Cleared Traditional

K862658 - CONCEPT ARTHROSCOPIC KNIFE

K862658 is an FDA 510(k) clearance for CONCEPT ARTHROSCOPIC KNIFE, manufactured by Concept, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K862658 · Concept, Inc. · Orthopedic device
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Jul 1986
Decision
9d
Days
Class 2
Risk

K862658 is an FDA 510(k) clearance for the CONCEPT ARTHROSCOPIC KNIFE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on July 23, 1986 after a review of 9 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 Concept, Inc. devices

FDA 510(k) Submission Details - K862658

510(k) Number K862658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1986
Decision Date July 23, 1986
Days to Decision 9 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 122d · This submission: 9d
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 K862658.
AMERICAN EDWARDS 4.0 MM ARTHROSCOPE
K863597 · American Edwards Laboratories · Sep 1986
CONCEPT INTRAVISION ARTHROSCOPE SYSTEM
K863396 · Concept, Inc. · Sep 1986
CONCEPT CURETTE
K862657 · Concept, Inc. · Jul 1986
CABOT VIDEOSCOPE
K861859 · Cabot Medical Corp. · May 1986
ARTHROSCOPE W/CANNULATED OBTUR/DRILL BITS & WRENCH
K861268 · Orthopedic Systems, Inc. · May 1986
AMERICAN EDWARDS LABORATORIES FLEXISCOPE
K852759 · American Edwards Laboratories · Aug 1985