Cleared Traditional

K911552 - ANATOMIC TOE SYSTEM (FDA 510(k) Clearance)

K911552 · Orthopaedic Biosystems · Orthopedic device
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Jun 1991
Decision
81d
Days
-
Risk

K911552 is an FDA 510(k) clearance for the ANATOMIC TOE SYSTEM. Classified as Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained (product code LZJ).

Submitted by Orthopaedic Biosystems (Carlsbad, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 81 days - a notably fast clearance 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: 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 Orthopaedic Biosystems devices

Submission Details

510(k) Number K911552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1991
Decision Date June 28, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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