510(k) · Cleared
ClearedBone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · DZL Screw, Fixation, Intraosseous
Cleared on Aug 13, 2025 as substantially equivalent to K182881 (Osstem Implant Co., Ltd., 2019) after an 83-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Aug 13, 2025
- Review
- 83 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K894844 (1990). 46 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 7 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 6 generations backK973353 Bonding BaseStraumann USA · 1997
- 5 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 4 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 3 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 2 generations backK050669 Jeil Bone Fixation SystemJeil Medical Corporation · 2005
- 1 generation backK182881 Bone Screw, Bone TackOsstem Implant Co., Ltd. · 2019
- This deviceK251569 Bone ScrewOsstem Implant Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −6 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −5 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −4 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −3 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −2 | K050669 | Jeil Bone Fixation System | Jeil Medical Corporation | 2005 | — |
| −1 | K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2019 | — |
| 0 (this device) | K251569 | Bone Screw | Osstem Implant Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K182881 | Bone Screw, Bone TackSummary page 5…ice Classification : Class II - Classification Product Code : DZL 3. Predicated Device(s) Primary Predicate K182881 Osstem Implant Co., Ltd. Bone Screw, Bone Tack Reference Device K201210 Ha… | 2019 |
| † | K201210 | The Micro Screw System, Micro Screw System Basic | 2021 |
| † | K172354 | OssBuilder System | 2018 |
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?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 46 ancestors has a recall of any class.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251569: Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251569
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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