# K053526: Microspeed Uni Motor System

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: Jan 18, 2006 after 30 days
- Product code: HBC (Motor, Drill, Electric)
- Device class: 2
- Regulation: 21 CFR 882.4360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943589 (1994). 2 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003612: Microspeed EC Motorsystem GD650/GD653, Aesculap, Inc. (2001) Summary page 1.
- K943589: Stryker Total Performance System, Stryker Corp. (1994) Summary page 1.

## Most influential descendants
- K132264: PRIMADO2 Total Surgical System (2013), 6 descendants of its own
- K152960: ELAN 4 Motor System (2016), 3 descendants of its own
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own
- K213221: AMADEO, M-UK1015 (incl. attachments and accessories) (2022), 1 descendant of its own
- K202120: P300 Attachment (2021), 1 descendant of its own

## Recalls of this device
- Nov 22, 2010 · Not classified · Z-1474-2011: Potential safety issue in that the control box can misinterpret the information sent from the low speed motor if the control magnet inside the motor changes its posthion.

## Indications for use
Aesculap's Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

Source page: https://510kreport.com/device/K053526
Methodology: https://510kreport.com/methodology