Cleared Traditional

K994350 - NEER III TOTAL SHOULDER SYSTEM

K994350 is the FDA 510(k) clearance for NEER III TOTAL SHOULDER SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code KWS) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K994350 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
152d
Days
Class 2
Risk

K994350 is an FDA 510(k) clearance for the NEER III TOTAL SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on May 23, 2000 after a review of 152 days - an extended review cycle.

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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K994350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date May 23, 2000
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
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 152
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K994350.
WMT MODULAR SHOULDER SYSTEM
K001706 · Wrightmedicaltechnologyinc · Aug 2000
AEQUALIS UNIVERSAL SHOULDER GLENOID
K994393 · Tornier · Jun 2000
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
K001046 · Biopro, Inc. · Jun 2000
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
K000575 · DePuy Orthopaedics, Inc. · Mar 2000
AEQUALIS SHOULDER FRACTURE SYSTEM
K994392 · Tornier · Mar 2000
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
K992899 · Biomet, Inc. · Oct 1999