(72 days)
No changes are made to the intended use of the Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis® implants as a result of this modification. Indications for use include: - Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis; and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - Patients with failed previous surgery where pain, deformity, or dysfunction persists. - Revision of previously failed hip arthroplasty.
The Wagner SL Revision Stem Lateral is a straight stem manufactured from forged titanium alloy and is available in four lengths. The neck design of the stem is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper. The Wagner SL Revision Stem Lateral incorporates a circular stem crosssection and equally spaced conical anchorage ribs, which run nearly the full length of the stem. The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles. 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm. No changes are being made to the Wagner SL Revision Stem Lateral and the Wagner Cone Prosthesis implants, but one change to the Awls is proposed in this submission: An additional energy type for driving the Wagner -SL Awls and Wagner Cone Awls is introduced: from manually powered use only to manually and power driven use. While manually reaming is still possible the proposed modification enables the use of the awls connected to a powered device to ream the femoral medullary canal.
This document is a 510(k) premarket notification for a medical device (Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System) and does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.
The document is for a hip joint prosthesis and the only modification proposed is to the awls used to ream the femoral medullary canal, specifically introducing an additional energy type for driving the awls (from manually powered only to manually and power driven use).
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, as is common for 510(k) submissions for traditional medical devices.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.