(85 days)
Indications for the Resorbable Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.
The Resorbable Screw Anchor is a screw-type anchor used to provide means for attaching soft tissue to bone during healing. The device is manufactured from an 85% L-Lactide/15% Glycolide material and is available in two sizes, 3.5 mm and 5.5 mm. The screw anchor consists of a screw portion and a head portion.
The 3.5 mm size anchor will be available with a monofilament suture, #1 suture, or #2 suture while the 5.5 mm size anchor will be available with a monofilament suture, two #2 sutures or a #5 suture. The Resorbable Screw Anchor will be packaged sterile and will be preloaded on a driver with suture.
The provided K012872 document describes a Resorbable Screw Anchor and indicates that clinical testing was NOT used to establish substantial equivalence to predicate devices. Instead, it states:
"Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices."
Therefore, the requested information regarding acceptance criteria, study details, and performance based on clinical data is not available in these documents. The submission relies solely on mechanical testing to demonstrate substantial equivalence to previously marketed devices.
This means that a study proving the device meets acceptance criteria, as a clinical study would typically do, was not conducted or submitted for this 510(k) clearance.
§ 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.