WasherCap™ Mini Fixation System (Model 45)

The WasherCap™ Mini Fixation System (Model 45) is a soft tissue-to-bone fixation device consisting of a PEEK cap and titanium screw assembly with associated surgical instruments. It is designed to fix sutures or tapes to bone in the shoulder, knee, and hand/wrist during orthopedic procedures including meniscal repair, ACL reconstruction, rotator cuff repair, and triangular fibrocartilage complex repair in skeletally mature pediatric and adult patients.

The subject device comprises a PEEK cap component with a threaded titanium screw that is mainly screwed onto the PEEK component and partially into bone, whereas the predicate (Arthrex SwiveLock) uses an all-PEEK design with the threaded component entirely screwed into bone. Both devices are preloaded on insertion tools, but the predicate is preloaded with sutures while the subject device is not. Both use ethylene oxide sterilization.

Bacterial endotoxin testing per EP 2.6.14/USP <85>. Bench testing included cyclic loading and elongation, insertion, interconnection, and bone anchor pullout force evaluation.

Although the subject device uses PEEK and titanium (versus all-PEEK predicate) and has a different screw engagement mechanism, the 510(k) asserts these differences do not raise new safety or effectiveness questions because both devices achieve the same intended function of fixing soft tissue to bone via a threaded component. Performance testing results met acceptance criteria and were comparable to the predicate, and the subject device's narrower indications are a subset of the predicate's broader approved uses, supporting equivalence.