(121 days)
The RIGIDLOOP Titanium Button is intended for fixation of soft-tissue to bone for the following indications when used with PERMATAPE™ 2.5mm Suture, #2 ORTHOCORD® Suture, #2 DYNACORD™ Suture, or equivalent nonabsorbable or partially-absorbable high strength operative suture:
Shoulder:
Acromioclavicular repair
Pectoralis major / minor repair1
Biceps tenodesis
Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment
Knee:
Cruciate ligament reconstruction1
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair2
1 PERMATAPE 2.5mm suture must be used for pectoralis major/minor repair and cruciate ligament reconstruction
2 Size 0 or size 2/0 ORTHOCORD Suture may be used for meniscal root repair.
RIGIDLOOP Cortical Fixation System XL Implant
When used in conjunction with the RIGIDLOOP Cortical Fixation System, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs.
When used in conjunction with the RIGIDLOOP Titanium Button, the RIGIDLOOP Cortical Fixation System XL Implant is intended for fixation of soft-tissue to bone for the following indications:
Shoulder:
Pectoralis major / minor repair
Biceps tenodesis
Elbow:
Ulnar or radial collateral ligament reconstruction
Biceps tendon reattachment
Knee:
Cruciate ligament reconstruction
Extracapsular repair: MCL, LCL, and Posterior oblique ligament
Patellar tendon repair
Meniscal root repair
RIGIDLOOP Titanium Button
The proposed RIGIDLOOP Titanium Button is a cortical fixation device that provides a means of fixation of soft tissue to bone in orthopedic reconstructive surgery. The device consists of a titanium button implant that is provided with pre-attached leading and trailing sutures that are non-implantable. The white leading utility suture is composed of UHMWPE (device high molecular weight polyethylene) and the green trailing suture is composed of #5 Ethibond®. This device is provided sterile and is for single use only.
RIGIDLOOP Cortical Fixation System XL Implant
The RIGIDLOOP XL Implant is an extra-large titanium button implant that is currently intended for use with the already cleared RIGIDLOOP Cortical Fixation System devices (K130814). The RIGIDLOOP XL Implant can now also be used with the proposed RIGIDLOOP Titanium Button for the proposed indications. The RIGIDLOOP XL Implant is used in cases of cortical breaching. This device is provided sterile and is for single use only.
The provided text describes the regulatory clearance for the RIGIDLOOP™ Titanium Button and RIGIDLOOP™ Cortical Fixation System XL Implant. It does not contain information about a medical device involving AI, image analysis, or any study that would typically involve acceptance criteria related to accuracy, sensitivity, or specificity.
Specifically, the document focuses on:
- The FDA's 510(k) clearance for a surgical implant (bone fixation fastener).
- The device's indications for use (fixation of soft-tissue to bone for various orthopedic repairs).
- A comparison to predicate devices, emphasizing substantial equivalence based on material, design, and non-clinical performance testing (e.g., fixation strength, biological safety, sterility, packaging, shelf-life).
- A clear statement: "No animal or clinical studies were required."
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance (including accuracy metrics, sample sizes, expert ground truth, etc.) because such information is not present in the provided text. The device described is a physical implant, not a software or AI-based diagnostic/assessment tool.
§ 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.