Cleared Traditional

K880265 - WEHBE ARM HOLDER

K880265 is an FDA 510(k) clearance for WEHBE ARM HOLDER, manufactured by Orthopedic Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FWZ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K880265 · Orthopedic Systems, Inc. · General & Plastic Surgery device
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Feb 1988
Decision
27d
Days
Class 1
Risk

K880265 is an FDA 510(k) clearance for the WEHBE ARM HOLDER. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - 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.

View all Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K880265

510(k) Number K880265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1988
Decision Date February 18, 1988
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

FWZ Device Classification - Class 1, General Controls

Product Code FWZ Operating Room Accessories Table Tray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 - FWZ Operating Room Accessories Table Tray

All 20
Devices cleared under the same product code (FWZ) and FDA review panel - the closest regulatory comparables to K880265.
PARK CITY SHOULDER POSITIONER
K910031 · Orthopedic Systems, Inc. · Jan 1991
SECOND ASSISTANT
K890501 · 3M Company · Feb 1989
HAND SURGERY TABLE EXTENSION
K871225 · Orthopedic Systems, Inc. · Apr 1987
LITHOTOMY HOLDERS
K870098 · Orthopedic Systems, Inc. · Feb 1987
CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION
K870101 · Orthopedic Systems, Inc. · Feb 1987
RADIOLUCENT TABLE EXTENSION
K870104 · Orthopedic Systems, Inc. · Feb 1987