(90 days)
Not Found
Not Found
No
The provided text describes a total hip replacement system and its indications for use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the physical components and their intended surgical application.
Yes
The device is a Modular Total Hip System, indicated for use in total or partial hip replacement to alleviate pain and disability caused by various hip joint conditions. This directly addresses health issues, making it a therapeutic device.
No
The provided text describes a "Modular Total Hip System" which is indicated for use in hip replacement procedures due to various hip joint conditions. This device is a prosthesis used for treatment, not for diagnosing a condition.
No
The device description and intended use clearly describe a physical implant (Total Hip System) used in surgical procedures, not a software application.
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 hip joint to address pain and disability caused by various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- No Mention of Diagnostic Activities: The provided text does not mention any activities related to examining specimens (like blood, tissue, or urine) outside of the body to diagnose a condition, which is the core function of an IVD.
An IVD is a medical device used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement. The R120™ [Modular Total Hip System] is used for relieving severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other applications. The Total Hip System is intended for use with and without bone cement.
Product codes
JDI, LPH
Device Description
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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 joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2001
Mr. Sam Son Vice President, Technical Affairs Osteoimplant Technology, Inc. 11201 Pepper Road Hunt Valley, Maryland 21031
Re: K011774
Trade/Device Name: R120™ Modular Total Hip System Regulation Number: 888.3050, 888.3358 Regulatory Class: II Product Code: JDI, LPH Dated: June 5, 2001 Received: June 7, 2001
Dear Mr. Son:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Sam Son
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Lisa Walker, MP
for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
2
KO11724 510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name: R120™ MODULAR TOTAL HIP SYSTEM
Indications For Use:
The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement The X120 - Northering sovere pain and disability due to structural damage in the hip joint from rheumatoid atthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other opplysis, that encation a. The Total Hip System is intended for use with and without bone cement.
(PLEASE DO NOT WRITE BRILOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Conourrence of CDRH, Office of Device Evaluation (ODF)
Lisa Walker, M.D.
(Division Sign-Off) Division of Goneral Restorative Devices 510(k) Number 1011
Proscription Use (Par 21 CFR 801.109) OR.
Over-The-Counter Uso _
(Optional Formal 1-2-96)