with 1 descendant of its own.
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?
Bioplate Resorbable Bone Screws are intended for use in conjunction with Codman CRANIOSORB™ plates and meshes in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton in which resorbable fixation is desired. The plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The Bioplate Resorbable Bone Screws are intended for minimally load bearing fixation for the following indications:
Reconstructive procedures of the craniomaxillofacial skeleton
Repair of Craniofacial fractures
Cranial bone fixation
Brow lift procedures
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/K012908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012908: Bioplate Resorbable Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012908
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026