Cleared Traditional

K023096 - CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM

K023096 is an FDA 510(k) clearance for CONTOURED ARTICULAR PROSTHESIS (CAP) HU..., manufactured by Std Mfg., Inc.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K023096 · Std Mfg., Inc. · Orthopedic device
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Apr 2003
Decision
204d
Days
Class 2
Risk

K023096 is an FDA 510(k) clearance for the CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Std Mfg., Inc. (Stoughton, US). The FDA issued a Cleared decision on April 10, 2003 after a review of 204 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 Std Mfg., Inc. devices

FDA 510(k) Submission Details - K023096

510(k) Number K023096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2002
Decision Date April 10, 2003
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
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 63
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K023096.
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
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
K012377 · Corin USA · Mar 2002
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · Biomet Manufacturing, Inc. · Sep 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · Biomet Orthopedics, Inc. · Sep 2001