Cleared Traditional

K090127 - METATARSAL DECOMPRESSION IMPLANT, MODEL 100 (FDA 510(k) Clearance)

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

K090127 · Solana Surgical, LLC · Orthopedic device
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May 2009
Decision
100d
Days
Class 2
Risk

K090127 is an FDA 510(k) clearance for the METATARSAL DECOMPRESSION IMPLANT, MODEL 100. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Solana Surgical, LLC (Oceanside, US). The FDA issued a Cleared decision on May 1, 2009 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3730 - 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 Solana Surgical, LLC devices

Submission Details

510(k) Number K090127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date May 01, 2009
Days to Decision 100 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWD Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3730
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.