Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Zimmer Hip Joint Replacement

K-Number: K200112 · 2020-04-10

ApplicantZimmer GmbH
Decision Date2020-04-10
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Hip Joint Replacement is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2020-04-10 under approval number K200112. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Hip Joint Replacement?

Zimmer Hip Joint Replacement is a medical device that received FDA 510(k) clearance on 2020-04-10. It is manufactured by Zimmer GmbH. The 510(k) number is K200112.

When was Zimmer Hip Joint Replacement approved by the FDA?

Zimmer Hip Joint Replacement received FDA 510(k) clearance on 2020-04-10, under approval number K200112.

What company makes Zimmer Hip Joint Replacement?

Zimmer Hip Joint Replacement is manufactured by Zimmer GmbH.

What is the FDA product code for Zimmer Hip Joint Replacement?

The FDA product code for Zimmer Hip Joint Replacement is LZO.

Related Clinical Trials

NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT06833372 Shock Waves in Knee Arthritis RECRUITING NCT07569549 Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy NOT_YET_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT05488093 Evaluation of Mobility in Subjects With Severe Knee Osteoarthritis Who Are to Undergo Total Knee Replacement RECRUITING NCT07502040 Impact of Exercise Access on Physio Outcomes Post Knee Replacement NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

Other Devices by Zimmer GmbH

K161620Anatomical Shoulder Domelock Dome centric K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System K171858Sidus Stem-Free Shoulder K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System K170072Fitmore® Hip Stem

View all 19 devices →

Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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.

↑