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)

Platform® Acetabular System

K-Number: K220483 · 2022-09-23

ApplicantTotal Joint Orthopedics, Inc.
Decision Date2022-09-23
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Platform® Acetabular System is a medical device manufactured by Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2022-09-23 under approval number K220483. 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 Platform® Acetabular System?

Platform® Acetabular System is a medical device that received FDA 510(k) clearance on 2022-09-23. It is manufactured by Total Joint Orthopedics, Inc.. The 510(k) number is K220483.

When was Platform® Acetabular System approved by the FDA?

Platform® Acetabular System received FDA 510(k) clearance on 2022-09-23, under approval number K220483.

What company makes Platform® Acetabular System?

Platform® Acetabular System is manufactured by Total Joint Orthopedics, Inc..

What is the FDA product code for Platform® Acetabular System?

The FDA product code for Platform® Acetabular System is LZO.

Related Clinical Trials

NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING NCT07603609 Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain RECRUITING NCT07593807 TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis ACTIVE_NOT_RECRUITING NCT03636230 Virtual E-health System for Pacemakers ACTIVE_NOT_RECRUITING NCT07587593 The IVCare Adaptive Platform Trial NOT_YET_RECRUITING NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 37288633 [Roadmap of Medical Device for Implanted Brain-computer Interface]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018)

Other Devices by Total Joint Orthopedics, Inc.

K162422Klassic Knee System K162256Klassic Femur, Porous, Klassic Tibial Baseplate, Porous K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly K180929Klassic HD® Hip System K180159Klassic® Knee System K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly

View all 11 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.

↑