# K101168: Legend Power Adapter Model: 6475000

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Aug 24, 2010 after 120 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MIDAS REX® LEGEND® System Perforator Attachment: named in the summary without a submission number

## Most influential descendants
- K111478: Stryker Spine Power Adaptor (Accessory Instrument) (2011), 34 descendants of its own
- K120434: Power Adaptor Instrument Accessory (2012), 32 descendants of its own
- K152632: XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory (2015), 31 descendants of its own
- K170496: Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory (2017), 15 descendants of its own
- K163604: SeaSpine® Daytona® Small Stature Spinal System (2017), 12 descendants of its own

## Indications for use
The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cuffing tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial, and sternotomy surgeries.

Source page: https://510kreport.com/device/K101168
Methodology: https://510kreport.com/methodology
