Cleared Traditional

K864881 - ARTHROSCOPIC ANKLE HOLDER

K864881 is an FDA 510(k) clearance for ARTHROSCOPIC ANKLE 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 17-day FDA review.

K864881 · Orthopedic Systems, Inc. · General & Plastic Surgery device
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Dec 1986
Decision
17d
Days
Class 1
Risk

K864881 is an FDA 510(k) clearance for the ARTHROSCOPIC ANKLE 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 December 29, 1986 after a review of 17 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 - K864881

510(k) Number K864881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1986
Decision Date December 29, 1986
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 K864881.
CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION
K870101 · Orthopedic Systems, Inc. · Feb 1987
RADIOLUCENT TABLE EXTENSION
K870104 · Orthopedic Systems, Inc. · Feb 1987
COLLINS POSITIONING DEVICE
K864880 · Orthopedic Systems, Inc. · Dec 1986
BASILDON-GARDNER SPINAL FRAME
K842700 · Downs Surgical , Ltd. · Sep 1984
ULNAR NERVE PROTECTOR
K840421 · Devon Industries, Inc. · Mar 1984
DEVON HEAD REST
K840422 · Devon Industries, Inc. · Mar 1984