510(k) Report

510(k) · Cleared

Cleared

Hall (R) Micro E Powered Surgical Instrument Syst

K864929510(k) TraditionalCleared Jan 28, 198743-day reviewClass I21 CFR 878.4820

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

Hall Surgical, Division of Zimmer, Inc. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Cleared on Jan 28, 1987 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jan 28, 1987
Review
43 days
Class
Class I
Product code
HWE
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK864929 Hall (R) Micro E Powered Surgical Instrument SystHall Surgical, Division of Zimmer, Inc. · 1987
  2. Descendant · cites it directly · 0 of its ownK960473 Aesculap Power System HandpieceAesculap, Inc. · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K960473Aesculap Power System HandpieceAesculap, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864929Hall (R) Micro E Powered Surgical Instrument SystHall Surgical, Division of Zimmer, Inc.1987—
+1K960473Aesculap Power System HandpieceAesculap, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K864929, 1987–1996Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (1)

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

NumberDeviceApplicantDecidedDescendants
K960473Aesculap Power System HandpieceAesculap, Inc.19960

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, K960473 (Aesculap, Inc., 1996) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HWE devices

HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWE

1in 2015

2007: 12011: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWE

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

Recalls per year · HWE

1in 2017

2009: 42010: 22011: 22013: 12014: 32015: 52016: 22017: 1
2007high 5 (2015) · low 0 (2007)2026

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

Adverse event reports per year · HWE

2,848in 2025

2007: 1232008: 722009: 1802010: 2972011: 1382012: 2212013: 1,2432014: 3,7942015: 5,5672016: 4,9742017: 5,0742018: 3,5892019: 3,4522020: 3,2482021: 3,1402022: 3,3272023: 3,3972024: 3,6862025: 2,848
2007high 5,567 (2015) · low 72 (2008)2025

MAUDE reports naming product code HWE, 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—0123
20080—072
20090—4180
20100—2297
20111—2138
20120—0221
20130—11,243
20140—33,794
20151—55,567
20160—24,974
20170—15,074
20180—03,589
20190—03,452
20200—03,248
20210—03,140
20220—03,327
20230—03,397
20240—03,686
20250—02,848
20260—0—

More from Hall Surgical, Division of Zimmer, Inc.

8 FDA decisions under this applicant name. See the company

  • K942660Hall Microchoice Electric Powered SystemHall Surgical, Division of Zimmer, Inc. · 19941 recall
  • K864734Hall Oral Implant SystemHall Surgical, Division of Zimmer, Inc. · 1987
  • K864163Hall Dunbar Drill Guide SystemHall Surgical, Division of Zimmer, Inc. · 1986
  • K862778Hall Cannlula SystemHall Surgical, Division of Zimmer, Inc. · 1986
  • K862474Hall Sternum SawHall Surgical, Division of Zimmer, Inc. · 1986

Recent decisions in HWE

The HWE category page

  • K143191IntelliSense DrillMcginley Innovations · 2015
  • K102743Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresOrtho Solutions Limited · 2011
  • K063688Surgical Irrigation System, Irrigation TubeThe Anspach Effort, Inc. · 2007
  • K050766Explant Osteonecrosis Intervention Implant Removal SystemZimmer Trabecular · 2005
  • K043310Synthes (Usa) Electric Pen Drive SystemSynthes (Usa) · 20052 Class I recalls

https://510kreport.com/device/K864929 · printed Nov 5, 2026

Cite this page

510(k) Report. “K864929: Hall (R) Micro E Powered Surgical Instrument Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K864929

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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