510(k) Report

510(k) · Cleared

Cleared

Hall Sternum Saw

K862474510(k) TraditionalCleared Jul 17, 198617-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. · DWH Blade, Saw, Surgical, Cardiovascular

Cleared on Jul 17, 1986 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 479 devices in its family, counting itself, has a Class I recall. 478 later devices descend from it.

Decided
Jul 17, 1986
Review
17 days
Class
Class I
Product code
DWH
Recalls
None
Predicates
0

478 later devices descend from it, 1 citing it directly. 1 of the 479 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1999: 1 descendant cleared2001: 5 descendants cleared2009: 2 descendants cleared2006: 3 descendants cleared2010: 3 descendants cleared2008: 2 descendants cleared2002: 1 descendant cleared2017: 16 descendants cleared2013: 6 descendants cleared2021: 45 descendants cleared, 1 with a Class I recall12015: 8 descendants cleared2012: 2 descendants cleared2011: 1 descendant cleared2024: 64 descendants cleared2014: 4 descendants cleared2016: 11 descendants cleared2018: 19 descendants cleared2019: 27 descendants cleared2026: 56 descendants cleared2020: 24 descendants cleared2023: 64 descendants cleared2022: 47 descendants cleared2025: 67 descendants cleared1990200020102020
  1. This deviceK862474 Hall Sternum SawHall Surgical, Division of Zimmer, Inc. · 1986
  2. Descendant · cites it directly · 477 of its ownK990524 E9000 SystemLinvatec Corp. · 1999
  3. Descendant · 2 generations on · 447 of its ownK012453 Sodem High Speed System (Electric) (General Orthopedics & Plastic…Sodemsystems · 2001
  4. Descendant · 2 generations on · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
  5. Descendant · 2 generations on · 446 of its ownK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
  6. Descendant · 3 generations on · 443 of its ownK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled

Showing 5 of 478 descendants. See all descendants

Descendants cleared per year

1999: 12001: 52002: 12006: 32008: 22009: 22010: 32011: 12012: 22013: 62014: 42015: 82016: 112017: 162018: 192019: 272020: 242021: 452022: 472023: 642024: 642025: 672026: 56
1999high 67 (2025) · low 0 (2000)2026

Class I recalls in this family

  • K211616 ExcelsiusHub9 generations on · 2021

Most influential descendants

Showing 5 of 478 · See all
  • K990524E9000 SystemLinvatec Corp. · 1999 · cites it directly477descendants
  • K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems · 2001 · 2 generations on447descendants
  • K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · 2 generations on447descendants
  • K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001 · 2 generations on446descendants
  • K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · 3 generations on443descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862474Hall Sternum SawHall Surgical, Division of Zimmer, Inc.1986—
+1K990524E9000 SystemLinvatec Corp.1999—
+2K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems2001—
+2K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001—
+2K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems2001—
+3K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc.20083

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200150
200210
200630
200820
200920
201030
201110
201220
201360
201440
201580
2016110
2017160
2018190
2019270
2020240
2021451
2022470
2023640
2024640
2025670
2026560
FIG. 1 — Lineage of K862474, 1986–2026Source: 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), 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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (478)

See all 478

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

NumberDeviceApplicantDecidedDescendants
K990524E9000 SystemLinvatec Corp.1999477

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

What does this lineage say?

  • Of its descendants, K990524 (Linvatec Corp., 1999) has gone furthest, with 477 descendants of its own.

How does its category compare?

All DWH devices

DWH Blade, Saw, Surgical, Cardiovascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWH

FDA has decided no DWH device since 2007.

Median 510(k) review, days · DWH

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

Recalls per year · DWH

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DWH

1in 2025

2007: 22008: 302009: 142010: 172011: 22012: 112013: 72014: 52015: 62016: 12017: 32018: 12019: 12020: 22021: 22022: 102023: 22024: 22025: 1
2007high 30 (2008) · low 1 (2016)2025

MAUDE reports naming product code DWH, 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—02
20080—030
20090—014
20100—017
20110—12
20120—011
20130—07
20140—05
20150—06
20160—01
20170—03
20180—01
20190—01
20200—02
20210—02
20220—010
20230—02
20240—02
20250—01
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
  • K864929Hall (R) Micro E Powered Surgical Instrument SystHall 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

Recent decisions in DWH

The DWH category page

  • K904352Codman Collins Radioparent Sternal BladesCodman & Shurtleff, Inc. · 1990
  • K850483Micro-Aire Sternum Saw Replacement BladesMicro-Aire Surgical Instruments, Inc. · 1985
  • K830189Cardiovascular Saw BladesTemp Medical Products, Inc. · 1983

https://510kreport.com/device/K862474 · printed Nov 5, 2026

Cite this page

510(k) Report. “K862474: Hall Sternum Saw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K862474

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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