Cleared Traditional

K855216 - 3M ARTHROSCOPIC SURGICAL SYSTEM

K855216 is an FDA 510(k) clearance for 3M ARTHROSCOPIC SURGICAL SYSTEM, manufactured by 3M Company. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K855216 · 3M Company · Orthopedic device
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Mar 1986
Decision
64d
Days
Class 1
Risk

K855216 is an FDA 510(k) clearance for the 3M ARTHROSCOPIC SURGICAL SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on March 4, 1986 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 3M Company devices

FDA 510(k) Submission Details - K855216

510(k) Number K855216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1985
Decision Date March 04, 1986
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 33
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K855216.
ACE SCREW REMOVAL TREPHINE
K882008 · Buckman Co., Inc. · Jun 1988
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
K874044 · Medline Industries, Inc. · Oct 1987
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
K871717 · KARL STORZ Endoscopy-America, Inc. · Jun 1987
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
K854987 · Richard Wolf Medical Instruments Corp. · Feb 1986
DEXTRA PRECISION POWER SYSTEM
K853489 · Chattanooga Group, Inc. · Sep 1985
TORQUE PLUS CATALOG 30120
K833940 · Concept, Inc. · Dec 1983