FDA 510(k)

FitRite Total Hip Arthroplasty System

K-Number: K153057 · 2016-06-23

Decision Date2016-06-23

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FitRite Total Hip Arthroplasty System is a medical device manufactured by Excera Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-06-23 under approval number K153057. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FitRite Total Hip Arthroplasty System?

FitRite Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2016-06-23. It is manufactured by Excera Orthopedics, Inc.. The 510(k) number is K153057.

When was FitRite Total Hip Arthroplasty System approved by the FDA?

FitRite Total Hip Arthroplasty System received FDA 510(k) clearance on 2016-06-23, under approval number K153057.

What company makes FitRite Total Hip Arthroplasty System?

FitRite Total Hip Arthroplasty System is manufactured by Excera Orthopedics, Inc..

What is the FDA product code for FitRite Total Hip Arthroplasty System?

The FDA product code for FitRite Total Hip Arthroplasty System is JDI.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07613203 Forced-Air Warming for Preventing Perioperative Hypothermia During Total Knee Arthroplasty COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40025985 Patient-reported outcome measures offer little additional value two years after arthroplasty : a systematic review and meta-analysis. The bone & joint journal (2025)

Related Devices (Code: JDI)

K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. K153725Corin TaperFit Hip StemCorin U.S.A. Limited K153216Alpine Cemented Hip SystemOrtho Development Corporation K162125MALUC Total Hip Arthroplasty SystemSurgtech, Inc. K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc. K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.