Cleared Traditional

K952543 - GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET (FDA 510(k) Clearance)

Class I Orthopedic device.

K952543 · Neoligaments, Ltd. · Orthopedic device
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Jun 1995
Decision
35d
Days
Class 1
Risk

K952543 is an FDA 510(k) clearance for the GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET. 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 June 22, 1995 after a review of 35 days - a notably fast clearance 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: 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 Neoligaments, Ltd. devices

Submission Details

510(k) Number K952543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1995
Decision Date June 22, 1995
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.