Cleared Traditional

K992525 - ACUMED MODULAR SHOULDER SYSTEM

K992525 is an FDA 510(k) clearance for ACUMED MODULAR SHOULDER SYSTEM, manufactured by Acu Med, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K992525

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.

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 62
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
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
K992394 · Endotec, Inc. · Oct 1999
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202 · Howmedica, Inc. · Feb 1999
OTI MODULAR SHOULDER SYSTEM
K982886 · Osteoimplant Technology, Inc. · Oct 1998