Biopro Hemi-Endo Modular Head For Psl System
FDA 510(k)Class II (US FDA 510(k))
by Biopro, Inc.
Identifiers
- 510(k) Number
- K895886 FDA 510(k)
- FDA Product Code
- KWL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3360 FDA 510(k)
- Regulation Number
- 888.3360 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Prosthesis, Hip, Hemi-, Femoral, Metal (per FDA nomenclature), designed as a modular femoral head component for hemiarthroplasty. It is intended to replace the femoral head in partial hip replacements, providing articulation with the acetabular component of the PSL system. Constructed from metal, it is engineered to interface with modular necks and stems, enabling customizable hip reconstruction. The modular design allows for flexibility in surgical planning and component selection.
The Bipro Hemi-Endo Modular Head is supplied as a reusable surgical instrument, intended for use in orthopedic operating rooms. It is not sterile at the time of shipment and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The device is classified under FDA product code KWL and has received FDA 510(k) clearance (K895886) as substantially equivalent to a predicate device. No specific MRI safety classification or single-use designation is indicated in the available data.
Frequently asked questions
What is the primary use of the Bipro Hemi-Endo Modular Head in hip surgery?
The Bipro Hemi-Endo Modular Head is designed as a femoral head component for hemiarthroplasty, specifically to replace the femoral head in partial hip replacements. It articulates with the acetabular component of the PSL system, allowing for customizable hip reconstruction by interfacing with modular necks and stems.
Is the Bipro Hemi-Endo Modular Head intended for single-use or can it be reused?
The device is explicitly described as a reusable surgical instrument. It must be sterilized prior to use following standard medical device sterilization protocols, as it is not sterile at the time of shipment.
What regulatory pathway was followed for FDA clearance of this device?
The Bipro Hemi-Endo Modular Head received FDA 510(k) clearance (K895886) through a traditional review process, demonstrating substantial equivalence to a predicate device. The clearance was granted under the FDA product code KWL, which categorizes it as a Prosthesis, Hip, Hemi-, Femoral, Metal.
Are there multiple sizes or models available for the Bipro Hemi-Endo Modular Head?
Yes, the device comes in multiple sizes and models, as indicated by the extensive list of registration numbers (e.g., 3004748528, 3005913274, etc.) in the data. These likely correspond to different head diameters or configurations to accommodate varying patient anatomies and surgical needs.
How should the Bipro Hemi-Endo Modular Head be stored before use?
Since the device is reusable and not sterile at shipment, it should be stored in a clean, dry environment following manufacturer guidelines to maintain its integrity. Sterilization must be performed prior to use, adhering to established medical device sterilization protocols to ensure safety and efficacy.
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: Biopro Hemi-endo Modular Head for Psl System, BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM 510(k)… - FDA.report, PDF K895886 - Biopro Hemi-endo Modular Head for Psl System, Class 2 Device Recall BioPro Endo Head - accessdata.fda.gov, K954768 FDA 510(k) - BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K895886 | Class II | Active |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA 510(k) K895886 24 fields · synced Sep 20, 2026