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Kennedy LAD Ligament Augmentation Device

FDA PMA

Class III (US FDA PMA)

PMA P850069

by 3m Company

Identity

Trade Name
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE FDA PMA
Generic Name
LIGAMENTS AND TENDONS, SYNTHETIC FDA PMA

Identifiers

PMA Number
P850069 FDA PMA
FDA Product Code
LML FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Orthopedic FDA PMA
FDA Decision
APWD FDA PMA

The Kennedy LAD Ligament Augmentation Device is a synthetic ligament and tendon augmentation implant classified under the generic name ‘Ligaments and Tendons, Synthetic.’ Designed as an orthopedic device, it is intended to provide structural support to injured ligaments, particularly in the knee, by reinforcing natural tissue during the healing process. Constructed from biocompatible materials, it integrates with the body’s own tissue to restore stability and function. This device falls under the FDA’s Class III regulatory category, requiring Premarket Approval (PMA) due to its significant risk profile.

This device is supplied sterile and intended for single-use in surgical settings, where it is affixed to injured ligaments to assist in their repair and stabilization. It is regulated under FDA PMA P850069 and associated revisions, ensuring compliance with stringent safety and performance standards. The device is not MRI-safe and must be handled with sterile technique prior to implantation. Storage instructions specify protection from moisture and contamination, maintaining sterility until use.

Frequently asked questions

What is the Kennedy LAD Ligament Augmentation Device primarily used for in surgical settings?

The Kennedy LAD Ligament Augmentation Device is designed to provide structural support to injured ligaments, specifically in the knee, during the healing process. It reinforces natural tissue to restore stability and function, assisting in ligament repair and stabilization.

Is the Kennedy LAD Ligament Augmentation Device intended for reuse or single-use, and how should it be handled before surgery?

The device is intended for single-use only and must be handled with sterile technique prior to implantation. It is supplied sterile, so maintaining sterility—protecting it from moisture and contamination—is critical until use.

What storage conditions are required to preserve the sterility of the Kennedy LAD Ligament Augmentation Device?

The device must be stored in a way that protects it from moisture and contamination to ensure sterility is maintained until use. Avoid exposing it to environmental contaminants or humidity.

Can the Kennedy LAD Ligament Augmentation Device be used in MRI scans, and what regulatory approval does it hold?

The device is not MRI-safe, so it cannot be used in MRI environments. It holds FDA Premarket Approval (PMA P850069), meeting stringent safety and performance standards for Class III orthopedic implants.

What materials is the Kennedy LAD Ligament Augmentation Device made from, and how does it integrate with the body?

The device is constructed from biocompatible materials designed to integrate with the body’s own tissue. This integration helps restore stability and function to injured ligaments during the healing process.

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: KENNEDY LAD (TM) LIGAMENT AUGMENTATION DEVICE (P850069) — FDA 510 (k ..., Kennedy Lad (Tm) Ligament Augmentation Device, Kennedy Lad (Tm) Ligament Augmentation Device, Kennedy Lad (Tm) Ligament Augmentation Device, Ligament Augmentation Device - an overview - ScienceDirect

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA PMA P850069 24 fields · synced Sep 20, 2026