Zimmer Patient Specific Instrument System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113829 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Zimmer Patient Specific Instrument System is a surgical instrument designed to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. It streamlines total knee replacement surgery by ensuring accurate and reproducible guide fixation, with proprietary stabilizing features that enhance guide fixation while ensuring the end surgical result matches the preoperative plan.
Based on the patient's MRI, mechanical axis-based pin guides conform precisely to the patient's anatomy. The system is supplied as part of a surgical instrument kit and is intended for use in total knee replacement procedures where anatomic landmarks necessary for alignment are present. The device has received FDA 510(k) clearance with the product code JWH and is manufactured by Materialise NV in Leuven, Belgium.
Frequently asked questions
What is the Zimmer Patient Specific Instrument System used for?
The Zimmer Patient Specific Instrument System is designed to assist in positioning total knee replacement components during surgery and guide bone marking before cutting. It ensures accurate and reproducible guide fixation to match the preoperative surgical plan.
How is the Zimmer Patient Specific Instrument System supplied?
The system is supplied as part of a surgical instrument kit intended for use in total knee replacement procedures where anatomic landmarks necessary for alignment are present.
What is the regulatory status of the Zimmer Patient Specific Instrument System?
The device has received FDA 510(k) clearance with the product code JWH. It is manufactured by Materialise NV in Leuven, Belgium, and was cleared on April 2, 2012.
How does the Zimmer Patient Specific Instrument System work?
Based on the patient's MRI, mechanical axis-based pin guides conform precisely to the patient's anatomy. The system features proprietary stabilizing elements that enhance guide fixation while ensuring the surgical result matches the preoperative plan.
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: Effiziente Automatisierungstechnik - Zimmer Group, PDF Zimmer Patient Specific Instruments - hungerfordmd.com, Zimmer Patient Specific Instrument System Zimmer Patient Specific ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113829 | Class II | Active |
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Manufacturer
- Manufacturer
- Materialise NV
Sources (1)
- FDA 510(k) K113829 24 fields · synced Sep 21, 2026