Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories
FDA 510(k)Class II (US FDA 510(k))
by Prosurg Inc
Identifiers
- 510(k) Number
- K070737 FDA 510(k)
- FDA Product Code
- JEY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4760 FDA 510(k)
- Regulation Number
- 872.4760 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xsorb Bioabsorbable Craniofacial Bone Fixation System is a bioabsorbable orthopedic device designed for craniofacial bone stabilization. It consists of plates, meshes, screws, fasteners, and tacks fabricated from a copolymer of Poly(L-Lactide & DL-Lactide). This system is intended for use in trauma and reconstructive surgeries to secure bone segments, providing temporary fixation that gradually resorbs over time.
The system is supplied as a sterile, single-use device and is classified under FDA product code JEY as a Class II Bone Plate. It is regulated under the FDA’s 510(k) clearance process, with a decision of Substantially Equivalent issued in 2007. Components are intended for use in controlled surgical environments, adhering to regulatory standards for bioabsorbable materials and craniofacial applications.
Frequently asked questions
What types of surgical procedures is the Xsorb Bioabsorbable Craniofacial Bone Fixation System intended for?
The Xsorb system is designed specifically for craniofacial bone stabilization in trauma and reconstructive surgeries. It provides temporary fixation for bone segments, gradually resorbing over time as the bone heals. This makes it suitable for procedures requiring bioabsorbable support in the craniofacial region.
Is the Xsorb system reusable or intended for single-use only?
The Xsorb Bioabsorbable Craniofacial Bone Fixation System is explicitly supplied as a sterile, single-use device. This ensures patient safety and compliance with surgical best practices for bioabsorbable materials, which should not be reused due to potential degradation or contamination risks.
What materials are used in the Xsorb system, and how does this affect its use?
The system is fabricated from a copolymer of Poly(L-Lactide & DL-Lactide), a bioabsorbable material that gradually resorbs over time. This design eliminates the need for removal surgery, as the fixation dissolves naturally after stabilizing the bone, making it ideal for temporary craniofacial stabilization.
How is the Xsorb system regulated by the FDA, and what does this mean for clinicians?
The Xsorb system is regulated under the FDA’s 510(k) clearance process and classified as a Class II Bone Plate under product code JEY. It received a *Substantially Equivalent* decision in 2007, meaning it meets FDA standards for safety and effectiveness comparable to legally marketed predecessors. Clinicians can rely on its compliance with regulatory requirements for bioabsorbable craniofacial fixation.
Are there multiple sizes or models available for the Xsorb system, and how can I identify them?
The system includes a variety of components such as plates, meshes, screws, fasteners, and tacks, each with distinct registration numbers (e.g., 3011302692, 3003322138). These identifiers correspond to specific sizes and configurations, allowing surgeons to select the appropriate components for their procedure. The manufacturer’s documentation should detail compatibility and usage for each variant.
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: Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories ..., Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories, K070737 FDA 510(k) - XSORB BIOABSORBABLE CRANIOFACIAL BONE F..., Xsorb Bioabsorbable Craniofacial Bone Fixation System & Accessories ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070737 | Class II | Active |
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Manufacturer
- Manufacturer
- Prosurg Inc
- FDA Applicant
- Prosurg, Inc.
Sources (1)
- FDA 510(k) K070737 24 fields · synced Sep 20, 2026