Cleared Traditional

K853762 - ISOMETRIC ACL DRILL GUIDE

K853762 is an FDA 510(k) clearance for ISOMETRIC ACL DRILL GUIDE, manufactured by Orthopedic Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEY cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K853762 · Orthopedic Systems, Inc. · General & Plastic Surgery device
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Oct 1985
Decision
28d
Days
Class 1
Risk

K853762 is an FDA 510(k) clearance for the ISOMETRIC ACL DRILL GUIDE. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on October 7, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery device 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 Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K853762

510(k) Number K853762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date October 07, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

GEY Device Classification - Class 1, General Controls

Product Code GEY Motor, Surgical Instrument, Ac-powered
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 - GEY Motor, Surgical Instrument, Ac-powered

All 17
Devices cleared under the same product code (GEY) and FDA review panel - the closest regulatory comparables to K853762.
MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS
K900033 · Micro-Aire Surgical Instruments, Inc. · Feb 1990
THE DEXTRA PRECISION POWER UNIT
K853778 · Storz Instrument Co. · Nov 1985
DRILLING TEMPLATE
K853761 · Orthopedic Systems, Inc. · Oct 1985
MULTIPLE OUTLET MANIFOLD
K850389 · The Anspach Effort, Inc. · Mar 1985
RICHARDS INTRA-ARTICULAR SHAVER MOTOR
K842475 · Richards Medical Co., Inc. · Sep 1984
ELECTRO SURGERY SYSTEM
K841165 · Micro-Aire Surgical Instruments, Inc. · Jun 1984