(268 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is indicated for hemi hip resurfacing arthroplasty to relieve pain and disability and restore hip function in patients with degenerative joint disease. These are therapeutic objectives.
No
This device is a surgical implant designed to replace a portion of the femoral head in hip resurfacing arthroplasty, which is a treatment, not a diagnostic procedure.
No
The device description clearly states it is a physical component manufactured from metal alloy, designed to replace the outer surface of the femoral head.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Cormet Cementless Resurfacing Femoral Head is a surgical implant designed to replace the outer surface of the natural femoral head in hip resurfacing arthroplasty. It is a physical device implanted into the body.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is purely therapeutic and structural.
Therefore, the Cormet Cementless Resurfacing Femoral Head falls under the category of a medical device (specifically, a surgical implant), but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cormet Cementless Resurfacing Femoral Head is indicated for hemi hip resurfacing arthroplasty in patients with non-inflammatory degenerative joint disease, including osteo and rheumatoid arthritis, post traumatic disease and avascular necrosis.
It is indicated for relief of pain and disability, and to restore hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal.
It is intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as:
- previously failed femoral osteotomy, .
- early deformities of the proximal end of the femur. .
The Cormet Cementless Resurfacing Femoral Head is indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
KXA
Device Description
The Cormet Cementless Resurfacing Femoral Head is a femoral component manufactured from cast cobalt-chromium-molybdenum (Co-Cr-Mo) alloy complying with the requirements of ASTM F75 and ISO 5832-4. It is designed to replace the outer surface of the natural femoral head for hemi hip arthroplasty and articulates against the natural acetabulum. The component has a central stem and three internal splines to provide anti-rotational stability. The inner, bone contacting surfaces of the component have coatings of plasma sprayed titanium and hydroxyapatite for cementless fixation. The Cormet Cementless Resurfacing Femoral Head is not approved for use with an acetabular component in the US.
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)
Non-clinical testing submitted to support a determination of substantial equivalence was based on coating characterization. The coating applied to the Cormet Cementless Resurfacing Femoral Head consisting of plasma sprayed titanium and hydroxyapatite was characterized and cleared under K083312 (Corin MiniHip Stem). No additional bench testing was required since the cemented version of the device is a legally marketed predicate device. Clinical testing was not necessary to determine substantial equivalence between the Cormet Cementless Resurfacing Femoral Head and the predicate devices.
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
: | | | |
3. 510(K) SUMMARY
| 1. Applicant/Sponsor: | Corin USA
10500 University Center Drive
Suite 190
Tampa, Florida 33612
Establishment Registration No.: |
|-------------------------|--------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Ashlea Bowen
Regulatory Affairs Associate
Corin USA
813-977-4469
ashlea.bowen@coringroup.com |
| 3. Date of Preparation: | April 15, 2010 |
| 4. Proprietary Name: | Cormet Cementless Resurfacing Femoral Head |
| 5. Common Name: | Hemi hip resurfacing femoral component |
| 6. Classification Name: | Hip joint femoral (hemi-hip) metallic resurfacing prosthesis
(21CFR 888.3400) |
- Legally Marketed Devices to which Substantial Equivalence is claimed:
a. Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis (K994153)
b. ReCap® HA Press-Fit Femoral Resurfacing Head (K071053)
8. Device Description:
The Cormet Cementless Resurfacing Femoral Head is a femoral component manufactured from cast cobalt-chromium-molybdenum (Co-Cr-Mo) alloy complying with the requirements of ASTM F75 and ISO 5832-4. It is designed to replace the outer surface of the natural femoral head for hemi hip arthroplasty and articulates against the natural acetabulum. The component has a central stem and three internal splines to provide anti-rotational stability. The inner, bone contacting surfaces of the component have coatings of plasma sprayed titanium and hydroxyapatite for cementless fixation. The Cormet Cementless Resurfacing Femoral Head is not approved for use with an acetabular component in the US.
1
K092198 (pg. 20f3
-
- Intended Use / Indications:
The Cormet Cementless Resurfacing Femoral Head is indicated for hemi hip resurfacing arthroplasty in patients with non-inflammatory degenerative joint disease, including osteo and rheumatoid arthritis, post traumatic disease and avascular necrosis.
- Intended Use / Indications:
It is indicated for relief of pain and disability, and to restore hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal.
It is intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as:
- previously failed femoral osteotomy, .
- early deformities of the proximal end of the femur. .
The Cormet Cementless Resurfacing Femoral Head is indicated for cementless use only
10. Summary of Technologies/Substantial Equivalence:
The Cormet Cementless Resurfacing Femoral Head is geometrically identical to and has identical bearing surface characteristics as the predicate Cormet 2000 Hemi Hip Resurfacing device (K994153) with the addition of 4 more sizes included within the range of the currently cleared device. It has the same indications for use, is similar in design, and manufactured from the same materials, surface finishing, and processing as the predicate device the Biomet ReCap® HA Press-Fit Femoral Resurfacing Head (K071053). Based on these similarities, Corin believes that the Cormet Cementless Resurfacing Femoral Head is substantially equivalent to the predicate devices.
11. Non-Clinical Testing:
Non-clinical testing submitted to support a determination of substantial equivalence was based on coating characterization. The coating applied to the Cormet Cementless Resurfacing Femoral Head consisting of plasma sprayed titanium and hydroxyapatite was characterized and cleared under K083312 (Corin MiniHip Stem).
2
K092198 (pg. 3 of 3)
No additional bench testing was required since the cemented version of the device is a legally marketed predicate device.
-
- Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Cormet Cementless Resurfacing Femoral Head and the predicate devices.
- Clinical Testing:
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Corin USA % Ms. Ashlea Bowen Regulatory Affairs Associate 10500 University Center Drive, Suite 190 Tampa, Florida 33612
APR 1 5 2010
Re: K092198
Trade/Device Name: Cormet Cementless Resurfacing Femoral Head Regulation Number: 21 CFR 888.3400 Regulation Name: Hip joint metal femoral (hemi-hip) metallic resurfacing prosthesis Regulatory Class: II Product Code: KXA Dated: January 28, 2010 Received: January 29, 2010
Dear Ms. Bowen:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Ashlea Bowen
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark M. Millerm
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
2. INDICATIONS FOR USE
510(k) Number (if known): _K092/98
Device Name: Cormet Cementless Resurfacing Femoral Head
Indications for Use:
The Cormet Cementless Resurfacing Femoral Head is indicated for hemi hip resurfacing arthroplasty in patients with non-inflammatory degenerative joint disease, including osteo and theumatoid arthritis, post traumatic disease and avascular necrosis.
It is indicated for relief of pain and disability, and to restore hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal.
It is intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as:
- · previously failed femoral osteotomy, .
- · early deformities of the proximal end of the femur.
The Cormet Cementless Resurfacing Femoral Head is indicated for cementless use only.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonata for mxm
Division of Surgical, Orthop and Restorative Devices
Page 1 of 1
510(k) Number K092198