510(k) · Cleared
ClearedStryker Oral Max System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · DZI Drill, Bone, Powered
Cleared on Aug 20, 1996 after a 314-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Aug 20, 1996
- Review
- 314 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK954690 Stryker Oral Max SystemStryker Corp. · 1996
- Descendant · cites it directly · 5 of its ownK062842 Twist DrillWalter Lorenz Surgical, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 1 of its ownK213072 2.1 x 255mm Drill, 22mm StopBiomet Micofixation · 2022
- Descendant · 3 generations on · 0 of its ownK223199 2.1 x 255mm Drill, 22mm StopBiomet Microfixation · 2022
- Descendant · 2 generations on · 0 of its ownK213208 Twist DrillsBiomet Microfixation · 2021
- Descendant · 2 generations on · 0 of its ownK170442 Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation · 2017 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K062842Twist DrillWalter Lorenz Surgical, Inc. · 2006 · cites it directly5descendants
- K2130722.1 x 255mm Drill, 22mm StopBiomet Micofixation · 2022 · 2 generations on1descendant
- K2231992.1 x 255mm Drill, 22mm StopBiomet Microfixation · 2022 · 3 generations on0descendants
- K213208Twist DrillsBiomet Microfixation · 2021 · 2 generations on0descendants
- K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954690 | Stryker Oral Max System | Stryker Corp. | 1996 | — |
| +1 | K062842 | Twist Drill | Walter Lorenz Surgical, Inc. | 2006 | 1 |
| +2 | K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | 2022 | — |
| +3 | K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | 2022 | — |
| +2 | K213208 | Twist Drills | Biomet Microfixation | 2021 | — |
| +2 | K170442 | Cranial Drill Bits and Accessories | Ad-Tech Medical Instrument Corporation | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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 DZI? 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 DZI device
- #1 K253776 Implantmed Plus II & Piezomed Plus II Modulescore 12.1 · 3 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 |
|---|---|---|---|
| * | — | powered instruments, controls, and associated accessories marketed by Stryker prior to… Named without a submission number | |
| * | — | power sources distributed by Aseptico Named without a submission number |
What descends from it? (6)
2 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?
- Of its descendants, K062842 (Walter Lorenz Surgical, Inc., 2006) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZI
300in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZI
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZI
39in 2025
MAUDE reports naming product code DZI, 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 | 2 | — | 0 | 53 |
| 2008 | 4 | 171 | 0 | 45 |
| 2009 | 5 | 220 | 1 | 22 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 4 | 191 | 0 | 25 |
| 2013 | 0 | — | 0 | 57 |
| 2014 | 1 | — | 0 | 50 |
| 2015 | 3 | 123 | 0 | 39 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 3 | 290 | 0 | 73 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 3 | 300 | 0 | 55 |
| 2021 | 0 | — | 0 | 84 |
| 2022 | 0 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 63 |
| 2024 | 2 | — | 0 | 58 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Oral Max System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including but not limited to, dental and oral surgery It is also usable in the placement of screws.
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/K954690 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954690: Stryker Oral Max System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954690
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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