Cleared Traditional

K162719 - iTotal® Hip Replacement System

K162719 is an FDA 510(k) clearance for iTotal Hip Replacement System, manufactured by Conformis, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 258-day FDA review.

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

FDA 510(k) Submission Details - K162719

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
Combination Product No
PCCP Authorized No
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.

LPH Device Classification - Class 2, Special Controls

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 541
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K162719.
Klassic HD® Hip System
K171962 · Total Joint Othopedics, Inc. · Jul 2017
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K162957 · United Orthopedic Corporation · Jul 2017
PROCOTYL® PRIME Acetabular Cup System
K170444 · Microport Orthopedics, Inc. · Jun 2017
UTF Stem, reduced, #0, #00
K163193 · United Orthopedic Corporation · Jun 2017
Bencox M Stem Lateralized & Bencox Mirabo Cup System
K162127 · Corentec Co., Ltd. · Dec 2016
Klassic HD Hip System
K161073 · Total Joint Othopedics, Inc. · Oct 2016