Cleared Traditional

K032126 - PROMOS SHOULDER

K032126 is an FDA 510(k) clearance for PROMOS SHOULDER, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K032126 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
182d
Days
Class 2
Risk

K032126 is an FDA 510(k) clearance for the PROMOS SHOULDER. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Plus Orthopedics (Round Rock, US). The FDA issued a Cleared decision on January 8, 2004 after a review of 182 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 Plus Orthopedics devices

FDA 510(k) Submission Details - K032126

510(k) Number K032126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2003
Decision Date January 08, 2004
Days to Decision 182 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
60d slower than avg
Panel avg: 122d · This submission: 182d
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 51
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K032126.
EXACTECH EQUINOXE SHOULDER STEMS
K061454 · Exactech, Inc. · Jun 2006
COPELAND EAS HUMERAL RESURFACING HEADS
K051843 · Biomet, Inc. · Sep 2005
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
K040128 · Howmedica Osteonics Corp. · Mar 2004
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
K033516 · DePuy Orthopaedics, Inc. · Dec 2003
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
K031971 · DePuy Orthopaedics, Inc. · Sep 2003
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264 · Howmedica Osteonics Corp. · Aug 2003