(85 days)
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 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.
The provided text describes the Zimmer Durom® Hip Resurfacing System's femoral components and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as typically found in studies for AI/software devices.
This document is a traditional 510(k) premarket notification for a physical medical device (a hip resurfacing system), not a software or AI device. Therefore, the types of performance data and study methodologies you're asking about (e.g., test sets, ground truth by experts, MRMC studies, standalone algorithm performance) are not applicable or present in this filing.
Instead, the "Performance Data (Non-clinical)" section briefly mentions:
"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective."
This statement implies that the device underwent engineering and biomechanical testing typical for orthopedic implants, such as fatigue testing, wear testing, material characterization, and possibly cadaveric studies or computational modeling, to ensure its structural integrity, biocompatibility, and mechanical performance under simulated physiological conditions. However, the specific details, results, and acceptance criteria for these tests are not included in this summary.
In summary, based only on the provided text, I cannot answer the questions as they pertain to a software or AI device's performance study. The document outlines the device's description, intended use, and substantial equivalence to predicate devices based on material, design, and similar performance characteristics evident from non-clinical laboratory testing.
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K070292 Pg 1 of 3
Summary of Safety and Effectiveness
. . .
APR 2 6 2007
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Anthony Francalancia, RACSenior Associate, Regulatory AffairsTelephone: (574) 372-4570Fax: (574) 372-4605 |
| Date: | April 9, 2007 |
| Trade Name: | Durom® Hip Resurfacing System, FemoralComponents |
| Common Name: | Prosthesis, hip, femoral, resurfacing |
| Classification Nameand Reference | Hip joint femoral (hemi-hip) metallic resurfacingprosthesis 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, clearedMay 18, 2005.The Cormet 2000 Hemi Hip Metallic ResurfacingProstheses, manufactured by Corin Medical,K994153, cleared February 25, 2000. |
| Device Description: | The Durom® Hip Resurfacing System femoralcomponent consists of a monoblock head and slim-line femoral guide pin. The head is an extendedhemisphere (greater than 180°). It is available in 12sizes with Outside Diameters (ODs) ranging from38mm to 60mm. The spherecity of the head istightly controlled to less than 10 microns. The |
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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:
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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.
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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
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(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
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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
§ 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.