Cleared Traditional

K960852 - HALL MODULAR ACETABULAR REAMER SYSTEM

K960852 is the FDA 510(k) clearance for HALL MODULAR ACETABULAR REAMER SYSTEM by Linvatec Corp.. It is a Class 1 Orthopedic device (product code HWE) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K960852 · Linvatec Corp. · Orthopedic device
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Mar 1996
Decision
19d
Days
Class 1
Risk

K960852 is an FDA 510(k) clearance for the HALL MODULAR ACETABULAR REAMER SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on March 20, 1996 after a review of 19 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Linvatec Corp. devices

Submission Details

510(k) Number K960852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1996
Decision Date March 20, 1996
Days to Decision 19 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 122d · This submission: 19d
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 31
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K960852.
POWERCUT GOLD SURGICAL SYSTEM
K962022 · Baxter Healthcare Corp · Aug 1996
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
K961970 · Stryker Corp. · Jul 1996
EXACTECH STERILE MODULAR DRILL BIT
K960720 · Exactech, Inc. · Apr 1996
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
K953968 · Aesculap, Inc. · Feb 1996
3M MINI-DRIVER ELECTRIC SYSTEM
K955098 · 3M Company · Jan 1996
STRYKER TOTAL PERFORMANCE SYSTEM
K943589 · Stryker Corp. · Dec 1994