Question 1

What types of medical devices does Kontour(Xi'An) Medical Technology Co., Ltd. manufacture?

Accepted Answer

Kontour(Xi'An) Medical Technology Co., Ltd. specializes in two primary device categories: patient-specific cranial and craniofacial implants made from PEEK (polyether ether ketone) for cranioplasty, and single-use surgical screwdrivers. The implants are designed to restore skull integrity after surgical resection and are tailored to individual patient anatomy, while the screwdrivers are used for fixing cranial plates. These devices are tailored for reconstructive cranial surgeries.

Question 2

Where is Kontour(Xi'An) Medical Technology Co., Ltd. based?

Accepted Answer

The company is based in the United States. This location is relevant for regulatory oversight and compliance with U.S. medical device regulations, including those governing manufacturing, distribution, and post-market surveillance.

Question 3

Which regulatory registries list devices manufactured by Kontour(Xi'An) Medical Technology Co., Ltd.?

Accepted Answer

Devices from Kontour(Xi'An) Medical Technology Co., Ltd. are listed in the FDA’s 510(k) and UDI (Unique Device Identifier) databases. The 510(k) registry is used for premarket submissions of Class II devices, while the UDI system ensures traceability and identification of medical devices throughout their lifecycle, including post-market surveillance.

Question 4

How are devices manufactured by Kontour(Xi'An) Medical Technology Co., Ltd. classified under FDA regulations?

Accepted Answer

The company’s devices are classified under FDA Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and requirements for each device type.

Question 5

What is the primary purpose of the patient-specific cranial implants produced by Kontour(Xi'An) Medical Technology Co., Ltd.?

Accepted Answer

The patient-specific cranial implants are designed for cranioplasty, which involves reconstructing the skull after surgical resection—such as tumor removal or trauma repair. These implants are non-alterable and made from PEEK, a biocompatible material, to restore anatomical integrity and function while minimizing the risk of complications like infection or rejection.

Device	Model / Reference	Registries	Class	Status
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T2L7H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T8L6H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T3L7H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T8L11H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T3L3H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T3L11H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T6L6H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L7H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T4L13H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T4L2H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T9L3H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T9L18H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L1H1	FDA UDI	Class II	Unknown
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T6L4H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T8L18H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T4L8H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T9L16H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L8H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L5H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T8L17H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L9H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T9L12H2	FDA UDI	Class II	Active
Disposable Screwdriver Blade	BPLD50×φ2.8	FDA UDI	Class I	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T3L16H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T4L4H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T5L13H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T3L10H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T3L9H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T5L12H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T3L18H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T9L6H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T8L15H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T8L8H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L4H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T4L18H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T7L1H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T9L10H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T5L5H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T2L17H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T2L9H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L17H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T3L13H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L11H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T8L16H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T4L10H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T7L11H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T2L15H2	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T2L6H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L6H1	FDA UDI	Class II	Active
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)	KT-T1L16H2	FDA UDI	Class II	Active

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