Cleared Special

K172501 - iNSitu Total Hip System

K172501 is the FDA 510(k) clearance for iNSitu Total Hip System by Theken Companies, LLC. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 34-day FDA review.

K172501 · Theken Companies, LLC · Orthopedic device
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Sep 2017
Decision
34d
Days
Class 2
Risk

K172501 is an FDA 510(k) clearance for the iNSitu Total Hip System. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Theken Companies, LLC (Akron, US). The FDA issued a Cleared decision on September 21, 2017 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Theken Companies, LLC devices

Submission Details

510(k) Number K172501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2017
Decision Date September 21, 2017
Days to Decision 34 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

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 429
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K172501.
Smith & Nephew, Inc. REDAPT Augments
K171073 · Smith & Nephew, Inc. · Nov 2017
UTS Stem
K172251 · United Orthopedic Corporation · Oct 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · Smith & Nephew, Inc. · Oct 2017
U2 Femoral Head
K162957 · United Orthopedic Corporation · Jul 2017
PROCOTYL® PRIME Acetabular Cup System
K170444 · Microport Orthopedics, Inc. · Jun 2017
iTotal® Hip Replacement System
K162719 · Conformis, Inc. · Jun 2017