Cleared Traditional

K193122 - Biocore9 Humeral Resurfacing System

K193122 is an FDA 510(k) clearance for Biocore9 Humeral Resurfacing System, manufactured by Biocore9, LLC. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K193122 · Biocore9, LLC · Orthopedic device
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May 2020
Decision
185d
Days
Class 2
Risk

K193122 is an FDA 510(k) clearance for the Biocore9 Humeral Resurfacing System. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Biocore9, LLC (Whippany, US). The FDA issued a Cleared decision on May 15, 2020 after a review of 185 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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 Biocore9, LLC devices

FDA 510(k) Submission Details - K193122

510(k) Number K193122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2019
Decision Date May 15, 2020
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSD Device Classification - Class 2, Special Controls

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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 - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 56
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K193122.
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K161782 · Arthrex, Inc. · Nov 2016
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K161620 · Zimmer GmbH · Nov 2016