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)

Apex 3D Total Ankle Replacement System

K-Number: K210390 · 2021-03-06

ApplicantParagon 28, Inc.
Decision Date2021-03-06
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Apex 3D Total Ankle Replacement System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2021-03-06 under approval number K210390. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Apex 3D Total Ankle Replacement System?

Apex 3D Total Ankle Replacement System is a medical device that received FDA 510(k) clearance on 2021-03-06. It is manufactured by Paragon 28, Inc.. The 510(k) number is K210390.

When was Apex 3D Total Ankle Replacement System approved by the FDA?

Apex 3D Total Ankle Replacement System received FDA 510(k) clearance on 2021-03-06, under approval number K210390.

What company makes Apex 3D Total Ankle Replacement System?

Apex 3D Total Ankle Replacement System is manufactured by Paragon 28, Inc..

What is the FDA product code for Apex 3D Total Ankle Replacement System?

The FDA product code for Apex 3D Total Ankle Replacement System is HSN.

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 NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING

Related PubMed Literature

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: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

Other Devices by Paragon 28, Inc.

K170693Phantom Small Bone Intramedullary Nail System K182148SILVERBACK Gorilla Plating System K191782TTC Phantom Intramedullary Nail System K190365Baby Gorilla/Gorilla Plating System K190586Monster® Screw System K183690Tenodesis Screw System

View all 50 devices →

Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc

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.

↑