Cleared Traditional

K870126 - FEMUR WRENCH

K870126 is an FDA 510(k) clearance for FEMUR WRENCH, manufactured by Orthopedic Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEG cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K870126 · Orthopedic Systems, Inc. · General & Plastic Surgery device
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Feb 1987
Decision
22d
Days
Class 1
Risk

K870126 is an FDA 510(k) clearance for the FEMUR WRENCH. Classified as Elevator, Surgical, General & Plastic Surgery (product code GEG), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on February 3, 1987 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 - K870126

510(k) Number K870126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1987
Decision Date February 03, 1987
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

GEG Device Classification - Class 1, General Controls

Product Code GEG Elevator, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GEG Elevator, Surgical, General & Plastic Surgery

All 9
Devices cleared under the same product code (GEG) and FDA review panel - the closest regulatory comparables to K870126.
SURGICAL ELEVATOR
K890253 · Kinetic Medical Products · Jan 1989
1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS
K872491 · Micro-Aire Surgical Instruments, Inc. · Jul 1987
ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS
K870781 · Buckman Co., Inc. · Mar 1987
H.R. JAKOBI SURG. INSTRUMENTS 40/41
K834176 · Imm Enterprises , Ltd. · Jan 1984
HARRINGTON SPINAL ELEVATOR
K781449 · Orthopedic Equipment Co., Inc. · Sep 1978