(24 days)
To provide fixation to bone of the tibial and/or femoral end of a bone-patellar tendon-bone graft or other soft tissue graft material used to reconstruct the ACL and/or PCL in an intraarticular procedure of the knee.
The Soft Tissue Suture Washer is a titanium alloy (Ti-6A1-4V) three-hole suture washer that is intended to be used with cancellous or cortical bone screws. This suture washer is designed to prevent migration of screw head into the bone and provide an anchoring site for sutures.
The provided document K991135 is a 510(k) Pre-Market Notification for a medical device called the "Soft Tissue Suture Washer." This document focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a study that proves the device meets specific acceptance criteria through performance testing.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving device performance.
Instead, the submission states:
- Substantial Equivalence Basis: "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standard ASTM F136."
- Predicate Device: The Soft Tissue Suture Washer is substantially equivalent to the current DePuy OrthoTech Soft Tissues Suture Washer (K910229).
This means that the device's acceptability is based on its similarity to a device already on the market (the predicate device) and its compliance with a consensus standard (ASTM F136) which likely covers mechanical properties or material specifications for such devices. The document does not describe a clinical study or a performance study with defined acceptance criteria and statistical analysis as is typical for demonstrating efficacy or safety in other types of submissions.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.