Cleared Traditional

K945186 - CONSENUS HIP SYSTEM -- ACETABULAR REAMER

K945186 is an FDA 510(k) clearance for CONSENUS HIP SYSTEM -- ACETABULAR REAMER, manufactured by U.S. Medical Products, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K945186 · U.S. Medical Products, Inc. · Orthopedic device
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Jan 1995
Decision
95d
Days
Class 1
Risk

K945186 is an FDA 510(k) clearance for the CONSENUS HIP SYSTEM -- ACETABULAR REAMER. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by U.S. Medical Products, Inc. (Austin, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 95 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 U.S. Medical Products, Inc. devices

FDA 510(k) Submission Details - K945186

510(k) Number K945186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1994
Decision Date January 27, 1995
Days to Decision 95 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 122d · This submission: 95d
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 40
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K945186.
CONSENSUS(TM) ORTHOPEDIC DRILL BIT
K950013 · U.S. Medical Products, Inc. · May 1995
CONSENSUS(TM) PATELLA REAMER
K946197 · U.S. Medical Products, Inc. · Apr 1995
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER
K944946 · U.S. Medical Products, Inc. · Feb 1995
CONSENSUS HIP SYSTEM -- CALCAR PLANER
K945189 · U.S. Medical Products, Inc. · Jan 1995
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER
K945208 · U.S. Medical Products, Inc. · Jan 1995
STRYKER TOTAL PERFORMANCE SYSTEM
K943589 · Stryker Corp. · Dec 1994