Cleared Traditional

K012536 - REPROCESSED POWERED ARTHROSCOPIC ACCESS...

K012536 is the FDA 510(k) clearance for REPROCESSED POWERED ARTHROSCOPIC ACCESS... by Sterilmed, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K012536 · Sterilmed, Inc. · Orthopedic device
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Nov 2001
Decision
87d
Days
Class 2
Risk

K012536 is an FDA 510(k) clearance for the REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on November 2, 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K012536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date November 02, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
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.

Device Classification

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 379
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K012536.
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
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346 · Vanguard Medical Concepts, Inc. · Oct 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND
K011083 · Arthrocare Corp. · Jun 2001