(86 days)
The ConMed Linvatec Intercept implants are for attaching soft tissue to bone in orthopedic surgical procedures to be used in either arthroscopic or open surgical procedures: The Intercept implants are intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.
The ConMed Linvatec Intercept Implant is a device that is used to assist the surgeon in re-attaching soft tissue to bone via interference fixation. The system includes implants, manufactured of PEEK (polyetheretherketone) material, in a range of sizes from 5mm to 8mm diameters and 12mm to 23mm lengths. A disposable driver is also part of the system.
This document is a 510(k) summary for a medical device (ConMed Linvatec Intercept Implant) and does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor any clinical trial data relevant to the questions asked.
The document solely focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, principles of operation, and technical characteristics. It discusses:
- Device Name: ConMed Linvatec Intercept Implant
- Submitter and Contact Information
- Classification Information
- Predicate Devices: ConMed Linvatec Matryx Interference Screw (K063588) and Arthrex Interference PEEK Screw (K062466)
- Device Description: PEEK implants (5mm-8mm diameter, 12mm-23mm length) and a disposable driver.
- Intended Use/Indications: Attaching soft tissue to bone via interference fixation in orthopedic procedures (arthroscopic or open).
- Substantial Equivalence Claim: Based on design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate devices.
- FDA Communication: Letter confirming substantial equivalence, general controls, and other regulatory requirements.
- Indications for Use Statement.
Therefore, I cannot provide the requested information from the provided text. The document describes a regulatory submission process (510(k)) that relies on equivalence to existing devices rather than a de novo clinical study with acceptance criteria and performance data as typically seen for new technologies or algorithms.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.