Cleared Traditional

K950864 - GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING) (FDA 510(k) Clearance)

K950864 · Acu Med, Inc. · Orthopedic device
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Jul 1995
Decision
154d
Days
-
Risk

K950864 is an FDA 510(k) clearance for the GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING). Classified as Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained (product code LZJ).

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on July 31, 1995 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. 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 Acu Med, Inc. devices

Submission Details

510(k) Number K950864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date July 31, 1995
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZJ Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
Device Class -