(155 days)
The Tornier Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthtitis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Tornier Elbow Prosthesis is intended for cemented use only.
Total Elbow replacement is used to treat a number of clinical conditions such as severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. It is also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of such surgery is to restore the cloow joint to its best working condition and to reduce or eliminate pain. The Latitude Tornier Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow.
The Latitude Tornier Elbow Prosthesis is a 3-part system consisting of a humeral, an ulnar and a radial component. The humeral implant is modular and consists in the assembly of various sizes of humeral stem and humeral spool in order to better reproduce the functionality of the natural humerus.
The prosthesis is a non-constrained prosthesis and when it is used with the ulnar cap the prosthesis becomes a semi-constrained prosthesis.
The present device submission corresponds to a modification in the assembly of the humeral stem with the humeral spool. Included in the modification the material of the ring stop has changed from UHMWPE to PEEK-OPTIMA. The radial components and the ulnar components are not modified. The technological characteristics (design, materials, manufacturing, sterilization, sizing and indications) of the modified humeral spool and humeral screw components are similar or identical to the predicate devices.
The provided text is a summary of safety and effectiveness information for a medical device (Latitude Tornier Elbow Prosthesis) and correspondence from the FDA regarding its 510(k) submission. It does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications for a clinical validation study.
The document primarily focuses on:
- Device classification and regulatory information.
- Device description, materials, and intended use.
- The FDA's determination of substantial equivalence to predicate devices, allowing the device to be marketed.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document is a regulatory approval notice, not a clinical study report.
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.