510(k) Report

510(k) · Cleared

Cleared

Reprocessed Used, Disposable Blades, Burs, Bits and Taps

K012676510(k) TraditionalCleared Feb 4, 2002174-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

Adven Medical · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Cleared on Feb 4, 2002 after a 174-day review. The FDA summary names its predicate without a number.

Decided
Feb 4, 2002
Review
174 days
Class
Class I
Product code
HWE
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K012676Source: 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), 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 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? (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
*—Disposable blades, burs, bits and taps marketed by Stryker
Named without a submission number
—
*—Disposable blades, burs, bits and taps marketed by Microair
Named without a submission number
—
*—Disposable blades, burs, bits and taps marketed by Synthes
Named without a submission number
—
*—Disposable blades, burs, bits and taps marketed by Komet
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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.

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—

What is it indicated for?

Blades, burs, bits and taps are metal accessories and attachments used with powered surgical tools for re-constructive and traumatic bone surgery.

AMI intends to repr all brands of used disposable surglcal saw blades, burs, bits and taps. Reprocessing includes all the steps performed to make a contaminated single use device patient ready.

Only blades, burs, bits and taps that are currently sold on the market (which have met premarket requirements by the Joriginal manufacturer for single use) will be reprocessed by AMI.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Adven Medical

6 FDA decisions under this applicant name. See the company

  • K021528Reprocessed Venodyne Sequential Compression Sleeves / WrapAdven Medical · 2002
  • K013987Reprocessed Disposable TrocarsAdven Medical · 2002
  • K012675Reprocessed Used Disposable Sequential Compression Sleeves/WrapsAdven Medical · 2002
  • K012694Reprocessed Used Disposable Arthroscopic Blades and BursAdven Medical · 2002
  • K940501RE-Sharpenable Saw BladesAdven Medical · 1994

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/K012676 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012676: Reprocessed Used, Disposable Blades, Burs, Bits and Taps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012676

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Page last updated Nov 3, 2026