(99 days)
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Not Found
No
The description focuses on the mechanical properties and materials of a hip implant, with no mention of AI or ML.
Yes
The device is described as being "used to resurface the femoral hip joint and reconstitute function following the degenerative effects of osteo and rheumatoid arthritis, post trauma disease effects, avascular necrosis and septic total hip revision," which indicates it is intended to treat a medical condition.
No
The device description indicates that it is a femoral hip system used to resurface joints and reconstitute function, addressing mechanical rather than diagnostic needs.
No
The device description clearly outlines a physical implantable device made of cobalt chrome alloy, including stems, collars, and coatings, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "femoral hip system" used to "resurface the femoral hip joint and reconstitute function" due to various conditions affecting the hip joint. This is a surgical implant, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The devices are used to resurface the femoral hip joint and reconstitute function following the degenerative effects of osteo and rheumatoid arthritis. post trauma disease effects, avascular necrosis and septic total hip revision.
Product codes
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Device Description
A femoral hip system consisting of standard and long stem options with or without calcar collars, plasma sprayed either proximally or five eighths of stem and for use with or without a PMMA cement centralizer. The devices are used to resurface the femoral hip joint and reconstitute function following the degenerative effects of osteo and rheumatoid arthritis. post trauma disease effects, avascular necrosis and septic total hip revision. The femoral stems are manufactured from cobalt chrome alloy. The cobalt chrome plasma spray coating provides an increased surface roughness to act as key for mechanical interlock with PMMA bone cement. The stem devices may be used with any one of a range of previously cleared Corin cobalt chrome modular heads, bipolar or uni-polar modular devices. The C-Fit plasma sprayed femoral components are intended for use with bone cement only.
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
femoral hip joint
Indicated Patient Age Range
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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
This submission is supported by extensive mechanical test data confirming the device's safety and effectiveness. The device has been in clinical use outside the U.S. for approximately ten years and no significant post-operative problems have been reported.
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Page 8 5019 510(k) SUMMARY
MAR 2 5 1997
Name of Company: Corin Medical Ltd. The Corinium Centre Cirencester Gloucestershire GL7 1 YJ United Kingdom
Name of Device: The C-Fit Femoral Hip System
Device Description: A femoral hip system consisting of standard and long stem options with or without calcar collars, plasma sprayed either proximally or five eighths of stem and for use with or without a PMMA cement centralizer. The devices are used to resurface the femoral hip joint and reconstitute function following the degenerative effects of osteo and rheumatoid arthritis. post trauma disease effects, avascular necrosis and septic total hip revision. The femoral stems are manufactured from cobalt chrome alloy. The cobalt chrome plasma spray coating provides an increased surface roughness to act as key for mechanical interlock with PMMA bone cement. The stem devices may be used with any one of a range of previously cleared Corin cobalt chrome modular heads, bipolar or uni-polar modular devices. The C-Fit plasma sprayed femoral components are intended for use with bone cement only.
SUMMARY OF SUBSTANTIAL EQUIVALENCE AND SAFETY AND EFFECTIVENESS
The C-Fit Femoral Hip system is a modification of the previously cleared V.S.P. (now called C-Fit stem) Hip system, manufactured by Corin Medical Ltd. The original V.S.P. (now called C-Fit stem) stem is manufactured from titanium alloy with a cobalt chrome plasma spray coating applied. This submission extends the range to include a cobalt chrome stem with cobalt chrome plasma spray coating and long stem options. The C-Fit cobalt chrome stem without coating is previously cleared for sale for use with cement. Corin, additionally, claims substantial equivelence to the Mallory/head system from Biomet, with the specific reference to plasma sprayed long femoral stems.
This submission is supported by extensive mechanical test data confirming the device's safety and effectiveness. The device has been in clinical use outside the U.S. for approximately ten years and no significant post-operative problems have been reported.