Cleared Traditional

K901165 - MODULAR FLEXIBLE DRILLING SYSTEM

K901165 is an FDA 510(k) clearance for MODULAR FLEXIBLE DRILLING SYSTEM, manufactured by Dalton Technology, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K901165 · Dalton Technology, Inc. · Orthopedic device
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Jun 1990
Decision
92d
Days
Class 1
Risk

K901165 is an FDA 510(k) clearance for the MODULAR FLEXIBLE DRILLING SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Dalton Technology, Inc. (Glendale, US). The FDA issued a Cleared decision on June 13, 1990 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K901165

510(k) Number K901165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1990
Decision Date June 13, 1990
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 70
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K901165.
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
K903650 · Micro-Aire Surgical Instruments, Inc. · Sep 1990
CORING NEEDLE (TREPHINE, ORTHOPEDIC)
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HALL MODULAR ACETABULAR REAMER SYSTEM
K902332 · Zimmer, Inc. · Jun 1990
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K895198 · Zimmer, Inc. · Sep 1989
ACE SCREW REMOVAL TREPHINE
K882008 · Buckman Co., Inc. · Jun 1988
PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM
K880150 · Dyonics, Inc. · Mar 1988
K901165 · MODULAR FLEXIBLE DRILLING SYSTEM
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