Cleared Traditional

K063578 - PROMOS MODULAR SHOULDER SYSTEM

K063578 is an FDA 510(k) clearance for PROMOS MODULAR SHOULDER SYSTEM, manufactured by Plus Orthopedics AG. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K063578 · Plus Orthopedics AG · Orthopedic device
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Mar 2007
Decision
92d
Days
Class 2
Risk

K063578 is an FDA 510(k) clearance for the PROMOS MODULAR SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Plus Orthopedics AG (Norfolk, US). The FDA issued a Cleared decision on March 2, 2007 after a review of 92 days - within the typical 510(k) review window.

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 Plus Orthopedics AG devices

FDA 510(k) Submission Details - K063578

510(k) Number K063578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2006
Decision Date March 02, 2007
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 52
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K063578.
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
K080990 · DePuy Orthopaedics, Inc. · Aug 2008
SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM
K072578 · Synthes (Usa) · Nov 2007
REUNION HA FRACTURE STEM
K070963 · Howmedica Osteonics Corp. · May 2007
AEQUALIS RESURFACING HEAD
K062661 · Tornier · Dec 2006
MODULAR REPLACEMENT ELBOW SYSTEM
K062845 · Howmedica Osteonics Corp. · Dec 2006
AEQUALIS SHOULDER SYSTEM
K063081 · Tornier · Nov 2006