Cleared Traditional

K905027 - CUP OUT

K905027 is an FDA 510(k) clearance for CUP OUT, manufactured by Anspach Mfg., Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K905027 · Anspach Mfg., Inc. · Orthopedic device
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Feb 1991
Decision
90d
Days
Class 1
Risk

K905027 is an FDA 510(k) clearance for the CUP OUT. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Anspach Mfg., Inc. (Lake Park, US). The FDA issued a Cleared decision on February 5, 1991 after a review of 90 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 Anspach Mfg., Inc. devices

FDA 510(k) Submission Details - K905027

510(k) Number K905027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date February 05, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & 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 - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 36
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K905027.
ARTHREX CIRCULAR HARVESTING SAW
K941681 · Arthrex, Inc. · Aug 1994
PNEUMATIC WIRE TENSIONER
K934431 · Smith & Nephew Richards, Inc. · Jan 1994
JOHNSON AND JOHNSON POWER SYSTEM
K913629 · Johnson & Johnson Orthopaedics, Inc. · Nov 1991
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
K904949 · Micro-Aire Surgical Instruments, Inc. · Nov 1990
OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
K903713 · Micro-Aire Surgical Instruments, Inc. · Sep 1990
THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM
K901455 · Kirschner Medical Corp. · May 1990