K922211 - OSTEOMED GREAT TOE SYSTEM (FDA 510(k) Clearance)

K922211 is an FDA 510(k) clearance for the OSTEOMED GREAT TOE SYSTEM. Classified as Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained (product code LZJ).

Submitted by Osteomed Corp. (Glendale, US). The FDA issued a Cleared decision on November 9, 1993 after a review of 546 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

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