Cleared Traditional

K010869 - EPOCA CUSTOM OFFSET SHOULDER SYSTEM

K010869 is an FDA 510(k) clearance for EPOCA CUSTOM OFFSET SHOULDER SYSTEM, manufactured by Argomedical AG. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K010869 · Argomedical AG · Orthopedic device
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Oct 2001
Decision
202d
Days
Class 2
Risk

K010869 is an FDA 510(k) clearance for the EPOCA CUSTOM OFFSET SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Argomedical AG (Pittsburgh, US). The FDA issued a Cleared decision on October 11, 2001 after a review of 202 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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 Argomedical AG devices

FDA 510(k) Submission Details - K010869

510(k) Number K010869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2001
Decision Date October 11, 2001
Days to Decision 202 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
80d slower than avg
Panel avg: 122d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 67
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K010869.
SHORT AND LONG SOFT TISSUE ATTACHMENT
K022079 · Biomet, Inc. · Sep 2002
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
K020045 · Biomet Orthopedics, Inc. · Jan 2002
EPOCA CODR STEM AND HEAD
K014049 · Stelkast Company · Jan 2002
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · Biomet, Inc. · Oct 2000
BIPOLAR SHOULDER PROSTHESIS
K991585 · Biomet, Inc. · Aug 1999
GRIT BLASTED HUMERAL STEM
K991603 · Encore Orthopedics, Inc. · Jun 1999