Cleared Traditional

K012652 - REPROCESSED DYONICS ARTHROSCOPIC BURS

K012652 is an FDA 510(k) clearance for REPROCESSED DYONICS ARTHROSCOPIC BURS, manufactured by Alliance Medical Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K012652 · Alliance Medical Corp. · Orthopedic device
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Nov 2001
Decision
87d
Days
Class 2
Risk

K012652 is an FDA 510(k) clearance for the REPROCESSED DYONICS ARTHROSCOPIC BURS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on November 8, 2001 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alliance Medical Corp. devices

FDA 510(k) Submission Details - K012652

510(k) Number K012652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date November 08, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 393
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K012652.
ENDIUS ATAVI SYSTEM
K021748 · Endius, Inc. · Jun 2002
POWER TEK II
K020761 · Biomet, Inc. · Apr 2002
RESECTION ABLATOR
K013117 · Linvatec Corp. · Nov 2001
REPROCESSED ATHROSCOPICS BURS
K012605 · Alliance Medical Corp. · Nov 2001
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
K012635 · Alliance Medical Corp. · Nov 2001
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
K012536 · Sterilmed, Inc. · Nov 2001