(29 days)
The GraftLok™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place. The GraftLok™ Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The GraftLok™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).
The GraftLok™ ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. GraftLok™ ST Screw is used to provide suspensary fixation femoral fixation during double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
The GraftLok™ Screw and GraftLok™ ST Screw are cannulated, sterile, single use bone screw manufactured from poly L-lactic acid (PLLA).
This 510(k) premarket notification for the GraftLok™ Screw and GraftLok™ ST Screw does not contain the information requested regarding acceptance criteria and performance studies.
Instead, this document:
- Asserts substantial equivalence: The core claim throughout the document is that the GraftLok™ Screw and GraftLok™ ST Screw are "substantially equivalent" to legally marketed predicate devices. This is a regulatory pathway, not a detailed performance study.
- Focuses on technological characteristics: It states that the devices "have the same technological characteristics" as predicate devices, and any differences "do not raise any concerns regarding safety and effectiveness."
- Mentions "Non Clinical Testing" documentation: It vaguely states, "Documentation provided demonstrates that the GraftLok™ Screw and GraftLok™ ST Screw are substantially equivalent..." This implies non-clinical testing was conducted, but no details of the tests, their results, or acceptance criteria are provided in the public summary.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document acts as an FDA submission summary, not a detailed study report.
§ 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.