Cleared Traditional

K061862 - AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM

K061862 is an FDA 510(k) clearance for AXIOM ORTHOPAEDICS SHOULDER RESURFACING..., manufactured by Axiom Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K061862 · Axiom Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
59d
Days
Class 2
Risk

K061862 is an FDA 510(k) clearance for the AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Axiom Orthopaedics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 28, 2006 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Axiom Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K061862

510(k) Number K061862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2006
Decision Date August 28, 2006
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 59
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K061862.
MODULAR REPLACEMENT ELBOW SYSTEM
K062845 · Howmedica Osteonics Corp. · Dec 2006
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ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
K062861 · Ascension Orthopedics, Inc. · Oct 2006
SOLAR PUREFIX HA SHOULDER
K061677 · Howmedica Osteonics Corp. · Jul 2006
EXACTECH EQUINOXE SHOULDER STEMS
K061454 · Exactech, Inc. · Jun 2006
COPELAND EAS HUMERAL RESURFACING HEADS
K051843 · Biomet, Inc. · Sep 2005