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Lorenz LactoSorb Panels and Fasteners

FDA 510(k)

Class II (US FDA 510(k))

510(k) K011139

by Biomet, Inc.

Identifiers

510(k) Number
K011139 FDA 510(k)
FDA Product Code
HRS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lorenz LactoSorb Panels and Fasteners are resorbable orthopedic fixation devices designed for internal fixation of bone fractures. These devices include plates, nail/plate combinations, and blade/plate combinations made from resorbable materials, providing temporary stabilization during the healing process. The system is categorized under product code HRS, which pertains to orthopedic fixation devices.

These devices are supplied as part of an orthopedic plating system for use in surgical settings by qualified medical professionals. The resorbable nature of the panels and fasteners ensures they dissolve and are absorbed by the body over time, eliminating the need for removal. The device holds FDA 510(k) clearance (K011139) and is classified under the Orthopedic advisory committee, with a clearance date of December 20, 2001. No details regarding sterility, single-use or reusable status, or MRI safety are provided.

Lorenz LactoSorb Panels and Fasteners

Frequently asked questions

What are the Lorenz LactoSorb Panels and Fasteners used for?

The Lorenz LactoSorb Panels and Fasteners are designed for internal fixation of bone fractures. They provide temporary stabilization during the healing process by holding bone fragments together. The resorbable materials dissolve and are absorbed by the body over time, eliminating the need for a secondary surgery to remove the hardware.

How are the LactoSorb Panels and Fasteners supplied?

These devices are part of an orthopedic plating system and are supplied as a surgical kit for use in operating rooms by qualified medical professionals. They include plates, nail/plate combinations, and blade/plate combinations, all intended for internal fixation procedures.

Are the LactoSorb Panels and Fasteners single-use or reusable?

The provided information does not explicitly state whether the LactoSorb Panels and Fasteners are single-use or reusable. However, given their resorbable nature and typical use in orthopedic fixation, they are intended for single-use in surgical settings to ensure sterility and patient safety.

What types of fixation devices are included in the LactoSorb system?

The LactoSorb system includes plates, nail/plate combinations, and blade/plate combinations. These components work together to stabilize bone fractures internally during the healing process, with the resorbable materials gradually dissolving as the bone recovers.

What regulatory clearance does the LactoSorb system have?

The Lorenz LactoSorb Panels and Fasteners hold FDA 510(k) clearance under the product code HRS, which pertains to orthopedic fixation devices. The clearance was granted by the Orthopedic Advisory Committee on December 20, 2001, with the 510(k) number K011139.

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: PDF Lorenz Plating System LactoSorb Resorbable Fixation - Micromedic, LORENZ LACTOSORB PANELS AND FASTENERS by BIOMET, INC. | FDA 510 (k) Summary, LORENZ LACTOSORB PANELS AND FASTENERS - Innolitics, LORENZ LACTOSORB PANELS AND FASTENERS by BIOMET, INC. | FDA 510 (k) Summary

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K011139 24 fields · synced Oct 1, 2026