510(k) Report

510(k) · Cleared

Recalled · 2008

Carbide Cutting Instrument/Intraarticu

K802598510(k) TraditionalCleared Nov 19, 198029-day reviewClass I21 CFR 888.4540Recalls 13

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. · HTT Burr, Orthopedic

Cleared on Nov 19, 1980 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 13 times.

Decided
Nov 19, 1980
Review
29 days
Class
Class I
Product code
HTT
Recalls
13
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K802598Source: FDA 510(k) database · 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.

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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?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
May 19, 2008Not classifiedZ-0090-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0091-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0094-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0095-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0096-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0097-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0099-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0100-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0093-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0101-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0102-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0092-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
May 19, 2008Not classifiedZ-0098-2012Employee errorThe Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.

The 5 latest of 13 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All HTT devices

HTT Burr, Orthopedic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTT

FDA has decided no HTT device since 2007.

Median 510(k) review, days · HTT

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

Recalls per year · HTT

1in 2012

2008: 132009: 12010: 62012: 1
2007high 13 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HTT

2in 2023

2007: 262008: 562009: 352010: 302011: 92012: 162013: 62014: 72015: 172016: 92017: 12018: 22019: 22020: 22021: 22022: 32023: 2
2007high 56 (2008) · low 0 (2024)2025

MAUDE reports naming product code HTT, 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—026
20080—1356
20090—135
20100—630
20110—09
20120—116
20130—06
20140—07
20150—017
20160—09
20170—01
20180—02
20190—02
20200—02
20210—02
20220—03
20230—02
20240—00
20250—00
20260—0—

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 HTT

The HTT category page

  • K862529Hall Sterile BurHall Surgical, Division of Zimmer, Inc. · 1986
  • K821695Micro-Aire Replac. Drill Burs for ZimmerMicro-Aire Surgical Instruments, Inc. · 1982
  • K760236Bur, Surgical CarbideCutter Laboratories, Inc. · 1976

https://510kreport.com/device/K802598 · printed Nov 6, 2026

Cite this page

510(k) Report. “K802598: Carbide Cutting Instrument/Intraarticu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K802598

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026