(85 days)
No
The 510(k) summary describes a mechanical hip resurfacing system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a hip implant, not a therapeutic device. It replaces a part of the body rather than treating a disease or condition therapeutically.
No
This device is a hip implant, specifically a femoral component for hip resurfacing arthroplasty, and is used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a "femoral component" which is a physical implant, not software.
Based on the provided text, 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this is a "Durom® Hip Resurfacing System femoral component," which is a physical implant designed to replace part of the hip joint.
- Intended Use: The intended use describes a surgical procedure (hemi-hip resurfacing arthroplasty) to treat conditions affecting the hip joint. It does not involve testing samples from the body.
- Anatomical Site: The anatomical site is the hip joint, femoral head, and acetabulum, which are parts of the musculoskeletal system, not biological samples for testing.
The device is a surgical implant, not a diagnostic tool used outside the body on biological samples.
N/A
Intended Use / Indications for Use
FOR HEMI-HIP RESURFACING ARTHROPLASTY:
The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and where acetabular replacement is neither required nor desirable. Such patients will generally be under the age of 65.
- Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis if remaining bone stock is adequate, and osteoarthritis
- Inflammatory joint disease (IJD), e.g. rheumatoid arthritis
- Joint replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives
Additional indications include other abnormalities where major pathology affects the femoral head; where the bearing surface and supportive bone structure of the acetabulum is normal; and where acetabular replacement is neither required nor desirable
- WARNING: The Durom Femoral component is not approved for use with the Durom Acetabular cup for total hip surface replacement arthroplasty in the USA.
Product codes
KXA
Device Description
The Durom® Hip Resurfacing System femoral component consists of a monoblock head and slim-line femoral guide pin. The head is an extended hemisphere (greater than 180°). It is available in 12 sizes with Outside Diameters (ODs) ranging from 38mm to 60mm. The spherecity of the head is tightly controlled to less than 10 microns. The underside of the head has recesses for controlled pressurization of cement into the cancellous bone, and for rotational stability after implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head, acetabulum, hip joint
Indicated Patient Age Range
generally be under the age of 65
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
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
Key Metrics
Not Found
Predicate Device(s)
K021799, K032659, K043542, K994153
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K070292 Pg 1 of 3
Summary of Safety and Effectiveness
. . .
APR 2 6 2007
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony Francalancia, RAC
Senior Associate, Regulatory Affairs
Telephone: (574) 372-4570
Fax: (574) 372-4605 |
| Date: | April 9, 2007 |
| Trade Name: | Durom® Hip Resurfacing System, Femoral
Components |
| Common Name: | Prosthesis, hip, femoral, resurfacing |
| Classification Name
and Reference | Hip joint femoral (hemi-hip) metallic resurfacing
prosthesis 21 CFR § 888.3400 |
| Device Product Code and Panel Code: | Orthopedics/87/KXA |
| Predicate Devices: | Cemented Femoral Head Resurfacing Device,
manufactured by Biomet Orthopedics, K021799,
cleared June 26, 2002.
DePuy ASRTM Resurfacing Femoral Heads,
manufactured by DePuy Orthopaedics, K032659,
cleared December 4, 2003.
BIOPRO TARA Femoral Resurfacing Component,
manufactured by BioPro, Inc., K043542, cleared
May 18, 2005.
The Cormet 2000 Hemi Hip Metallic Resurfacing
Prostheses, manufactured by Corin Medical,
K994153, cleared February 25, 2000. |
| Device Description: | The Durom® Hip Resurfacing System femoral
component consists of a monoblock head and slim-
line femoral guide pin. The head is an extended
hemisphere (greater than 180°). It is available in 12
sizes with Outside Diameters (ODs) ranging from
38mm to 60mm. The spherecity of the head is
tightly controlled to less than 10 microns. The |
1
underside of the head has recesses for controlled pressurization of cement into the cancellous bone, and for rotational stability after implantation.
V 070247
Intended Use:
FOR HEMI-HIP RESURFACING ARTHROPLASTY:
The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and where acetabular replacement is neither required nor desirable. Such patients will generally be under the age of 65.
- . Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis if remaining bone stock is adequate, and osteoarthritis
- . Inflammatory joint disease (IJD), e.g. rheumatoid arthritis
- . Joint replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives
Additional indications include other abnormalities where major pathology affects the femoral head: where the bearing surface and supportive bone structure of the acetabulum is normal; and where acetabular replacement is neither required nor desirable
- WARNING: The Durom Femoral component is not approved for use with the Durom Acetabular cup for total hip surface replacement arthroplasty in the USA.
The femoral components of the Durom® Hip Resurfacing System have the same intended use,
Comparison to Predicate Device:
2
ROTOATI py 2 of 3
similar performance characteristics, are made of the same material and are similar in design to the predicate devices.
Performance Data (Non-clinical)
:
. . . .
The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Mr. Anthony Francalancia P.O. Box 708 Warsaw, Indiana 46581-4605
APR 2 6 2007
Re: K070292 Trade/Device Name: Durom® Hip Resurfacing System, femoral components Regulation Number: 21 CFR 888.3400 Regulation Name: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis Regulatory Class: II Product Code: KXA Dated: March 20, 2007 Received: March 21, 2007
Dear Mr. Francalancia:
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
4
(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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): ¥ 070297
Device Name:
Durom® Hip Resurfacing System, femoral components
Indications for Use:
FOR HEMI-HIP RESURFACING ARTHROPLASTY:
The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and where acetabular replacement is neither required nor desirable. Such patients will generally be under the age of 65.
- Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis if . remaining bone stock is adequate, and osteoarthritis
- . Inflammatory joint disease (IJD), e.g. rheumatoid arthritis
- Joint replacements may be considered for younger patients if any unequivocal . indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives
Additional indications include other abnormalities where major pathology affects the femoral head; where the bearing surface and supportive bone structure of the acetabulum is normal; and where acetabular replacement is neither required nor desirable
* WARNING: The Durom Femoral component is not approved for use with the Durom Acetabular cup for total hip surface replacement arthroplasty in the USA.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
**(Division Sign-Off)**Page 1 of 1
Division of General, Restorative,
and Neurological Devices
510(k) Number K070292
0007