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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 the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2017-07-28 under 510(k) 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. The listed applicant is Biomet, Inc.. The 510(k) number is K171054.

When did Biomet Knee Joint Replacement Prostheses receive FDA 510(k) clearance?

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

Who is the listed applicant for Biomet Knee Joint Replacement Prostheses?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05391828Persona MC vs PS RCT With ROSARECRUITINGNCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITINGNCT02440672JOURNEY™ II CR Total Knee SystemACTIVE_NOT_RECRUITINGNCT03895489Effectiveness of the Journey Total Knee Arthroplasty Versus Two Standard of Care Total Knee Arthroplasty ProsthesesCOMPLETEDNCT04544904The Technology, Exercise Programming, and Activity Prescription for Enhanced Mobility (TEAM) StudyCOMPLETEDNCT05488093Evaluation of Mobility in Subjects With Severe Knee Osteoarthritis Who Are to Undergo Total Knee ReplacementRECRUITING

Other records listing Biomet, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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