Cleared Traditional

K953071 - STRYKER COMMAND2 OFFICE CONSOLE

K953071 is an FDA 510(k) clearance for STRYKER COMMAND2 OFFICE CONSOLE, manufactured by Stryker Instruments. The device is a Class 1 General & Plastic Surgery device with product code JEA cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K953071 · Stryker Instruments · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
39d
Days
Class 1
Risk

K953071 is an FDA 510(k) clearance for the STRYKER COMMAND2 OFFICE CONSOLE. Classified as Table, Surgical With Orthopedic Accessories, Ac-powered (product code JEA), Class I - General Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on August 8, 1995 after a review of 39 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - the FDA general and plastic surgery device 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.

FDA 510(k) Submission Details - K953071

510(k) Number K953071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1995
Decision Date August 08, 1995
Days to Decision 39 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

JEA Device Classification - Class 1, General Controls

Product Code JEA Table, Surgical With Orthopedic Accessories, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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 - JEA Table, Surgical With Orthopedic Accessories, Ac-powered

All 9
Devices cleared under the same product code (JEA) and FDA review panel - the closest regulatory comparables to K953071.
MEND APC
K924094 · Mend Technologies, Inc. · Mar 1993
JACKSON MULTIPURPOSE OPERATING TABLE
K910736 · Orthopedic Systems, Inc. · May 1991
ARTHROBOT(TM) WRIST HOLDER ACCESSORY
K911522 · Andronic Devices, Ltd. · Apr 1991
SKYTRON MODEL 1100 AND MODEL 142
K900290 · Skytron, Div. the Kmw Group, Inc. · Feb 1990
DMI 250 SERIES POWER SURGERY TABLE
K894789 · M.D. Intl., Inc. · Aug 1989
OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)
K881060 · Orthopedic Systems, Inc. · Mar 1988
K953071 · STRYKER COMMAND2 OFFICE CONSOLE
Download PDF FDA Summary Stryker Instruments