Cleared Traditional

K922292 - LUNDEEN SUBTALAR PEG IMPLANT

K922292 is an FDA 510(k) clearance for LUNDEEN SUBTALAR PEG IMPLANT, manufactured by Sgarlato Laboratories, Inc.. The device is a Class 2 Orthopedic device with product code MJW cleared through the Traditional 510(k) pathway after a 161-day FDA review.

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

FDA 510(k) Submission Details - K922292

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.

MJW Device Classification - Class 2, Special Controls

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.