Cleared Traditional

K162719 - iTotal® Hip Replacement System (FDA 510(k) Clearance)

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

K162719 · Conformis, Inc. · Orthopedic device
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Jun 2017
Decision
258d
Days
Class 2
Risk

K162719 is an FDA 510(k) clearance for the iTotal® Hip Replacement System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Conformis, Inc. (Bedford, US). The FDA issued a Cleared decision on June 14, 2017 after a review of 258 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 Conformis, Inc. devices

Submission Details

510(k) Number K162719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2016
Decision Date June 14, 2017
Days to Decision 258 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
136d slower than avg
Panel avg: 122d · This submission: 258d
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 558
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