Cleared Traditional

K992525 - ACUMED MODULAR SHOULDER SYSTEM

K992525 is the FDA 510(k) clearance for ACUMED MODULAR SHOULDER SYSTEM by Acu Med, Inc.. It is a Class 2 Orthopedic device (product code HSD) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

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
Combination Product No
PCCP Authorized No
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 47
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K992525.
COPELAND RESURFACING HEADS
K003044 · Biomet, Inc. · Dec 2000
ISS OFFSET HEADS
K003428 · Biomet, Inc. · Nov 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · Howmedica Osteonics Corp. · Jul 2000
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202 · Howmedica, Inc. · Feb 1999
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · Biomet, Inc. · Apr 1997
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962289 · Intermedics Orthopedics · Aug 1996