Stryker Total Performance System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032117 FDA 510(k)
- FDA Product Code
- DZI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4120 FDA 510(k)
- Regulation Number
- 872.4120 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Stryker Total Performance System is a powered bone drill classified under the nomenclature for Drill, Bone, Powered. It is designed for precise cutting, drilling, decorticating, and smoothing of bone and related tissues during surgical procedures.
This system is intended for use in clinical settings and is supplied as a reusable medical device. It is regulated under FDA 510(k) clearance (K032117) as substantially equivalent to a predicate device, adhering to regulatory standards for powered surgical instruments. The system is not indicated for MRI use and requires proper maintenance and storage as per manufacturer guidelines.
Frequently asked questions
Is the Stryker Total Performance System reusable or single-use, and what maintenance does it require?
The Stryker Total Performance System is designed as a reusable medical device. Since it is intended for repeated use, it requires proper maintenance and storage as outlined by the manufacturer to ensure performance, safety, and sterility between procedures. The manufacturer’s guidelines must be followed strictly to prevent contamination or damage.
Can this device be used in MRI environments, or are there any restrictions?
The Stryker Total Performance System is not indicated for MRI use. This restriction is explicitly stated in the device’s documentation, meaning it should not be operated or stored in an MRI environment due to potential interference or safety risks.
What types of surgical procedures is this bone drill intended for, and what tissues can it cut?
The Stryker Total Performance System is designed for precise cutting, drilling, decorticating, and smoothing of bone and related tissues during surgical procedures. While the device is classified under powered bone drills, its intended use is not limited to a specific clinical indication—rather, it supports general orthopedic, dental, or reconstructive surgeries where controlled bone manipulation is required.
How is the device regulated, and what does the FDA clearance (K032117) mean for its use?
The Stryker Total Performance System holds an FDA 510(k) clearance (K032117), meaning it has been determined to be substantially equivalent to a predicate device already on the market. This clearance confirms that the device meets FDA regulatory standards for safety and effectiveness as a powered bone drill, but it does not specify clinical indications—only that it adheres to the requirements for such instruments. Clinicians should refer to the manufacturer’s instructions for proper use.
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: Stryker TPS - Total Performance System - Surgical Power Tools, PDF Stryker TPS - Total Performance System Surgical Power Tools, Power tools - Stryker, STRYKER TPS 5100-1 USER MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032117 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
Sources (1)
- FDA 510(k) K032117 24 fields · synced Sep 19, 2026