Cleared Traditional

K012611 - REPROCESSED DYONICS ARTHROSCOPIC SHAVERS

K012611 is an FDA 510(k) clearance for REPROCESSED DYONICS ARTHROSCOPIC SHAVERS, manufactured by Alliance Medical, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K012611 · Alliance Medical, Inc. · Orthopedic device
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Nov 2001
Decision
86d
Days
Class 2
Risk

K012611 is an FDA 510(k) clearance for the REPROCESSED DYONICS ARTHROSCOPIC SHAVERS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Alliance Medical, Inc. (Phoenix, US). The FDA issued a Cleared decision on November 7, 2001 after a review of 86 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, Inc. devices

FDA 510(k) Submission Details - K012611

510(k) Number K012611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date November 07, 2001
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 122d · This submission: 86d
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 487
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K012611.
RESECTION ABLATOR
K013117 · Linvatec Corp. · Nov 2001
REPROCESSED DYONICS ARTHROSCOPIC BURS
K012652 · Alliance Medical 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
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346 · Vanguard Medical Concepts, Inc. · Oct 2001