510(k) · Cleared
Recalled · 2009Universal Drive System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HRX Arthroscope
Cleared on Jun 24, 1998 as substantially equivalent to K971059 (Linvatec Corp., 1997) and 2 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1986. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 24, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 3 generations to K862807 (1986). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 2 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 1 generation backK971059 Universal Drive SystemLinvatec Corp. · 1997
- This deviceK981269 Universal Drive SystemLinvatec Corp. · 1998
- Descendant · cites it directly · 0 of its ownK012630 Reprocessed Linvatec Arthroscopic BursAlliance Medical, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK012613 Reprocssed Linvatec ShaversAlliance Medical, Inc. · 2001 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −2 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −1 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| 0 (this device) | K981269 | Universal Drive System | Linvatec Corp. | 1998 | — |
| +1 | K012630 | Reprocessed Linvatec Arthroscopic Burs | Alliance Medical, Inc. | 2001 | — |
| +1 | K012613 | Reprocssed Linvatec Shavers | Alliance Medical, Inc. | 2001 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971059 | Universal Drive SystemSummary page 2…handpieces described in the predicate information. The accessories used with the system include shavers, blades, burrs, drills, and routers as described in 510 (k) # K971059. Summary of Safety and Effectiveness Universal Drive System 510(k) # April 6, 1998 Page 3 of 4 F. Intended Us… | 1997 |
| * | K895198 | Hall Versipower Surgical Instrument SystemSummary page 4…of: drills and saws which are powered either Linvatec Versipower® Plus |during Orthopedic Procedures. by battery or electric console. Large Bone . o 510 (k) Instrument #K895198 System PREDICATE | 3M Maxi-Driver Drill, Ream, and Cut.large bone | System consists of: Controller, handpiece, and interchangeabl… | 1989 |
| * | K951118 | 3M Maxi-Driver II Electric SystemSummary page 4…ne | System consists of: Controller, handpiece, and interchangeable 3M Health |Electric Powered |during Orthopedic Procedures attachments. Care Instrument 510 (k) System K951118 \ 4 SERVICE, o X‘OJ. % 5 WEALTH O G‘, —/é DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food an… | 1995 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2009 | Not classified | Z-1952-2009 | Device Design | There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008. |
| Jul 31, 2009 | Not classified | Z-1951-2009 | Device Design | There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008. |
| Jul 31, 2009 | Not classified | Z-1950-2009 | Device Design | There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K012630 (Alliance Medical, Inc., 2001) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K971059.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Universal Drive System functions as a powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Arthroscopic, Otolaryngological, Oral/Maxillofacial, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.
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/K981269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981269: Universal Drive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981269
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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