510(k) · Cleared
ClearedPowerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · DZI Drill, Bone, Powered
Cleared on Nov 10, 2003 as substantially equivalent to K832187 (Amsco Co., 1983) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1983. 6 later devices descend from it.
- Decided
- Nov 10, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K832187 (1983). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK832187 Hall OscillatorAmsco Co. · 1983
- This deviceK032607 Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185Linvatec Corp. · 2003
- 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 |
|---|---|---|---|---|---|
| −1 | K832187 | Hall Oscillator | Amsco Co. | 1983 | — |
| 0 (this device) | K032607 | Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185 | Linvatec Corp. | 2003 | — |
| +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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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? (3)
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 | K981269 | FDA’s K981269 is Universal Drive System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
| * | K832187 | Hall OscillatorSummary page 2…gally Marketed Devices PowerProB Electric System 51O(k) #Kg81269 Linvatec Corporation Hall@Surgical Series 4@ System 51 O(k) #K832187 Linvatec Corporation Midas Rex Legend System 51O(k) #KO20069 Medtronic Midas Rex E. Device D… | 1983 |
| * | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend… | 2002 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062842 | Twist Drill | 2006 | 5 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 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 PowerPro@ Pneumatic System consists of handpieces and attachments intended to be used for cutting, drilling, tapping, reaming, and driving screws and pins in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032607 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032607: Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032607
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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