Cleared Traditional

HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM (K895198) - FDA 510(k) Clearance

Class I Orthopedic device.

K895198 · Zimmer, Inc. · Orthopedic device
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Sep 1989
Decision
35d
Days
Class 1
Risk

K895198 is an FDA 510(k) clearance for the HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Zimmer, Inc. (`Anta Barbara, US). The FDA issued a Cleared decision on September 15, 1989 after a review of 35 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 Zimmer, Inc. devices

Submission Details

510(k) Number K895198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1989
Decision Date September 15, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
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 17
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K895198.
3M MINI-DRIVER ELECTRIC SYSTEM
K955098 · 3M Company · Jan 1996
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · Arthrex, Inc. · Jan 1994
HALL MODULAR ACETABULAR REAMER SYSTEM
K902332 · Zimmer, Inc. · Jun 1990
INTRA-ARTICULAR ARTHROSCOPIC SHAVER
K874044 · Medline Industries, Inc. · Oct 1987
MODEL 28200C MICRO-ARTHROPLASTY SYSTEM
K871717 · KARL STORZ Endoscopy-America, Inc. · Jun 1987
3M ARTHROSCOPIC SURGICAL SYSTEM
K855216 · 3M Company · Mar 1986