← Product Code [JDB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDB) · K960087 # SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) (K960087) _Wrightmedicaltechnologyinc · JDB · Sep 20, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDB/K960087 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [JDB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDB.md) - **Decision Date:** Sep 20, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3160 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} WRIGHT MEDICAL TECHNOLOGY, INC 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 SEP 20 1996 K960087 510(k) Summary Contact Person: Judy English Date Prepared: 1 April 1996 Trade Name: Sorbie Resurfacing Total Elbow System Common Name: Elbow Joint Product Classification: II Predicate Device: Pritchard® Elbow System (DePuy) This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. ## Description/Intended Use The Sorbie Resurfacing Total Elbow System consists of humeral, ulnar, and radial head components. Each component is available in a range of sizes to fit varying anatomical requirements. 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. ## Materials The Sorbie Resurfacing Total Elbow System includes the following features: - humeral and ulnar metal components manufactured from cast cobalt-chromium-molybdenum, conforming to ASTM F75; - radial head metal components manufactured from wrought cobalt-chromium-molybdenum conforming to ASTM F1537; - ulnar and radial head plastic components manufactured from ultra high molecular weight polyethylene conforming to ASTM F648. ## Testing Summary | Test Description | Results | | --- | --- | | Failure force analysis of the humeral component | Compressive loading will not result in failure of the component if bony support exists. | | Stress analysis of the stemmed humeral component | Component exhibits peak stresses comparable to comparable to other devices and slightly over the fatigue strength of the material for joint forces typical of normal elbow joints. | | Stress analysis of the ulnar component | When fully supported by bone, the component exhibits stresses well within the fatigue strength of the material. | | Failure force analysis of the radial head component | All sizes demonstrate material strength properties suitable for this application. | | Ulnar component lock detail testing | Any extraction forces will be countered by compressive loading placed on the components by the humerus. | | Properties of the UHMWPE | The tensile properties of the test parts meet or exceed the minimum requirements by ASTM F 648. | 000173 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDB/K960087](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDB/K960087) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com