Cleared Traditional

K950013 - CONSENSUS(TM) ORTHOPEDIC DRILL BIT

K950013 is an FDA 510(k) clearance for CONSENSUS(TM) ORTHOPEDIC DRILL BIT, 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 122-day FDA review.

K950013 · U.S. Medical Products, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
122d
Days
Class 1
Risk

K950013 is an FDA 510(k) clearance for the CONSENSUS(TM) ORTHOPEDIC DRILL BIT. 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 May 5, 1995 after a review of 122 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 - K950013

510(k) Number K950013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1995
Decision Date May 05, 1995
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
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 K950013.
HALL MODULAR ACETABULAR REAMER SYSTEM
K960852 · Linvatec Corp. · Mar 1996
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
K953968 · Aesculap, Inc. · Feb 1996
3M MINI-DRIVER ELECTRIC SYSTEM
K955098 · 3M Company · Jan 1996
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
CONSENUS HIP SYSTEM -- ACETABULAR REAMER
K945186 · U.S. Medical Products, Inc. · Jan 1995