(159 days)
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No
The document describes a mechanical hip replacement system and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is a total hip system indicated for the treatment of severely disabled hip joints, which directly addresses a medical condition and aims to restore function, meeting the definition of a therapeutic device.
No
Explanation: This device is a total hip replacement system, indicated for the treatment of severe hip joint disabilities. It is a prosthetic device used for treatment, not for diagnosing conditions.
No
The device description clearly states it consists of physical components like femoral stems, modular femoral heads, and acetabular components, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of severely disabled hip joints and revision of previous hip surgeries. This describes a surgical implant used in vivo (within the body) to replace a joint.
- Device Description: The description details components like femoral stems, modular femoral heads, and acetabular components, which are all physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The SC Total Hip System is indicated for use in the treatment of severcly disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.
The SC Femoral Hip Stem is indicated for use with or without bonc cement.
The SC Acetabular Cup is for use with bone cement only.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LWJ
Device Description
The SC Total Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The femoral stems are straight, non-porous collarless designs in standard and lateralized configurations. Revision lengths are also available. The acctabular components are UHMWPE, in various diameters, with various offset options.
Materials: The devices are manufactured from Ti6Al-7Nb Titanium alloy, CoCrMo alloy and Ultra High Molecular Weight Polyethylene ( UHMWPE ) per ASTM and ISO standards.
Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.
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
hip joints
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
SL-Plus Hip Stem ( Plus Orthopedics ), Zweymuller SL Hip System ( AlloPro ), Lester Press Fit Hip System ( Kirschner ), Alloclassic Zweymuller SL Hip Stem ( Sulzer Medica )
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
OCT 1 5 2003
Summary of Safety and Effectiveness for the SC Total Hip System
This safety and effectiveness summary for the SC Total Hip System is provided per Section 513(i)(3) of the Food, Drug and Cosmetic Act
l. Submitter : Orthopedic Alliance LLC 41558 Eastman Drive Suite A Marietta, CA 92562
Contact Person : Roger Williams Orthopedic Alliance LLC 41558 Eastman Drive Suite A Marietta, CA 92562 Telephone: ( 909 ) 304-9001
Date Prepared: May 3, 2003
- Tradename: SC Total Hip System Common Name: Total Hip System Classification Name: Hip joint metal /polymer semi-constrained cemented prosthesis ( 888.3350 )
3. Predicate or legally marketed devices which are substantially equivalent :
- SL-Plus Hip Stem ( Plus Orthopedics )
- Zweymuller SL Hip System ( AlloPro ) ●
- Lester Press Fit Hip System ( Kirschner ) ●
- Alloclassic Zweymuller SL Hip Stem ( Sulzer Medica ) ●
4. Description of the device :
The SC Total Hip System is a total hip system used for the replacement of severely disabled hip joints. It consists of femoral stems, modular femoral heads and acetabular components. The femoral stems are straight, non-porous collarless designs in standard and lateralized configurations. Revision lengths are also available. The acctabular components are UHMWPE, in various diameters, with various offset options.
Materials: The devices are manufactured from Ti6Al-7Nb Titanium alloy, CoCrMo alloy and Ultra High Molecular Weight Polyethylene ( UHMWPE ) per ASTM and ISO standards.
Function: The system functions to provide pain relief and improved function to the hip that has been disabled from arthritic conditions or trauma.
5. Intended Use:
The SC Total Hip System is indicated for use in the treatment of severely disabled hip joints resulting from painful osteo-, rheumatoid, and post-traumatic arthritis, and the late stages of avascular necrosis, and for the revision of previous hip surgeries.
The SC Femoral Hip Stern is indicated for use with or without bone cement. The SC Acctabular Cup is for use with bone cement only.
- Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the SC Total Hip System and other total hip systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials and intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal are three stylized human profiles facing to the right, with flowing lines above them.
Public Health Service
OCT 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger Williams Orthopedic Alliance LLC 41558 Eastman Drive, Suite A Marietta, CA 92562
Re: K031474 Trade/Device Name: SC Total Hip System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI, LWJ Dated: September 17, 2003 Received: September 22, 2003
Dear Mr. Williams:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Roger Williams
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millen
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page I of 1
510(k) Number ( if known ) : K031474
Device Name : SC Total Hip System
Indications For Use :
The SC Total Hip System is indicated for use in the treatment of severcly disabled hip joints resulting from painful osteo-, rheumatoid and post-traumatic arthritis, and the late stages of avascular necrosis, and for revision of previous hip surgeries.
The SC Femoral Hip Stem is indicated for use with or without bonc cement.
The SC Acetabular Cup is for use with bone cement only.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation ( ODE )
Prescription use ( PER 21 CFR 801.109)
OR
Over-the-counter use _________________________________________________________________________________________________________________________________________________________
( optional format 1-2-96 )
Mark N. Milliman
vision Sign-Of Restorative and Neurologic
510(k) Number K031474 mna