510(k) · Cleared
ClearedBone Block Fixation Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA, Inc. · DZL Screw, Fixation, Intraosseous
Cleared on Apr 5, 2005 after a 35-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it.
- Decided
- Apr 5, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
5 later devices descend from it, 1 citing it directly.
- This deviceK050515 Bone Block Fixation SetStraumann USA, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK063769 Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007
- Descendant · 2 generations on · 3 of its ownK141764 Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014
- Descendant · 3 generations on · 2 of its ownK170697 GBR systemSurgident · 2018
- Descendant · 4 generations on · 0 of its ownK222367 Save GBRDentis Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K063769Alpha Bio Bone Fixation Screw SystemAlpha-Bio Tec, Ltd. · 2007 · cites it directly4descendants
- K141764Tristar Bone Graft Fixation SystemImpladent, Ltd. · 2014 · 2 generations on3descendants
- K170697GBR systemSurgident · 2018 · 3 generations on2descendants
- K222367Save GBRDentis Co., Ltd. · 2023 · 4 generations on0descendants
- K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050515 | Bone Block Fixation Set | Straumann USA, Inc. | 2005 | — |
| +1 | K063769 | Alpha Bio Bone Fixation Screw System | Alpha-Bio Tec, Ltd. | 2007 | — |
| +2 | K141764 | Tristar Bone Graft Fixation System | Impladent, Ltd. | 2014 | — |
| +3 | K170697 | GBR system | Surgident | 2018 | — |
| +4 | K222367 | Save GBR | Dentis Co., Ltd. | 2023 | — |
| +4 | K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K010698 | Guided Bone Regeneration System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063769 | Alpha Bio Bone Fixation Screw System | 2007 | 4 |
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, K063769 (Alpha-Bio Tec, Ltd., 2007) has gone furthest, with 4 descendants 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?
Straumann Bone Block Fixation is used to stabilize and fixate bone grafts and bone filling materials for the regeneration of bone in the oral cavity. The bone grafting fixation technique can make it possible for the placement of dental implants in previously unsuitable sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050515: Bone Block Fixation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050515
Report an extraction error
Are you the manufacturer?
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