510(k) Report

510(k) · Cleared

Cleared

Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax High Speed Drill

K072706510(k) SpecialCleared Oct 24, 200730-day reviewClass II21 CFR 888.1100

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

Conmed Linvatec · HRX Arthroscope

Cleared on Oct 24, 2007 as substantially equivalent to K971059 (Linvatec Corp., 1997) and 3 other predicates after a 30-day review. Its family tree reaches back 4 generations to 1986. 3 later devices descend from it.

Decided
Oct 24, 2007
Review
30 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K862807 (1986). 10 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors1994: 2 other ancestors1995: 2 other ancestors2008: 1 descendant cleared2010: 1 descendant cleared2021: 1 descendant clearedK862807 · Treace Drill System · Treace Medical, Inc. · 1986×2: 2 generations cleared close together, K964548 (1997), K971059 (1997) K060260 · Micropower Hand Piece High Speed Drill · Linvatec Corp. · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K060260 · Micropower Hand Piece High Speed Drill · Linvatec Corp. · 2006K971059 · Universal Drive System · Linvatec Corp. · 1997K964548 · Apex Universal Drive System · Linvatec Corp. · 1997K862807 · Treace Drill System · Treace Medical, Inc. · 19860
  1. Root · 4 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
  2. 3 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
  3. 2 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
  4. 1 generation backK060260 Micropower Hand Piece High Speed DrillLinvatec Corp. · 2006
  5. This deviceK072706 Microchoice Drills and Saws, Micropower Drills and Saws, Micropower…Conmed Linvatec · 2007
  6. Descendant · cites it directly · 1 of its ownK092977 Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010
  7. Descendant · 2 generations on · 0 of its ownK193608 EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021
  8. Descendant · cites it directly · 0 of its ownK080444 Conmed Linvatec Osprey Drill SystemConmed Linvatec · 2008

Most influential descendants

Showing 3 of 3 · See all
  • K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010 · cites it directly1descendant
  • K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021 · 2 generations on0descendants
  • K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K862807Treace Drill SystemTreace Medical, Inc.1986—
−3K964548Apex Universal Drive SystemLinvatec Corp.1997—
−2K971059Universal Drive SystemLinvatec Corp.1997—
−1K060260Micropower Hand Piece High Speed DrillLinvatec Corp.2006—
0 (this device)K072706Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax…Conmed Linvatec2007—
+1K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme2010—
+2K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG2021—
+1K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199520
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
202110
FIG. 1 — Lineage of K072706, 1986–2021Source: 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 HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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? (4)

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
*K971059Universal Drive System
Summary page 2
…ece Systems D. Predicate/Legally Marketed Devices 510(k) Name 510(k # Owner Universal Drive System K971059 Linvatec Corporation MicroPower Hand Piece: Medium Speed…
Linvatec Corp.1997—
*K060198Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, and…
Summary page 2
…K971059 Linvatec Corporation MicroPower Hand Piece: Medium Speed K060198 Linvatec Drill, Sagittal Saw, Reciprocating Saw, and Corporation Oscillating Saw MicroPower Hand Pie…
Linvatec Corp.2006—
*K060260Micropower Hand Piece High Speed Drill
Summary page 2
…K060198 Linvatec Drill, Sagittal Saw, Reciprocating Saw, and Corporation Oscillating Saw MicroPower Hand Piece:High Speed Drill K060260 Linvatec Corporation MicroPower Hand Piece:Oral Max High…
Linvatec Corp.2006—
*K060270Micropower Hand Piece: Oral Max High Speed Drill
Summary page 2
…Speed Drill K060260 Linvatec Corporation MicroPower Hand Piece:Oral Max High K060270 Linvatec Speed Drill Corporation E. Device Description The MicroPo…
Linvatec Corp.2006—

Also cleared against K971059: 10 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme20101
K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec20080

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?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K092977 (Efs Eberle Feinwerktechnische Systeme, 2010) has gone furthest, with 1 descendant of its own.
  • 10 other devices also cite its predicate K971059.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

What is it indicated for?

The MicroPower®Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures. The MicroPower®OraeMax Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces…

Read the full statement (109 words)

The MicroPower®Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.

The MicroPower®OraeMax Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.

The MicroChoice®Handpiece System functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, otolaryngological, oral/maxillofacial, hand, foot, neuro, and plastic/reconstructive surgical procedures.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072706: Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax High Speed Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072706

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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