(17 days)
Lorenz Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.
The Lorenz Sternal Closure System 2.4 self drilling screws are 2.4 mm in diameter and the lengths may range up to I the Lorental Storal Clobal v Systems so that a preditled hole is not required, but may be used.
This document is a 510(k) premarket notification for the "Lorenz Sternal Closure System," which is a metallic bone fixation appliance. The FDA determination is that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, device performance data, study details (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any multi-reader multi-case (MRMC) or standalone studies.
The document primarily focuses on:
- Device Name: Lorenz Sternal Closure System
- Classification: Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030), Class II.
- Intended Use: Stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
- Description: 2.4 mm self-drilling screws with variable lengths.
- Sterility: Marketed as non-sterile, single-use, with steam sterilization recommendations for hospitals.
- Substantial Equivalence: Claimed to be equivalent to Lorenz 2.4 Self Drilling Screw (K03228) and Lorenz Sternal Closure System (K011076).
- Possible Risks: Lists several potential complications associated with implants and surgical procedures.
- FDA Clearance: A letter from the FDA confirming substantial equivalence to predicate devices, allowing the device to be marketed.
Therefore, I cannot provide the requested table or details about acceptance criteria and study results because this information is not present in the provided text.
If this were a document about a software device or an AI/ML product, it would typically include a dedicated section for performance data, acceptance criteria, and study methodologies to demonstrate clinical efficacy and safety. For a physical implantable device like this, substantial equivalence is often established through material testing, mechanical performance testing (not detailed here), and comparison to predicate devices, rather than clinical studies with human readers or AI performance metrics.
§ 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.