(98 days)
No
The document describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat severe pain and disability due to various conditions affecting the hips, such as osteoarthritis and rheumatoid arthritis, by replacing the femoral head's articular surface.
No
Explanation: The device is an implantable medical device used for partial hip replacement. It is designed to replace the articular surface of the femoral head and is not used to diagnose a condition or disease.
No
The device description clearly states it is a physical implant made of cobalt-chromium-molybdenum metal, designed for surgical implantation. It is a hardware device, not software.
Based on the provided information, the DePuy ASR™ Resurfacing Femoral Heads are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the DePuy ASR™ Resurfacing Femoral Heads are implants intended for surgical use in a partial hip replacement procedure (hemiarthroplasty). They are physically implanted into the patient's body to replace a damaged part of the bone.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the patient.
Therefore, this device falls under the category of a surgical implant or medical device used directly within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy ASR™ Resurfacing Femoral Heads are intended for cemented use in hemi-arthroplasty (partial hip replacement procedure). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acctabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.
Product codes (comma separated list FDA assigned to the subject device)
KXA
Device Description
The DePuy ASR™ Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a onepiece cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm to suit varying patient anatomy.
The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the ninimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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).
Not Found
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.
0
DEC - 4 2003
K032659 page 14
510(k) Summary
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
PO Box 988
700 Orthopaedics
Warsaw, IN 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Natalie Heck
Manager, Regulatory Affairs |
| TRADE NAME: | DePuy ASRTM Resurfacing Femoral Heads |
| COMMON NAME: | Resurfacing femoral head |
| CLASSIFICATION: | 888.3400: Hip joint femoral (hemi-hip) metallic
resurfacing prosthesis;
Class II |
| DEVICE PRODUCT CODE: | 87 KXA |
| SUBSTANTIALLY EQUIVALENT
DEVICES: | DePuy T.A.R.A Total Hip, K810325
Cemented Femoral Head Resurfacing Device
(Biomet Orthopaedics, Inc.) K021799 |
DEVICE DESCRIPTION:
The DePuy ASR™ Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a onepiece cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm to suit varying patient anatomy.
The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the ninimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum.
INDICATIONS FOR USE:
The DePuy ASR™ Resurfacing Femoral Heads are intended for cemented use in hemiarthroplasty (partial hip replacement procedure). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acctabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.
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pge 2 of 2
BASIIS OF SUBSTANTIAL EQUIVALENCE:
DePuy considers the DePuy ASR™ Resurfacing Femoral Heads to be substantially equivalent to
the femoral resurfacing heads submitted in the T.A.R.A. Total Hip Prosthesis, K.B.0 Biomet Cemented Femoral Resurfacing Head device, K. 1 Clair Homeons, Ruros22 And Inc. material composition, and intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 2003
Ms. Natalic Heck Manager, Regulatory Affairs DePuy Orthopedics, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw, Indiana 46581
Re: K032659
Trade/Device Name: Depuy ASR™ Resurfacing Femoral Heads Regulation Number: 21 CFR 888.3400 Regulation Name: Hip Joint Femoral (Hemi-hip) Metallic Resurfacing Prosthesis Regulatory Class: Class II Product Code: KXA Dated: August 27, 2003 Received: September 5, 2003
Dear Ms. Heck:
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
3
Page 2 - Ms. Natalie Heck
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. 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) 594-4639. 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 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 A. Millican
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
510(k) Number (if known): K6 3 > (3)
DePuy ASRTM Resurfacing Femoral Heads Device Name:
Indications for Use:
The DePuy ASR™ Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.
Concurrence of CDRH, Office of Device Evaluation
OR Prescription Use (Per 21 CFR/801.109)
Over-The-Counter Use
Mark N Millican
.ision Sign-Off) sion of General, Restorativ Ad Neurological Devices
K03 2659