Cleared Traditional

ACUMED MODULAR SHOULDER SYSTEM (K992525) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K992525 · Acu Med, Inc. · Orthopedic device
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Feb 2000
Decision
191d
Days
Class 2
Risk

K992525 is an FDA 510(k) clearance for the ACUMED MODULAR SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 191 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 Acu Med, Inc. devices

Submission Details

510(k) Number K992525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1999
Decision Date February 04, 2000
Days to Decision 191 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
69d slower than avg
Panel avg: 122d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K992525.
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K161782 · Arthrex, Inc. · Nov 2016