510(k) · Cleared
ClearedApex Universal Drive System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Jan 17, 1997 as substantially equivalent to K944476 (Linvatec Corp., 1994) and 3 other predicates after a 65-day review. Its family tree reaches back 1 generation to 1986. 1 of the 494 devices in its family, counting itself, has a Class I recall. 489 later devices descend from it.
- Decided
- Jan 17, 1997
- Review
- 65 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K862807 (1986). 4 ancestors in all. 489 later devices descend from it, 1 citing it directly. 1 of the 494 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- This deviceK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- Descendant · cites it directly · 488 of its ownK971059 Universal Drive SystemLinvatec Corp. · 1997
- Descendant · 2 generations on · 478 of its ownK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- Descendant · 2 generations on · 477 of its ownK990524 E9000 SystemLinvatec Corp. · 1999
- Descendant · 3 generations on · 447 of its ownK012453 Sodem High Speed System (Electric) (General Orthopedics & Plastic…Sodemsystems · 2001
- Descendant · 3 generations on · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
Showing 5 of 489 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub10 generations on · 2021
Most influential descendants
Showing 5 of 489 · See all- K971059Universal Drive SystemLinvatec Corp. · 1997 · cites it directly488descendants
- K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998 · 2 generations on478descendants
- K990524E9000 SystemLinvatec Corp. · 1999 · 2 generations on477descendants
- K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems · 2001 · 3 generations on447descendants
- K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · 3 generations on447descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| 0 (this device) | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| +1 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| +2 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| +2 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| +3 | K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | Sodemsystems | 2001 | — |
| +3 | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | Sodemsystems | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 11 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 27 | 0 |
| 2020 | 24 | 0 |
| 2021 | 45 | 1 |
| 2022 | 47 | 0 |
| 2023 | 64 | 0 |
| 2024 | 64 | 0 |
| 2025 | 67 | 0 |
| 2026 | 56 | 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.
1 device in this family has a Class I recall. 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K944476 | Apex Universal Drive SystemSummary page 3…: 2,500 rpm — T e . . L (RDIC) Apex™ Universal and : peed Drive System econstructive axinum rorward/nnvorses 3,500 rpm Linvatec urgery imum Oscillate: 1,500 rpm 510(k) # 944476 : e — : traightehot™ "aximum !orwardig@%gwgae 5,000 zpm Xomed icre Resector Maximum Osciliate: 3,000 zpm : Bndoscopy [System H x… | 1994 |
| * | K862807 | Treace Drill System | 1986 |
| * | K954796 | Micro-Ingressor HandipieceSummary page 3…00 rpm 510(k) # 944476 : e — : traightehot™ "aximum !orwardig@%gwgae 5,000 zpm Xomed icre Resector Maximum Osciliate: 3,000 zpm : Bndoscopy [System H x 510 (k) # B62807 954796 960886 EATE Dyonics® EP1 NT d: Surgical Drive imum Forward/Reverse: 8, 000 rpm Smith and |gystem aximum Oscillate: 3,000 rpm ephe… | 1995 |
| Kept off the family tree | K960886 | FDA’s K960886 is Steri-Oss 6 MM Diameter HA Coated Implants Our OCR of the scanned summary read K960886, FDA’s number for Steri-Oss 6 MM Diameter HA Coated Implants (Steri-Oss, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “XPS™ Straightshot Micro Resector System”. Kept off the family tree. Summary page 3…510(k) # 944476 : e — : traightehot™ "aximum !orwardig@%gwgae 5,000 zpm Xomed icre Resector Maximum Osciliate: 3,000 zpm : Bndoscopy [System H x 510 (k) # B62807 954796 960886 EATE Dyonics® EP1 NT d: Surgical Drive imum Forward/Reverse: 8, 000 rpm Smith and |gystem aximum Oscillate: 3,000 rpm ephew ndosc… | 1996 |
| * | K954989 | Dyonics Disposable Endoscopic Surgery BladesSummary page 3…(k) # B62807 954796 960886 EATE Dyonics® EP1 NT d: Surgical Drive imum Forward/Reverse: 8, 000 rpm Smith and |gystem aximum Oscillate: 3,000 rpm ephew ndoscopy 510(k) # 954989 | 1995 |
What descends from it? (489)
See all 4891 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971059 | Universal Drive System | 1997 | 488 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 10 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and reconstructive surgery. The drive system is reusable.
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/K964548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964548: Apex Universal Drive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964548
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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