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FDA 510(k)

EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt

K-Number: K163497 · 2017-03-02

ApplicantEncore Medical L.P.
Decision Date2017-03-02
Product CodeKWZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt is a medical device manufactured by Encore Medical L.P.. It received FDA 510(k) clearance on 2017-03-02 under approval number K163497. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt?

EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by Encore Medical L.P.. The 510(k) number is K163497.

When was EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt approved by the FDA?

EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt received FDA 510(k) clearance on 2017-03-02, under approval number K163497.

What company makes EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt?

EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt is manufactured by Encore Medical L.P..

What is the FDA product code for EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt?

The FDA product code for EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt is KWZ.

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Related PubMed Literature

PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 39744726 Regulatory gaps in India's medical device framework: The case of Johnson and Johnson's faulty hip implants. World journal of orthopedics (2024)

Other Devices by Encore Medical L.P.

K162024AltiVate Anatomic Shoulder System K161610EXPRT Revision Hip System K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) K160342EMPOWR PS Knee System K173073AltiVate Anatomic to Reverse Conversion Module K172651FMP Extended Liners

View all 31 devices →

Related Devices (Code: KWZ)

K161610EXPRT Revision Hip SystemEncore Medical L.P. K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc. K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC K241461Mpact Constrained LinerMedacta International S.A.

Official Source

View on FDA Database →

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

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