Cleared Traditional

INFINITY SHOULDER SYSTEM (K943908) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943908 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
292d
Days
Class 2
Risk

K943908 is an FDA 510(k) clearance for the INFINITY SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 292 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K943908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1994
Decision Date May 30, 1995
Days to Decision 292 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
170d slower than avg
Panel avg: 122d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 32
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K943908.
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · Howmedica Osteonics Corp. · Jul 2000
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · Biomet, Inc. · Apr 1997
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
K954559 · Howmedica Corp. · Jul 1996
GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL
K911686 · Depuy, Inc. · Jul 1991
EXACTECH HUMERAL SHOULDER PROSTHESIS
K905577 · Exactech, Inc. · Mar 1991
TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO
K905580 · Exactech, Inc. · Mar 1991