OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR

• K Number: K120978
• Device Name: OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
• Manufacturer: MERETE MEDICAL GMBH
• Date Cleared: 2012-05-02 ( 30 days)
• Product Code: HSB
• Regulation Number: 888.3020
• Type: Special
• Panel: OR
• Reference & Predicate Devices: K101939
• Predicate For: N/A

Intended Use

Intramedullary knee arthrodesis

Indications include:

1. Irretrievably failed total knee arthroplasty
2. Limb salvage
3. Oncology surgery
4. Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice

The intramedullary rods can be fixed with interlocking screws without or with bone cement.

Device Description

OsteoBridge® IKA Intramedullary Knee Arthrodesis Rod Fixation System

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification decision letter from the FDA for a medical device (OsteoBridge® IKA Intramedullary Knee Arthrodesis Rod Fixation System). It is a regulatory document confirming clearance for marketing and outlines general compliance requirements.

This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications related to an AI/ML-driven medical device.

Therefore, I cannot fulfill your request for the specific information outlined in points 1-9.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.