Cleared Traditional

K121714 - SMITH & NEPHEW

K121714 is the FDA 510(k) clearance for SMITH & NEPHEW by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HSD) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K121714 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
88d
Days
Class 2
Risk

K121714 is an FDA 510(k) clearance for the SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 7, 2012 after a review of 88 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K121714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2012
Decision Date September 07, 2012
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 48
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K121714.
Arthrex Univers Revers CA Heads and Adapters
K151527 · Arthrex, Inc. · Apr 2016
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298 · Exactech, Inc. · Nov 2013
ARTHREX UNIVERS II CA HEADS
K130675 · Arthrex, Inc. · Oct 2013
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
K112900 · Lima Corporate S.P.A. · Jun 2012
DEPUY GLOBAL AP CTA HUMERAL HEAD
K082715 · DePuy Orthopaedics, Inc. · Dec 2008
DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
K080990 · DePuy Orthopaedics, Inc. · Aug 2008