Cleared Traditional

K120029 - HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET

K120029 is an FDA 510(k) clearance for HEMI PHALANGEAL IMPLANT SURGICAL INSTRU..., manufactured by Solana Surgical, LLC. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K120029 · Solana Surgical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
33d
Days
Class 2
Risk

K120029 is an FDA 510(k) clearance for the HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Solana Surgical, LLC (Memphis, US). The FDA issued a Cleared decision on February 6, 2012 after a review of 33 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K120029

510(k) Number K120029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2012
Decision Date February 06, 2012
Days to Decision 33 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 122d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KWD Prosthesis, Toe, Hemi-, Phalangeal

All 42
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K120029.
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K092047 · Ascension Orthopedics, Inc. · Jan 2010
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K090127 · Solana Surgical, LLC · May 2009