Cleared Traditional

K121973 - BIOPRO HEMI-EDGE TOE SYSTEM

K121973 is an FDA 510(k) clearance for BIOPRO HEMI-EDGE TOE SYSTEM, manufactured by Biopro, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K121973 · Biopro, Inc. · Orthopedic device
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Oct 2012
Decision
117d
Days
Class 2
Risk

K121973 is an FDA 510(k) clearance for the BIOPRO HEMI-EDGE TOE SYSTEM. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Biopro, Inc. (Prior Lake, US). The FDA issued a Cleared decision on October 30, 2012 after a review of 117 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 Biopro, Inc. devices

FDA 510(k) Submission Details - K121973

510(k) Number K121973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2012
Decision Date October 30, 2012
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
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 35
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K121973.
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K120029 · Solana Surgical, LLC · Feb 2012
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K092047 · Ascension Orthopedics, Inc. · Jan 2010