PerFuse Percutaneous Decompression System
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K141762 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PerFuse Percutaneous Decompression System is a device designed to access the femoral or humeral head for core decompression. It is intended to facilitate the delivery of bone graft material to an orthopedic site, including mixing and pre-mixing of bone graft material with I.V. fluids, blood, plasma, bone marrow, or other specified blood components as determined by clinical use.
The system is supplied as a surgical instrument for use in orthopedic procedures. It is authorized under FDA 510(k) clearance (K141762) with product code FMF and is manufactured by Biomet, Inc. The device is intended for use in a general hospital setting as indicated by the advisory committee classification.
Frequently asked questions
What is the purpose of the PerFuse Percutaneous Decompression System?
The PerFuse Percutaneous Decompression System is designed to access the femoral or humeral head for core decompression and facilitate the delivery of bone graft material to orthopedic sites, including mixing with various fluids or blood components.
How is the PerFuse Percutaneous Decompression System supplied?
The system is supplied as a surgical instrument for use in orthopedic procedures, manufactured by Biomet, Inc., and intended for use in a general hospital setting.
What regulatory clearance does the PerFuse Percutaneous Decompression System have?
The device has FDA 510(k) clearance (K141762) with product code FMF, classified under the decision code SESE as substantially equivalent.
Can the PerFuse Percutaneous Decompression System be used with different types of bone graft materials?
Yes, the system is designed to facilitate the delivery and mixing of bone graft material with I.V. fluids, blood, plasma, bone marrow, or other specified blood components as determined by clinical 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: PerFuse™ Percutaneous Core Decompression System - Zimmer Biomet, PDF PerFuse Percutaneous Core Decompression Instrumentation - Zimmer Biomet, PerFuse™ Percutaneous Decompression System Surgical Technique
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141762 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K141762 24 fields · synced Sep 19, 2026