Cleared Traditional

K130728 - POLARSTEM STANDARD AND LATERAL FEMORAL ...

K130728 is the FDA 510(k) clearance for POLARSTEM STANDARD AND LATERAL FEMORAL ... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K130728 · Smith & Nephew, Inc. · Orthopedic device
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Oct 2013
Decision
206d
Days
Class 2
Risk

K130728 is an FDA 510(k) clearance for the POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on October 10, 2013 after a review of 206 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 K130728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2013
Decision Date October 10, 2013
Days to Decision 206 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
84d slower than avg
Panel avg: 122d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 421
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K130728.
CORIN MINIHIP STEM
K131986 · Corin USA · Dec 2013
MECTACER BIOLOX OPTION HEADS
K131518 · Medacta International · Nov 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435 · Smith & Nephew, Inc. · Oct 2013
BIOLOX(R) DELTA CERAMIC HEADS
K131684 · Biomet, Inc. · Oct 2013
MPACT DM LINER CONVERTER
K131458 · Medacta International · Oct 2013
TRINITY ACETABULAR SYSTEM
K131647 · Corin USA · Sep 2013