510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Stryker Footed Attachments and Cutting Accessories

K143399510(k) TraditionalCleared May 8, 2015161-day reviewClass II21 CFR 882.4310Recalls 1

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

Stryker Corp. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

Cleared on May 8, 2015 as substantially equivalent to K112593 (Stryker Corporation, 2012) after a 161-day review. Its family tree reaches back 1 generation to 2012. 1 later device descends from it. It has been recalled once.

Decided
May 8, 2015
Review
161 days
Class
Class II
Product code
HBE
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K112593 (2012). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant clearedReference device: K113476 · Anspach Dissection Tools · The Anspach Effort, Inc. · 2011 · recalledReference device: K081475 · Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] · Medtronic Xomed, Inc. · 2008 · recalledK112593 · Styker Consolidated Operating Room Equipment (Core) System · Stryker Corporation · 20122010201520202025
Descendants, by generation 1 generation forward: 1 descendant K112593 · Styker Consolidated Operating Room Equipment (Core) System · Stryker Corporation · 20120
  1. Root · 1 generation backK112593 Styker Consolidated Operating Room Equipment (Core) SystemStryker Corporation · 2012
  2. This deviceK143399 Stryker Footed Attachments and Cutting AccessoriesStryker Corp. · 2015
  3. Descendant · cites it directly · 0 of its ownK191049 Stryker MIS and Footed AttachmentsStryker Corporation · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K191049Stryker MIS and Footed AttachmentsStryker Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K112593Styker Consolidated Operating Room Equipment (Core) SystemStryker Corporation2012—
0 (this device)K143399Stryker Footed Attachments and Cutting AccessoriesStryker Corp.2015—
+1K191049Stryker MIS and Footed AttachmentsStryker Corporation2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K143399, 2012–2019Source: 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 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
*K112593Styker Consolidated Operating Room Equipment (Core) System
Summary page 4
…Stryker® Consolidated Operating Room Stryker K112593 ERL Equipment (CORE) Instruments…
Stryker Corporation2012—
†K113476Anspach Dissection ToolsThe Anspach Effort, Inc.201139
†K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc.20083

Also cleared against K112593: 5 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K191049Stryker MIS and Footed AttachmentsStryker Corporation20190

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 24, 2016Class IIZ-2238-2016Process designA variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K191049 (Stryker Corporation, 2019) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K112593.

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. 2015, 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 Footed Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat…

Read the full statement (116 words)

The Footed Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy.

Specific applications include Craniotomy/Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, and Orthopedic Spine.

These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

Indications for use as stated in the FDA summary.

Also cleared against K112593

5 other devices cite the same predicate.

  • K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q…Stryker Leibinger GmbH & Co KG · 2024
  • K171840Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Corporation · 2017
  • K143540Stryker MIS Attachments and Cutting AccessoriesStryker Corporation · 2015
  • K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. · 20157 recalls
  • K141935Stryker S2 DrillStryker Corporation · 2014

More from Stryker Corp.

156 FDA decisions under this applicant name. See the company

  • K230045HipCheckStryker Corp. · 2023
  • K191259Stryker CrossFlow Integrated Arthroscopy PumpStryker Corp. · 2019
  • K182359HipCheckStryker Corp. · 2018
  • P050044/S033Vitagel RT3 Sutgical HemostatStryker Corp. · 2017
  • P050044/S032Vitagel RT3 Surgical HemostatStryker Corp. · 2015

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/K143399 · printed Nov 5, 2026

Cite this page

510(k) Report. “K143399: Stryker Footed Attachments and Cutting Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143399

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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