(30 days)
No
The 510(k) summary describes a mechanical orthopedic implant (a modular femoral head) and its materials and dimensions. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical tests.
Yes, this device is a therapeutic device.
Explanation: The device is indicated for hemi-arthroplasty to address pain and disability due to conditions like osteoarthritis, rheumatoid arthritis, avascular necrosis, and femoral neck fracture, which are treatments meant to provide therapy for these conditions.
No.
The device description clearly states that the Corin Optimom Modular Head is a physical implant (a polished, truncated sphere with a high tolerance internal female taper) used in hemi-arthroplasty. It is a modification of an existing modular head for compatibility with femoral hip stem designs. Its intended use is to replace the femoral head in patients with various conditions affecting the hip, not to diagnose them.
No
The device description clearly states it is a physical implant (a polished, truncated sphere manufactured from Cobalt-Chrome alloy) intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for hemi-arthroplasty in surgical procedures to address pain and disability due to various conditions affecting the femoral head. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical implant made of Cobalt-Chrome alloy, designed to be surgically implanted as part of a hip replacement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
This device is a surgical implant used in orthopedic procedures.
N/A
Intended Use / Indications for Use
The Corin Optimom Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.
The device is intended for prescription use only.
Product codes
KWL
Device Description
The Corin Optimom Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is a device modification of the internal female taper of the Corin Unipolar Modular Heads (K063791) to provide for compatibility with an additional range of Corin femoral hip stem designs with a 12/14 male taper. The materials and dimensions of the internal female taper are substantially equivalent to the CoCr Modular Heads cleared in K003666 and K010243 and the Trinity Modular Heads cleared in K110087. The Optimom Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm with a variety of offsets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head, acetabular cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use only
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 conducted to demonstrate substantial equivalence includes a comparison of the designs, materials, intended use, indications and dimensions of the Corin Optimom Modular Head to the predicate devices Fatigue, rotational torque, axial pull off, and fretting corrosion were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented 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 component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
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AUG - 4 2011
| 3. 510(K) SUMMARY | |
|---|---|
| 1. Applicant/Sponsor: | Corin USA |
| 10500 University Center Drive | |
| Suite 190 | |
| Tampa, Florida 33612 | |
| Establishment Registration No.: 1056629 | |
| 2. Contact Person: | Lucinda Gerber |
| Regulatory Affairs Associate | |
| Corin USA | |
| 813-977-4469 | |
| lucinda.gerber@coringroup.com | |
| 3. Proprietary Name: | Corin Optimom Modular Head |
| 4. Common Name: | Optimom Modular Head |
| 5. Classification Name: | 21CFR 888.3360 - Hip joint femoral (hemi-hip) metal |
| cemented or uncemented prosthesis | |
| 6. Legally Marketed Devices to which Substantial Equivalence is claimed: | |
| • Corin Unipolar Modular Head (K063791) | |
| • Corin Taperfit Total Hip System (K003666) | |
| • Corin Tri-Fit Femoral Stem (K010243) |
- (K110087)
7. Device Description:
The Corin Optimom Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is a device modification of the internal female taper of the Corin Unipolar Modular Heads (K063791) to provide for compatibility with an additional range of Corin femoral hip stem designs with a 12/14 male taper. The materials and dimensions of the internal female taper are substantially equivalent to the CoCr Modular Heads cleared in K003666 and K010243 and the Trinity Modular Heads cleared in K110087. The Optimom Modular Head is manufactured from Cobalt-Chrome alloy conforming to
1
ASTM F75 and is available in diameters ranging from 40-56mm with a variety of offsets.
-
- Intended Use / Indications:
The Corin Optimom Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.
- Intended Use / Indications:
The device is intended for prescription use only.
-
- Summary of Technologies/Substantial Equivalence:
The Optimom Modular Heads have the same intended use and indications as the Corin Unipolar Modular Heads (K063791). The range of diameters available for the Optimom Modular Heads is within the range cleared for the predicate Unipolar Modular Heads and the device design is similar to the Unipolar Heads with the only modification of the internal female taper. The Optimom Modular Heads are manufactured from the same material as the predicates Unipolar Modular Heads, CoCr Modular Heads (K003666, K010243) and Trinity Modular Heads (K110087). The design and dimensions of the internal female taper of the Optimom Modular Heads are the same as the internal female taper of the predicates CoCr Modular Heads and Trinity CoCr Modular heads. Based upon these similarities, the Optimom Modular Heads are believed to be substantially equivalent to the predicate devices.
- Summary of Technologies/Substantial Equivalence:
10. Non-Clinical Testing:
Non-clinical testing conducted to demonstrate substantial equivalence includes a comparison of the designs, materials, intended use, indications and dimensions of the Corin Optimom Modular Head to the predicate devices Fatigue, rotational torque, axial pull off, and fretting corrosion were conducted.
-
- Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Corin Optimom Modular Heads and the predicate devices.
- Clinical Testing:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002
Corin USA % Ms. Lucinda Gerber Regulatory Affairs Associate 10500 University Center Drive. Suite 190 Tampa. Florida 33612
AUG - 4 2011
Re: K111911 Trade/Device Name: Corin Optimom Modular Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL Dated: July 01, 2011 Received: July 05, 2011
Dear Ms. Gerber:
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. 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
3
Page 2 - Ms. Lucinda Gerber
device-related adverse events) (21 CFR 803); 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.
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/CDRHOffices/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vour
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2. INDICATIONS FOR USE
510(k) Number (if known): _K1119 | |
Device Name: Corin Optimom Modular Head
Indications for Use:
The Corin Optimom Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, theumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.
The device is intended for prescription use only.
Prescription Use Over-The-Counter Use X - AND/OR (Part 21 CFR 801 Subpart D) (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)
Igor M. Melkersen