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)

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

K-Number: K214109 · 2022-10-28

ApplicantKontour(Xi’An) Medical Technology Co., Ltd.
Decision Date2022-10-28
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is a medical device manufactured by Kontour(Xi’An) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-28 under approval number K214109. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)?

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by Kontour(Xi’An) Medical Technology Co., Ltd.. The 510(k) number is K214109.

When was PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) approved by the FDA?

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) received FDA 510(k) clearance on 2022-10-28, under approval number K214109.

What company makes PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)?

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is manufactured by Kontour(Xi’An) Medical Technology Co., Ltd..

What is the FDA product code for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)?

The FDA product code for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is GXN.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT06859970 An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (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: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026)

Related Devices (Code: GXN)

K160707CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K171507CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K161090Cranial PSIOssdsign AB K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc. K180513CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC

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.

↑