Cleared Traditional

K935753 - THE GRAFTOLOGER

K935753 is an FDA 510(k) clearance for THE GRAFTOLOGER, manufactured by Neoligaments, Ltd.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K935753 · Neoligaments, Ltd. · Orthopedic device
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Apr 1994
Decision
150d
Days
Class 1
Risk

K935753 is an FDA 510(k) clearance for the THE GRAFTOLOGER. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Neoligaments, Ltd. (Leeds, GB). The FDA issued a Cleared decision on April 25, 1994 after a review of 150 days - an extended review 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: 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 Neoligaments, Ltd. devices

FDA 510(k) Submission Details - K935753

510(k) Number K935753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1993
Decision Date April 25, 1994
Days to Decision 150 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 122d · This submission: 150d
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 56
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K935753.
STRYKER TOTAL PERFORMANCE SYSTEM
K943589 · Stryker Corp. · Dec 1994
SURGICAL INSTRUMENTS AND ACCESSORIES
K942956 · Stryker Corp. · Sep 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
ACUFEX STERILE DRILLS
K931837 · Acufex Microsurgical, Inc. · Jan 1994