Cleared Traditional

K950864 - GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)

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

FDA 510(k) Submission Details - K950864

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

LZJ Device Classification - Class 0,

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

Regulatory Peers - LZJ Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained

All 9
Devices cleared under the same product code (LZJ) and FDA review panel - the closest regulatory comparables to K950864.
ARTHROSURFACE TOEMOTION
K132496 · Arthrosurface, Inc. · Feb 2014
THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
K102549 · Ascension Orthopedics, Inc. · Dec 2010
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
K072251 · Merete Medical GmbH · May 2008
TOTAL TOE SYSTEM II
K941650 · Biomet, Inc. · Dec 1994
KINETIK GREAT TOE SYSTEM
K924724 · Kinetikos Medical, Inc. · Jan 1994
OSTEOMED GREAT TOE SYSTEM
K922211 · Osteomed Corp. · Nov 1993