Cleared Traditional

K012377 - OXFORD MODULAR SHOULDER PROSTHESIS

K012377 is an FDA 510(k) clearance for OXFORD MODULAR SHOULDER PROSTHESIS, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K012377 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
228d
Days
Class 2
Risk

K012377 is an FDA 510(k) clearance for the OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on March 11, 2002 after a review of 228 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 Corin USA devices

FDA 510(k) Submission Details - K012377

510(k) Number K012377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date March 11, 2002
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
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 54
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K012377.
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
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · Biomet Manufacturing, Inc. · Sep 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · Biomet Orthopedics, Inc. · Sep 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942 · Tornier · Jul 2001