Cleared Traditional

K920667 - GREAT TOE IMPLANT

K920667 · Acu Med, Inc. · Orthopedic device
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Jun 1992
Decision
127d
Days
-
Risk

K920667 is an FDA 510(k) clearance for the GREAT TOE IMPLANT. 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 June 19, 1992 after a review of 127 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K920667

510(k) Number K920667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1992
Decision Date June 19, 1992
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 10
Devices cleared under the same product code (LZJ) and FDA review panel - the closest regulatory comparables to K920667.
KINETIK GREAT TOE SYSTEM
K924724 · Kinetikos Medical, Inc. · Jan 1994
OSTEOMED GREAT TOE SYSTEM
K922211 · Osteomed Corp. · Nov 1993
TOTAL TOE SYSTEM
K920446 · Biomet, Inc. · Mar 1993
ANATOMIC TOE SYSTEM
K911552 · Orthopaedic Biosystems · Jun 1991
KOENIG TOTAL TOE IMPLANT
K884561 · Dow Corning Wright · Jan 1989
K920667 · GREAT TOE IMPLANT
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