510(k) · Cleared
ClearedOsteoMed PINNACLE Driver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed · KMW Handpiece, Rotary Bone Cutting
Cleared on Apr 4, 2017 as substantially equivalent to K933101 (Osteomed Corp., 1994) after a 204-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 4, 2017
- Review
- 204 days
- Class
- Class II
- Product code
- KMW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933101 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK933101 The Osteomed B Power System and AccessoriesOsteomed Corp. · 1994
- This deviceK162544 OsteoMed PINNACLE DriverOsteomed · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933101 | The Osteomed B Power System and Accessories | Osteomed Corp. | 1994 | — |
| 0 (this device) | K162544 | OsteoMed PINNACLE Driver | Osteomed | 2017 | — |
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 KMW? 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 KMW device
- #1 K211584 Oral Surgery Contrascore 2.8 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K933101 | The Osteomed B Power System and AccessoriesSummary page 4…me: Drill, Bone, Powered Regulation: 872.4120 Regulatory Class: II Product Code: KMW III. PREDICATE DEVICE The OsteoMed “B” Power System, K933101, is the primary predicate. The OsteoMed OsteoPower System, K971692, is the reference predicate. This primary predi… | 1994 |
| † | K971692 | Osteopower System and Accessories | 1997 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K933101.
How does its category compare?
All KMW devicesKMW Handpiece, Rotary Bone Cutting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KMW
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KMW
Too few KMW 510(k)s in any year since 2007 to give a median.
Recalls per year · KMW
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMW
22in 2025
MAUDE reports naming product code KMW, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 0 | — | 8 | 16 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 1 | — | 1 | 32 |
| 2022 | 0 | — | 0 | 54 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with dental, orthognathic, and mandibular surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162544 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162544: OsteoMed PINNACLE Driver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162544
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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