(81 days)
The Stabilizer Soft Tissue Anchor is a stainless steel implant intended for use as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Stabilizer placement is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and optionally securing the ACL to the implanted anchor by using up to three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures, as may be required, to the implant site during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer, and to prepare the Stabilizer for entry into the predrilled hole. If sutures are not used, use of the crimper is optional.
This document is a 510(k) Premarket Notification for a medical device called the "Stabilizer™ Soft Tissue Anchor, 6 mm," intended for ACL repair/reconstruction.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a submission to the FDA for market clearance, stating that the device is substantially equivalent to previously cleared predicate devices.
Therefore, I cannot extract the requested information, as it is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results with acceptance criteria.
§ 890.3490 Truncal orthosis.
(a)
Identification. A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.