Cleared Traditional

K161184 - iNSitu Total Hip System

K161184 is an FDA 510(k) clearance for iNSitu Total Hip System, manufactured by Theken Companies, LLC. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K161184 · Theken Companies, LLC · Orthopedic device
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Oct 2016
Decision
170d
Days
Class 2
Risk

K161184 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 October 14, 2016 after a review of 170 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 Theken Companies, LLC devices

FDA 510(k) Submission Details - K161184

510(k) Number K161184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2016
Decision Date October 14, 2016
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
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 Consultant

Musculosketal Clinical Regulatory Advisors, LLC (Mcra)
Hollace Saas Rhodes

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 534
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K161184.
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Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
K161569 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Oct 2016
The Progressive Orthopaedic Total Hip System
K151424 · The Progressive Orthopaedic Company, LLC · Jul 2016
G7 Dual Mobility System, Active Articulation System
K161190 · Biomet, Inc. · May 2016