510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal

K080802510(k) SpecialCleared Apr 30, 200840-day reviewClass II21 CFR 882.4310Recalls 35

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

The Anspach Effort, Inc. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

Cleared on Apr 30, 2008 as substantially equivalent to K011444 (The Anspach Effort, Inc., 2001) after a 40-day review. Its family tree reaches back 1 generation to 2001. 14 later devices descend from it. It has been recalled 35 times.

Decided
Apr 30, 2008
Review
40 days
Class
Class II
Product code
HBE
Recalls
35
Predicates
1

Its longest line of descent runs back 1 generation to K011444 (2001). 14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2018: 2 descendants cleared2011: 1 descendant cleared2019: 3 descendants cleared2014: 1 descendant cleared2024: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2025: 2 descendants cleared2026: 1 descendant clearedK011444 · Anspach Emax Drill System · The Anspach Effort, Inc. · 2001 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 8 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K011444 · Anspach Emax Drill System · The Anspach Effort, Inc. · 2001 · recalled0+5
  1. Root · 1 generation backK011444 Anspach Emax Drill SystemThe Anspach Effort, Inc. · 2001 · Recalled
  2. This deviceK080802 Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware…The Anspach Effort, Inc. · 2008
  3. Descendant · cites it directly · 13 of its ownK113476 Anspach Dissection ToolsThe Anspach Effort, Inc. · 2011 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
  5. Descendant · 3 generations on · 3 of its ownK232684 Surgify HaloSurgify Medical OY · 2023
  6. Descendant · cites it directly · 3 of its ownK173066 OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018
  7. Descendant · 4 generations on · 2 of its ownK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2011: 12014: 12018: 22019: 32022: 12023: 12024: 22025: 22026: 1
2011high 3 (2019) · low 0 (2012)2026

Most influential descendants

Showing 5 of 14 · See all
  • K113476Anspach Dissection ToolsThe Anspach Effort, Inc. · 2011 · cites it directly13descendants
  • K130755Hicut Highspeed InstrumentAdeor Medical AG · 2014 · 2 generations on4descendants
  • K232684Surgify HaloSurgify Medical OY · 2023 · 3 generations on3descendants
  • K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA · 2018 · cites it directly3descendants
  • K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY · 2025 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011444Anspach Emax Drill SystemThe Anspach Effort, Inc.200170
0 (this device)K080802Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade…The Anspach Effort, Inc.2008—
+1K113476Anspach Dissection ToolsThe Anspach Effort, Inc.201139
+2K130755Hicut Highspeed InstrumentAdeor Medical AG2014—
+3K232684Surgify HaloSurgify Medical OY2023—
+1K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA2018—
+4K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY20255

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201410
201820
201930
202210
202310
202420
202520
202610
FIG. 1 — Lineage of K080802, 2001–2026Source: 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), 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 HBE? 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 HBE device

  1. #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 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? (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
*K011444Anspach Emax Drill System
Summary page 2
…lusion The eMax 2 Plus System is substantially equivalent to the currently marketed eMax Drill System cleared by K0 11444 on August 8, 2001. The Anspach Effort, 4500 Riverside Drive, Palm Beach Gard…
The Anspach Effort, Inc.200170

Also cleared against K011444: 8 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K113476Anspach Dissection ToolsThe Anspach Effort, Inc.201113
K173066OSSEODUO Shaver and Drill SystemBien-Air Surgery SA20183

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 6, 2016Class IIZ-1949-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-2031-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1948-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-2001-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1956-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1952-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-2026-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-2019-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-2015-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-2032-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1955-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Oct 6, 2016Class IIZ-1957-2017Under Investigation by firmSupplied Directions for Use (DFU) did not contain a recommended service interval.
Dec 17, 2013Class IIZ-0726-2014Process designSome carbide cutting burr fractured during use.
Dec 17, 2013Class IIZ-0727-2014Process designSome carbide cutting burr fractured during use.
Dec 17, 2013Class IIZ-0728-2014Process designSome carbide cutting burr fractured during use.
Dec 17, 2013Class IIZ-0729-2014Process designSome carbide cutting burr fractured during use.
Nov 28, 2012Class IIZ-1892-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1880-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1893-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1891-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1879-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1889-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1885-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1878-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1886-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1888-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1877-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1887-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1890-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Nov 28, 2012Class IIZ-1881-2014Process designThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Jan 9, 2012Class IIZ-0074-2013Nonconforming Material/ComponentThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.
Jan 9, 2012Class IIZ-0076-2013Nonconforming Material/ComponentThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.
Jan 9, 2012Class IIZ-0075-2013Nonconforming Material/ComponentThe Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.
May 6, 2011Class IIZ-0200-2014Labeling Change ControlAnspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and…
Aug 13, 2009Not classifiedZ-0083-2010Device DesignThe Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the…

The 5 latest of 35 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K113476 (The Anspach Effort, Inc., 2011) has gone furthest, with 13 descendants of its own.
  • 8 other devices also cite its predicate K011444.

How does its category compare?

All HBE devices

HBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · HBE

6in 2025

2007: 22008: 22011: 22012: 12013: 12014: 22015: 32016: 22017: 22018: 22019: 52021: 62022: 22023: 22025: 62026 (partial year): 1
2007high 6 (2021) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBE

30in 2025

2015: 155 days median2019: 133 days median2021: 193 days median2025: 30 days median
2007high 193 (2021) · low 30 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HBE

1in 2024

2008: 472009: 72010: 232011: 12012: 262013: 42016: 72017: 32021: 12023: 32024: 12026 (partial year): 19
2007high 47 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HBE

1,924in 2025

2007: 142008: 142009: 2422010: 4922011: 1,0132012: 1,1462013: 1,5832014: 5592015: 4832016: 8482017: 8482018: 7872019: 8362020: 1,0252021: 1,0472022: 9002023: 9482024: 1,1532025: 1,924
2007high 1,924 (2025) · low 14 (2007)2025

MAUDE reports naming product code HBE, 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
20072—014
20082—4714
20090—7242
20100—23492
20112—11,013
20121—261,146
20131—41,583
20142—0559
201531550483
20162—7848
20172—3848
20182—0787
201951330836
20200—01,025
2021619311,047
20222—0900
20232—3948
20240—11,153
202563001,924
20261—19—

What is it indicated for?

The eMax 2 Plus System is intended for Cutting and shaping bone including spine and cranium.

Indications for use as stated in the FDA summary.

Also cleared against K011444

8 other devices cite the same predicate.

  • K133604Anspach EG1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc. · 201411 recalls
  • K131053Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemThe Anspach Effort, Inc. · 20133 recalls
  • K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec · 2008
  • K030576Anspach Irrigation Pump and Irrigation Pump IIThe Anspach Effort, Inc. · 20031 recall
  • K022986The Bioplate Battery Powered DrillBioplate, Inc. · 2002
  • K022942CraniocutAesculap, Inc. · 2002

More from The Anspach Effort, Inc.

60 FDA decisions under this applicant name. See the company

  • K220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)The Anspach Effort, Inc. · 2022
  • K183545Anspach Helix Dissection ToolsThe Anspach Effort, Inc. · 2019
  • K180063OCM-G1 AttachmentThe Anspach Effort, Inc. · 2018
  • K133604Anspach EG1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc. · 201411 recalls
  • K131053Anspach Xmax, EMAX2 and EMAX2 Plus System with Otologic Attachment SystemThe Anspach Effort, Inc. · 20133 recalls

Recent decisions in HBE

The HBE category page

  • K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo…Surgify Medical OY · 202611 recalls
  • K250815Hubly Drill (H100)Hubly, Inc. · 2025
  • K252060GREENPhasor Health, LLC · 2025
  • K252662UniBurNakanishi, Inc. · 2025
  • K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20253 recalls

https://510kreport.com/device/K080802 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080802: Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>Firmware Upgrade, Emax 2 FP Foot Pedal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080802

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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