# K964548: Apex Universal Drive System

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jan 17, 1997 after 65 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862807 (1986). 4 ancestors in all.
489 later devices descend from it; 1 cites it directly.
1 of 494 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944476: Apex Universal Drive System, Linvatec Corp. (1994) Summary page 3.
- K862807: Treace Drill System, Treace Medical, Inc. (1986)
- K954796: Micro-Ingressor Handipiece, Trebay Medical Corp. (1995) Summary page 3.
- K954989: Dyonics Disposable Endoscopic Surgery Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 3.

## Cited in the summary but kept off the family tree
- K960886: Steri-Oss 6 MM Diameter HA Coated Implants, Steri-Oss, Inc. (1996). 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.

## Most influential descendants
- K971059: Universal Drive System (1997), 488 descendants of its own
- K981637: Integrated Drive/Pump System for Otolaryngology (1998), 478 descendants of its own
- K990524: E9000 System (1999), 477 descendants of its own
- K012453: Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) (2001), 447 descendants of its own
- K012457: Sodem High Speed System (Electric) (Neuro/Spine Surgery) (2001), 447 descendants of its own

## Indications for use
The Apex Universal Drive System is utilized for shaving of soft tissue and bone during otolaryngological and reconstructive surgery. The drive system is reusable.

Source page: https://510kreport.com/device/K964548
Methodology: https://510kreport.com/methodology