(36 days)
Not Found
No
The summary describes a mechanical hip prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hip prosthesis, which is a medical implant designed to treat severe hip pain and disability, thus performing a therapeutic function.
No
The device is a hip prosthesis, which is an implant used to replace a damaged hip joint, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a "one-piece straight, collarless and highly polished femoral stem," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for treating hip conditions. This involves direct intervention within the body, not testing samples outside the body.
- Device Description: The device is described as a "femoral stem" intended for "cemented fixation into the intramedullary canal." This is a description of a physical implant used in surgery.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing conditions by examining samples in vitro (outside the living organism).
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic implant used to replace or support a damaged hip joint.
N/A
Intended Use / Indications for Use
The CPT® 12/14 Hip Prostheses are indicated for use with patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis. traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur and in the presence of proximal femoral bone defects; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.
Product codes
JDI
Device Description
The CPT® 12/14, like its predicate, is a one-piece straight, collarless and highly polished femoral stem that is intended to be used for cemented fixation into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur and/or acetabulum, femoral head, hip
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
Non-clinical performance testing demonstrated that the modified devices are equivalent to the predicate.
Key Metrics
Not Found
Predicate Device(s)
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/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold "Z" enclosed in a circle on the left, followed by the word "zimmer" in a smaller, lowercase font on the right. The logo is black and white.
030265
page 1 of 2
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 | MAR 0 4 2003 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Dalene T. Binkley, RAC
Associate, Regulatory Affairs
Telephone: (574) 372-4907
Fax: (574) 372-4605 | |
| Date: | January 21, 2003 | |
| Trade Name: | CPT® 12/14 Hip Prostheses | |
| Common Name: | Total hip prosthesis | |
| Classification Name and Reference: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,
Cemented | |
| | 21 CFR § 888.3350 | |
| Predicate Device: | Collarless Polished Taper and Collarless Polished
Taper LS Hip Prostheses, manufactured by Zimmer,
K960658, cleared July 16, 1996. | |
| Device Description: | The CPT® 12/14, like its predicate, is a one-piece
straight, collarless and highly polished femoral stem
that is intended to be used for cemented fixation
into the intramedullary canal for pathological or
degenerative conditions involving the femur and/or
acetabulum | |
| Intended Use: | The CPT® 12/14 Hip Prostheses are indicated for
use with patients suffering from severe hip pain and
disability due to rheumatoid arthritis, osteoarthritis.
traumatic arthritis, polyarthritis, collagen disorders,
avascular necrosis of the femoral head, and
nonunion of previous fractures of the femur and in
the presence of proximal femoral bone defects;
patients with congenital hip dysplasia, protrusio
acetabuli, or slipped capital femoral epiphysis;
patients suffering from disability due to previous | |
1
Image /page/1/Picture/0 description: The image shows the Zimmer logo. The logo consists of a large, stylized letter "Z" inside of a circle on the left, followed by the word "zimmer" in a smaller, sans-serif font on the right. The letter "Z" is bold and black, contrasting with the white background of the circle.
fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.
Comparison to Predicate Device: The modifications to the Collarless Polished Taper and Collarless Polished Taper LS Hip Prostheses change neither the intended use nor the fundamental scientific technology of the device. It is packaged and sterilized using the same materials and processes. The modified device was created to offer a line extension to provide the surgeon with more options. Performance Data: Non-clinical performance testing demonstrated that the modified devices are equivalent to the predicate.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three horizontal lines above them, possibly representing the concept of health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 4 2003
Ms. Dalene T. Binkley Regulatory Affairs Associate Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K030265
Trade/Device Name: CPT 12/14 Hip Prostheses Regulation Numbers: 21 CFR 888.3350 Regulation Names: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: February 18, 2003 Received: February 19, 2003
Dear Ms. Binkley:
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.
3
Page 2 - Ms. Dalene T. Binkley
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. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Milkersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Page 1 of 1
510(k) Number (if known):
Device Name:
CPT® 12/14 Hip Prosthesis
Indications for Use:
The CPT® 12/14 Hip Prostheses are indicated for use with patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur and in the presence of proximal femoral bone defects; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the affected extremity; and patients with acute femoral neck fractures.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark H. Millkeun
Division Sign-Off
Division of Cere
and Neurologics
| 510(k) Num | K030265 |
|---|---|
| ------------ | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|