510(k) Report

510(k) · Cleared

Cleared

Legend Power Adapter Model: 6475000

K101168510(k) TraditionalCleared Aug 24, 2010120-day reviewClass II21 CFR 882.4370

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Sofamor Danek · HBB Motor, Drill, Pneumatic

Cleared on Aug 24, 2010 after a 120-day review. The FDA summary names its predicate without a number. 35 later devices descend from it.

Decided
Aug 24, 2010
Review
120 days
Class
Class II
Product code
HBB
Recalls
None
Predicates
0

35 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2017: 5 descendants cleared2020: 5 descendants cleared2012: 1 descendant cleared2015: 1 descendant cleared2023: 4 descendants cleared2024: 6 descendants cleared2019: 2 descendants cleared2018: 2 descendants cleared2026: 3 descendants cleared2025: 2 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2010201520202025
  1. This deviceK101168 Legend Power Adapter Model: 6475000Medtronic Sofamor Danek · 2010
  2. Descendant · cites it directly · 34 of its ownK111478 Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation · 2011
  3. Descendant · 2 generations on · 32 of its ownK120434 Power Adaptor Instrument AccessoryStryker Corp. · 2012
  4. Descendant · 3 generations on · 31 of its ownK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
  5. Descendant · 4 generations on · 15 of its ownK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
  6. Descendant · 4 generations on · 12 of its ownK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12015: 12017: 52018: 22019: 22020: 52021: 12022: 22023: 42024: 62025: 22026: 3
2011high 6 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 35 · See all
  • K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation · 2011 · cites it directly34descendants
  • K120434Power Adaptor Instrument AccessoryStryker Corp. · 2012 · 2 generations on32descendants
  • K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015 · 3 generations on31descendants
  • K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · 4 generations on15descendants
  • K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017 · 4 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K101168Legend Power Adapter Model: 6475000Medtronic Sofamor Danek2010—
+1K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation2011—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.2012—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation2015—
+4K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation20171
+4K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201510
201750
201820
201920
202050
202110
202220
202340
202460
202520
202630
FIG. 1 — Lineage of K101168, 2010–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HBB? 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 HBB device

  1. #1 K253772 Velocity Alpha MR High Speed Surgical Drill…score 11.0 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—MIDAS REX® LEGEND® System Perforator Attachment
Named without a submission number
—

What descends from it? (35)

See all 35

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K111478 (Stryker Corporation, 2011) has gone furthest, with 34 descendants of its own.

How does its category compare?

All HBB devices

HBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HBB

1in 2018

2007: 12009: 12010: 22015: 12017: 12018: 12026 (partial year): 1
2007high 2 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBB

Too few HBB 510(k)s in any year since 2007 to give a median.

Recalls per year · HBB

2in 2025

2007: 12008: 12009: 12013: 12015: 12017: 12025: 2
2007high 2 (2025) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HBB

1,016in 2025

2007: 822008: 1762009: 1962010: 1832011: 3992012: 3792013: 6852014: 5622015: 4402016: 2732017: 2032018: 2952019: 2842020: 2632021: 2602022: 1722023: 1802024: 7592025: 1,016
2007high 1,016 (2025) · low 82 (2007)2025

MAUDE reports naming product code HBB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—182
20080—1176
20091—1196
20102—0183
20110—0399
20120—0379
20130—1685
20140—0562
20151—1440
20160—0273
20171—1203
20181—0295
20190—0284
20200—0263
20210—0260
20220—0172
20230—0180
20240—0759
20250—21,016
20261—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Medtronic Sofamor Danek

154 FDA decisions under this applicant name. See the company

  • K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek · 2021
  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
  • K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
  • K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMedtronic Sofamor Danek · 2017
  • K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek · 2017

Recent decisions in HBB

The HBB category page

  • K253772Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AG · 2026
  • K172907ELAN 4 Air Motor SystemAesculap, Inc. · 20182 recalls
  • K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic…Medtronic Powered Surgical Solutions · 2017
  • K150801Stryker Maestro Air MotorsStryker Corporation · 20151 recall
  • K093361Synthes Air Pen Drive (Apd) SystemSynthes (Usa) · 2010

https://510kreport.com/device/K101168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101168: Legend Power Adapter Model: 6475000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101168

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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