510(k) Report

510(k) · Cleared

Cleared

Advantage Drive System

K002523510(k) TraditionalCleared Oct 6, 200052-day reviewClass II21 CFR 882.4360

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

Linvatec Corp. · HBC Motor, Drill, Electric

Cleared on Oct 6, 2000 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 463 devices in its family, counting itself, has a Class I recall. 462 later devices descend from it.

Decided
Oct 6, 2000
Review
52 days
Class
Class II
Product code
HBC
Recalls
None
Predicates
0

462 later devices descend from it, 12 citing it directly. 1 of the 463 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2008: 2 descendants cleared2006: 1 descendant cleared2001: 4 descendants cleared2002: 1 descendant cleared2005: 1 descendant cleared2010: 1 descendant cleared2009: 1 descendant cleared2016: 9 descendants cleared2017: 15 descendants cleared2013: 6 descendants cleared2015: 7 descendants cleared2012: 1 descendant cleared2011: 1 descendant cleared2024: 64 descendants cleared2014: 3 descendants cleared2021: 44 descendants cleared, 1 with a Class I recall12018: 19 descendants cleared2020: 23 descendants cleared2023: 63 descendants cleared2022: 47 descendants cleared2019: 28 descendants cleared2026: 56 descendants cleared2025: 65 descendants cleared200020052010201520202025
  1. This deviceK002523 Advantage Drive SystemLinvatec Corp. · 2000
  2. Descendant · cites it directly · 447 of its ownK012453 Sodem High Speed System (Electric) (General Orthopedics & Plastic…Sodemsystems · 2001
  3. Descendant · cites it directly · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
  4. Descendant · cites it directly · 446 of its ownK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
  5. Descendant · cites it directly · 443 of its ownK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
  6. Descendant · cites it directly · 420 of its ownK081277 XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · Recalled

Showing 5 of 462 descendants. See all descendants

Descendants cleared per year

2001: 42002: 12005: 12006: 12008: 22009: 12010: 12011: 12012: 12013: 62014: 32015: 72016: 92017: 152018: 192019: 282020: 232021: 442022: 472023: 632024: 642025: 652026: 56
2001high 65 (2025) · low 0 (2003)2026

Class I recalls in this family

  • K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 462 · See all
  • K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems · 2001 · cites it directly447descendants
  • K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · cites it directly447descendants
  • K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001 · cites it directly446descendants
  • K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · cites it directly443descendants
  • K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc. · 2008 · cites it directly420descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002523Advantage Drive SystemLinvatec Corp.2000—
+1K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems2001—
+1K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001—
+1K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems2001—
+1K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc.20083
+1K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc.20081

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200140
200210
200510
200610
200820
200910
201010
201110
201210
201360
201430
201570
201690
2017150
2018190
2019280
2020230
2021441
2022470
2023630
2024640
2025650
2026560
FIG. 1 — Lineage of K002523, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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 HBC device

  1. #1 K254174 Surgical Power Systemscore 14.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (462)

See all 462

12 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems2001447
K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001447
K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems2001446
K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc.2008443
K081277XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power CONS0LE (Ipc)Medtronic Xomed, Inc.2008420
K083112PrimadoNakanishi, Inc.20097
K161307NICO MyriadNico Corporation20164
K061134Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme20062
K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme20101
K050519Advanced Turbo Drive SystemLinvatec Corp.20051

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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K012453 (Sodemsystems, 2001) has gone furthest, with 447 descendants of its own.

How does its category compare?

All HBC devices

HBC Motor, Drill, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBC

2in 2024

2008: 12009: 12013: 22014: 12016: 12017: 22018: 12019: 12021: 12022: 22024: 22026 (partial year): 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBC

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

Recalls per year · HBC

9in 2022

2010: 12011: 92014: 12022: 9
2007high 9 (2011) · low 0 (2007)2026

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

Adverse event reports per year · HBC

635in 2025

2007: 52008: 62009: 22010: 12011: 12012: 32013: 10,6702014: 2,6432015: 1,9532016: 2,5412017: 2,0792018: 1,7792019: 1,7032020: 1,3042021: 9462022: 7602023: 6632024: 4272025: 635
2007high 10,670 (2013) · low 1 (2010)2025

MAUDE reports naming product code HBC, 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
20070—05
20081—06
20091—02
20100—11
20110—91
20120—03
20132—010,670
20141—12,643
20150—01,953
20161—02,541
20172—02,079
20181—01,779
20191—01,703
20200—01,304
20211—0946
20222—9760
20230—0663
20242—0427
20250—0635
20261—0—

More from Linvatec Corp.

93 FDA decisions under this applicant name. See the company

  • K092998Conmed Linvatec Intercept ImplantLinvatec Corp. · 2009
  • K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 20091 recall
  • K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp. · 2009
  • K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp. · 2009
  • K083281EL Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model IA-2000-S, Lightwave…Linvatec Corp. · 2009

Recent decisions in HBC

The HBC category page

  • K254174Surgical Power SystemGuizhou Zirui Technology Co., Ltd. · 2026
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https://510kreport.com/device/K002523 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002523: Advantage 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/K002523

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026