(101 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 elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Elbow Prosthesis is intended to accomplish these goals. The Tornier Elbow prosthesis is intended for use as a cemented total elbow. The Tornier Elbow Prosthesis is a 3-part system consisting of a humeral, a 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 cup the prosthesis becomes a constrained prosthesis. The present device submission consists in the addition of two components to the previous cleared devices of the Tornier Elbow Prosthesis. 1st addition: ulnar bushing 2nd addition: individual humeral screw The fundamental scientific technology (intended use, material, manufacturing methods, packaging and sterilization) of the Tornier elbow Prosthesis has not changed relative to the predicate device.
This document is a 510(k) premarket notification for a medical device (Tornier Elbow Prosthesis), not a study report. Therefore, it does not contain the requested information about acceptance criteria, device performance, study details, sample sizes, expert involvement, or ground truth establishment.
The 510(k) document primarily focuses on establishing "substantial equivalence" to legally marketed predicate devices, rather than providing detailed clinical study data with acceptance criteria and performance metrics in the way a clinical trial report would.
Therefore, I cannot provide the requested table and study details based on the provided text.
The document states:
- Device Name: Tornier Elbow Prosthesis (Trade Name: Latitude Elbow Prosthesis)
- Intended Use: Total elbow arthroplasty to relieve severe pain or significant disability due to various conditions (osteoarthritis, rheumatoid arthritis, functional deformities, failed previous treatments, unmanageable fractures). Intended for cemented use only.
- Predicate Devices: Coonrad/Morrey Total Elbow (Zimmer), Sorbie-Questor Elbow System (Wright), and earlier Tornier Elbow Prosthesis models.
- Submission Purpose: Addition of two components: ulnar bushing and individual humeral screw. The fundamental scientific technology (intended use, material, manufacturing methods, packaging, sterilization) has not changed relative to the predicate device.
The FDA's letter (K050848) confirms that, based on the provided information, the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on comparing the new device's features, intended use, materials, and technology to that of already cleared devices, rather than requiring a new clinical efficacy study with defined acceptance criteria and performance results in this context.
§ 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.