(253 days)
I Pritchard® Elbow System (DePuy)
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No
The 510(k) summary describes a mechanical implant system for elbow arthroplasty and does not mention any AI or ML components, image processing, or data analysis related to AI/ML.
Yes
The device is indicated for conditions like degenerative joint disease, rheumatoid arthritis, correction of functional deformity, and treatment of fractures, all of which aim to reduce pain and improve function.
No
The device is an elbow arthroplasty system used for surgical replacement or resurfacing of the elbow joint, which is a treatment and not a diagnostic process.
No
The device description clearly states it consists of physical components (humeral, ulnar, and radial head components) and the performance studies focus on the mechanical properties and failure analysis of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the elbow joint to treat various conditions affecting the joint itself. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device consists of physical components (humeral, ulnar, and radial head components) designed to be implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a physical condition within the body.
N/A
Intended Use / Indications for Use
The Sorbie Resurfacing Total Elbow System is indicated for use in total clbow 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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Elbow
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
| 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. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
I Pritchard® Elbow System (DePuy)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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SEP 20 1996
K960087
Contact Person: Judy English Date Prepared: 1 April 1996
Trade Name: Sorbie Resurfacing Total Elbow System Common Name: Elbow Joint Product Classification: 【I Pritchard® Elbow System (DePuy) Predicate Device:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 8807.92.
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 clbow 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. |