Cleared Traditional

MODULAR FLEXIBLE DRILLING SYSTEM (K901165) - FDA 510(k) Clearance

Class I Orthopedic device.

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.

View all Dalton Technology, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 21
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K901165.
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ARTHREX AR-8200 SHAVER SYSTEM
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HALL MODULAR ACETABULAR REAMER SYSTEM
K902332 · Zimmer, Inc. · Jun 1990
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K895198 · Zimmer, Inc. · Sep 1989
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
K874044 · Medline Industries, Inc. · Oct 1987
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
K871717 · KARL STORZ Endoscopy-America, Inc. · Jun 1987