SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
Device Facts
| Record ID | K960087 |
|---|---|
| Device Name | SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) |
| Applicant | Wrightmedicaltechnologyinc |
| Product Code | JDB · Orthopedic |
| Decision Date | Sep 20, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3160 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Sorbie Resurfacing Total Elbow System is indicated for use in total elbow arthroplasty for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.
Device Story
Total elbow arthroplasty system comprising humeral, ulnar, and radial head components; available in multiple sizes for anatomical fit. Used by orthopedic surgeons in clinical/OR settings to replace damaged joint surfaces. Components implanted to restore joint function and reduce pain. Clinical benefit derived from mechanical reconstruction of elbow joint.
Clinical Evidence
Bench testing only. Evaluated failure force and stress analysis for humeral, ulnar, and radial head components. UHMWPE tensile properties verified against ASTM F648. Results indicate component strength and stress profiles are suitable for clinical application.
Technological Characteristics
Humeral/ulnar metal components: cast CoCrMo (ASTM F75). Radial head metal: wrought CoCrMo (ASTM F1537). Plastic components: UHMWPE (ASTM F648). Modular design with multiple sizes.
Indications for Use
Indicated for skeletally mature patients requiring total elbow arthroplasty for pain relief or functional improvement due to noninflammatory/inflammatory degenerative joint disease, functional deformity, failed prior treatments, or unmanageable fractures.
Regulatory Classification
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).
Predicate Devices
- Pritchard® Elbow System (DePuy)
Related Devices
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- K183618 — Revolution Radial Head · Ignite Orthopedics, Inc. · May 17, 2019
- K182461 — LATITUDE EV Total Elbow Arthroplasty · Tornier, Inc. · Dec 27, 2018
- K992656 — DEPUY TOTAL ELBOW SYSTEM · DePuy Orthopaedics, Inc. · Nov 5, 1999
- K090473 — DISCOVERY ELBOW - X-SMALL · Biomet Manufacturing Corp · Mar 25, 2009
