iNSitu Total Hip System

FDA 510(k) K161184 · Theken Companies, LLC

Substantially Equivalent

510(k) numberK161184

Submission

Device name
iNSitu Total Hip System
Applicant
Theken Companies, LLC
Akron, OH, US
Received
April 27, 2016
Decision date
October 14, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3358
Specialty
Orthopedic
Implant
Yes

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K253630Mpact 3D Metal FoamLPH · Traditional Medacta International S.A.08/28/2026SE
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K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional Howmedica Osteonics Corp., Dba Stryker…07/10/2026SE
K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional Nextstep Arthopedix, LLC06/05/2026SE
K251270Taperloc® Complete Hip StemLPH · Traditional Biomet, Inc.05/19/2026SE
K252623G7® Revision Acetabular SystemLPH · Traditional Zimmer, Inc.02/04/2026SE
K251043Mpact 3D Metal Implants Extension – DMLS TechnologyLPH · Traditional Medacta International S.A.01/28/2026SE
K252067Velora Acetabular SystemLPH · Traditional Restor3D, Inc.12/05/2025SE
K252846TaperSet™ Hip SystemLPH · Special Shalby Advanced Technologies, Inc. Dba Consensus…11/20/2025SE
K251833EMPOWR Acetabular® Liner ExtensionLPH · Traditional Encore Medical L.P.11/12/2025SE

More from Encore Medical L.P.

510(k)DeviceDecision
K220336Mg-PSZ Ceramic Femoral HeadLPH · Special 09/30/2022SE
K191297iNSitu Bipolar Hip SystemKWY · Traditional 09/17/2019SE
K192071iNSitu Total Hip SystemLPH · Special 08/30/2019SE
K172501iNSitu Total Hip SystemLPH · Special 09/21/2017SE

Questions and answers

When was iNSitu Total Hip System cleared by the FDA?

iNSitu Total Hip System (K161184) received a 510(k) decision of Substantially Equivalent on October 14, 2016, 170 days after the submission was received.

What is the product code of K161184?

The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.