Cleared Traditional

SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS (K971715) - FDA 510(k) Clearance

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

K971715 · Sulzer Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
90d
Days
Class 2
Risk

K971715 is an FDA 510(k) clearance for the SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on August 7, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 Sulzer Orthopedics, Inc. devices

Submission Details

510(k) Number K971715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1997
Decision Date August 07, 1997
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 92
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K971715.
OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
K990598 · Howmedica Osteonics Corp. · Mar 1999
DEPUY GLOBAL SHOULDER GLENOID
K981487 · DePuy Orthopaedics, Inc. · Jul 1998
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD
K974044 · DePuy Orthopaedics, Inc. · Jan 1998
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
K962082 · Osteonics Corp. · Aug 1996
OSTEONICS N2/VAC PACKAGING PROCESS
K955944 · Osteonics Corp. · Apr 1996
OSTEONICS SHOULDER HUMERAL COMPONENTS
K955731 · Osteonics Corp. · Mar 1996