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

FDA 510(k)

TRICON UNICOMPARTMENTAL KNEE SYSTEM

K-Number: K854325 · 1985-12-09

ApplicantRichards Medical Co., Inc.
Decision Date1985-12-09
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRICON UNICOMPARTMENTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1985-12-09 under 510(k) number K854325. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRICON UNICOMPARTMENTAL KNEE SYSTEM?

TRICON UNICOMPARTMENTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K854325.

When did TRICON UNICOMPARTMENTAL KNEE SYSTEM receive FDA 510(k) clearance?

TRICON UNICOMPARTMENTAL KNEE SYSTEM received FDA 510(k) clearance on 1985-12-09, under 510(k) number K854325.

Who is the listed applicant for TRICON UNICOMPARTMENTAL KNEE SYSTEM?

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

What is the FDA product code for TRICON UNICOMPARTMENTAL KNEE SYSTEM?

The FDA product code for TRICON UNICOMPARTMENTAL KNEE SYSTEM is HSX.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Richards Medical Co., 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

View all 71 devices →

Related Devices (Code: HSX)

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.

K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer BiometK251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.

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.

↑