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)

Biomet Knee Joint Replacement Prostheses

K-Number: K171054 · 2017-07-28

ApplicantBiomet, Inc.
Decision Date2017-07-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biomet Knee Joint Replacement Prostheses is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2017-07-28 under approval number K171054. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biomet Knee Joint Replacement Prostheses?

Biomet Knee Joint Replacement Prostheses is a medical device that received FDA 510(k) clearance on 2017-07-28. It is manufactured by Biomet, Inc.. The 510(k) number is K171054.

When was Biomet Knee Joint Replacement Prostheses approved by the FDA?

Biomet Knee Joint Replacement Prostheses received FDA 510(k) clearance on 2017-07-28, under approval number K171054.

What company makes Biomet Knee Joint Replacement Prostheses?

Biomet Knee Joint Replacement Prostheses is manufactured by Biomet, Inc..

What is the FDA product code for Biomet Knee Joint Replacement Prostheses?

The FDA product code for Biomet Knee Joint Replacement Prostheses is JWH.

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 NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING NCT05488093 Evaluation of Mobility in Subjects With Severe Knee Osteoarthritis Who Are to Undergo Total Knee Replacement 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 Biomet, Inc.

K161592Persona Partial Knee System K162424Ulna Plating System K161166StageOne Select Cement Spacer Molds for Temporary Hip Replacement K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis K161190G7 Dual Mobility System, Active Articulation System K153657Vanguard XP Knee System

View all 34 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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.

↑