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FDA 510(k)

b-ONE® Total Hip System

K-Number: K240528 · 2024-11-15

ApplicantB-One Ortho, Corp.
Decision Date2024-11-15
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

b-ONE® Total Hip System is a medical device manufactured by B-One Ortho, Corp.. It received FDA 510(k) clearance on 2024-11-15 under approval number K240528. 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 b-ONE® Total Hip System?

b-ONE® Total Hip System is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by B-One Ortho, Corp.. The 510(k) number is K240528.

When was b-ONE® Total Hip System approved by the FDA?

b-ONE® Total Hip System received FDA 510(k) clearance on 2024-11-15, under approval number K240528.

What company makes b-ONE® Total Hip System?

b-ONE® Total Hip System is manufactured by B-One Ortho, Corp..

What is the FDA product code for b-ONE® Total Hip System?

The FDA product code for b-ONE® Total Hip System is LZO.

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 NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) 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) PMID: 28280294 Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. Journal of health care finance (2016)

Other Devices by B-One Ortho, Corp.

K180446b-ONE Total Knee System K173380b-ONE® Total Hip System K182705Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component K202429Mobio Total Knee System K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

View all 12 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.

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