Cleared Traditional

K072817 - ECHELON TITANIUM HIP SYSTEM

K072817 is the FDA 510(k) clearance for ECHELON TITANIUM HIP SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K072817 · Smith & Nephew, Inc. · Orthopedic device
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May 2008
Decision
226d
Days
Class 2
Risk

K072817 is an FDA 510(k) clearance for the ECHELON TITANIUM HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on May 15, 2008 after a review of 226 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 K072817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2007
Decision Date May 15, 2008
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 442
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K072817.
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566 · Smith & Nephew, Inc. · Aug 2008
REVELATION HIP STEM, MODELS, 427-01, 427-02
K081679 · Encore Medical, L.P. · Aug 2008
TRITANIUM ACETABULAR SHELL SYSTEM
K081171 · Howmedica Osteonics Corp. · Jul 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625 · Smith & Nephew, Inc. · May 2008
SMITH & NEPHEW MIS HIP STEM
K072417 · Smith & Nephew, Inc. · Jan 2008
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
K072888 · Encore Medical, L.P. · Jan 2008