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FDA 510(k)

iNSitu Total Hip System

K-Number: K191936 · 2019-08-20

ApplicantThecken Companies, LLC
Decision Date2019-08-20
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

iNSitu Total Hip System is a medical device manufactured by Thecken Companies, LLC. It received FDA 510(k) clearance on 2019-08-20 under approval number K191936. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iNSitu Total Hip System?

iNSitu Total Hip System is a medical device that received FDA 510(k) clearance on 2019-08-20. It is manufactured by Thecken Companies, LLC. The 510(k) number is K191936.

When was iNSitu Total Hip System approved by the FDA?

iNSitu Total Hip System received FDA 510(k) clearance on 2019-08-20, under approval number K191936.

What company makes iNSitu Total Hip System?

iNSitu Total Hip System is manufactured by Thecken Companies, LLC.

What is the FDA product code for iNSitu Total Hip System?

The FDA product code for iNSitu Total Hip System is LPH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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