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Zimmer Patient Specific Instruments Planner

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112301

by Materialise NV

Identifiers

510(k) Number
K112301 FDA 510(k)
FDA Product Code
HSX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3520 FDA 510(k)
Regulation Number
888.3520 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Zimmer Patient Specific Instruments Planner is a surgical instrument intended to assist in the positioning of Total Knee Replacement components intraoperatively and Zimmer Unicompartmental High Flex Knee System prostheses components intraoperatively and in guiding the marking of bone before cutting. It is designed for use with Zimmer Unicompartmental High Flex Knee System prostheses families only.

The device is supplied as a single-use instrument and is intended for use in a surgical setting. It has received FDA 510(k) clearance under K-number K112301 and is manufactured by Materialise NV. No information regarding sterility, MRI safety, sizes, storage, or additional authorisations is provided in the data.

Frequently asked questions

What is the Zimmer Patient Specific Instruments Planner used for?

It is intended to assist in the positioning of Total Knee Replacement components and Zimmer Unicompartmental High Flex Knee System prostheses components intraoperatively, and in guiding the marking of bone before cutting, specifically for use with Zimmer Unicompartmental High Flex Knee System prostheses families only.

Is the Zimmer Patient Specific Instruments Planner reusable or single-use?

The device is supplied as a single-use instrument, meaning it is intended for one procedure only and should not be reprocessed or reused due to design and material constraints that could compromise safety or function.

Who manufactures the Zimmer Patient Specific Instruments Planner and what is its regulatory clearance?

The device is manufactured by Materialise NV and has received FDA 510(k) clearance under K-number K112301, indicating it was found substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Zimmer Patient Specific Instruments/ System/Planner, Zimmer Patient Specific Instruments, Zimmer Patient Specific ..., K111492 - ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA... | FDA 510(k), Materialise NV 00-5970-000-33 Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Materialise NV

Sources (1)

  • FDA 510(k) K112301 24 fields · synced Sep 22, 2026