Cleared Traditional

K922292 - LUNDEEN SUBTALAR PEG IMPLANT (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K922292 · Sgarlato Laboratories, Inc. · Orthopedic device
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Oct 1992
Decision
161d
Days
Class 2
Risk

K922292 is an FDA 510(k) clearance for the LUNDEEN SUBTALAR PEG IMPLANT. Classified as Prosthesis, Subtalar, Plug, Polymer (product code MJW), Class II - Special Controls.

Submitted by Sgarlato Laboratories, Inc. (San Jose, US). The FDA issued a Cleared decision on October 23, 1992 after a review of 161 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. 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 Sgarlato Laboratories, Inc. devices

Submission Details

510(k) Number K922292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date October 23, 1992
Days to Decision 161 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
39d slower than avg
Panel avg: 122d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJW Prosthesis, Subtalar, Plug, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.