Cleared Traditional

K942956 - SURGICAL INSTRUMENTS AND ACCESSORIES

K942956 is an FDA 510(k) clearance for SURGICAL INSTRUMENTS AND ACCESSORIES, manufactured by Stryker Corp.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K942956 · Stryker Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
92d
Days
Class 1
Risk

K942956 is an FDA 510(k) clearance for the SURGICAL INSTRUMENTS AND ACCESSORIES. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on September 23, 1994 after a review of 92 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 Stryker Corp. devices

FDA 510(k) Submission Details - K942956

510(k) Number K942956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date September 23, 1994
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 52
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K942956.
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
TOTAL KNEE KIT
K932918 · Biodynamic Technologies, Inc. · Sep 1994
INTERMEDICS ORTHOPEDICS DRILL BITS
K931734 · Intermedics Orthopedics · Feb 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · Arthrex, Inc. · Jan 1994