(242 days)
The indications for the Corin MetaFix Hip as a total hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:
• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union and femoral neck fractures
• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The MetaFix Hip is intended for cementless use only.
The Metafix Hip is a tapered stem manufactured from titanium (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The Metafix™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collarless), a 125° standard offset (collared and collarless), a 125° short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads.
This is a 510(k) premarket notification for a medical device called the Corin MetaFix Hip Stem, not an AI/ML device. Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly regarding AI performance, is not applicable.
The document states:
- "Clinical testing was not necessary in this Traditional 510(k)." (Page 4, Section 13)
- The submission is primarily to "modify the labeling to remove an indications for use for the MetaFix Hip Stem, for clarity to ensure safe or effective use." (Page 4)
- The device design and compatible components are "identical to that of the predicate device" (K082525, K120362, K121439, K130634, K131952 and K153381). (Page 4)
- The substantial equivalence is based on similarities in "design, materials, coating, sizes and similar in terms of intended use/indications for use." (Page 4, Section 11)
Therefore, the information for establishing acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details as they relate to an AI/ML device's performance are not provided in this document. The FDA's review concluded substantial equivalence based on non-clinical data and comparison to predicate devices, which is typical for traditional 510(k) submissions of non-AI devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2017
Corin USA Rachel King Regulatory Affairs Associate 5670 W. Cypress Street Suite C Tampa, Florida 33607
Re: K162942 Trade/Device Name: Corin MetaFix Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, KWL, KWY, JDI, MEH, OQI Dated: May 30, 2017 Received: Mav 31, 2017
Dear Ms. King:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| Indications for Use | |
| 510(k) Number ( if known )K162942 | |
| Device NameCorin Metafix Hip Stem | |
| Indications for Use ( Describe )The indications for the Corin MetaFix Hip as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemi-arthroplasty, include: | |
| • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis• Rheumatoid arthritis• Correction of functional deformity• Treatment of non-union and femoral neck fractures• Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) | |
| The MetaFix Hip is intended for cementless use only. | |
| Type of Use (Select one or both, as applicable)☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995.DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." | |
| FORM FDA 3881 (8/14)Page 1 of 1 |
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| 3. 510(K) SUMMARY | |||
|---|---|---|---|
| 1. Applicant/Sponsor: | Corin USA | ||
| Distributor | 5670 W. Cypress Street | ||
| Suite C | |||
| Tampa, Florida 33607 | |||
| Establishment Registration No.: 1056629 | |||
| 2. Contact Person: | Rachel King, BSc (Hons) | ||
| Regulatory Affairs Associate | |||
| Corin Ltd | |||
| +44 1285 884733 | |||
| rachel.king@coringroup.com | |||
| Lucinda Gerber, BA (Hons) | |||
| Global Regulatory Affairs Manager | |||
| Corin Ltd / Corin USA | |||
| 1 (772) 321-2478 | |||
| lucinda.gerber@coringroup.com | |||
| 3. Date: | October 19, 2016 | ||
| 4. Proprietary Name: | Corin MetaFix Hip Stem | ||
| 5. Common Name: | Hip Prosthesis | ||
| 6. Product Code(s): | LZO, KWL, KWY, JDI, MEH, OQI | ||
| 7. Classification Name: | 21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis |
- 21 CFR 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
- 21 CFR 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
- 21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis
8. Legally Marketed Devices to which Substantial Equivalence is claimed:
9. Device Description:
The Metafix Hip is a tapered stem manufactured from titanium (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The Metafix™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collarless), a 125° standard offset (collared and collarless), a 125° short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads.
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K162942
The Metafix hip is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The Corin MetaFix Hip Stem was originally cleared in K082525, K120362, K121439, K130634, K131952 and K153381. The purpose of this submission is to modify the labeling to remove an indications for use for the MetaFix Hip Stem, for clarity to ensure safe or effective use. The design and compatible components for use with the Corin MetaFix Hip stem subject of this submission are identical to that of the predicate device K082525, K120362, K121439, K130634, K131952 and K153381.
10. Intended Use / Indications:
The indications for the Corin MetaFix Hip arthroplasty, and when used in combination with a Corin hemi arthroplasty head, as a hip hemi-arthroplasty, include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- . Rheumatoid arthritis
- . Correction of functional deformity
- . Treatment of non-union and femoral neck fractures
- . Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin MetaFix Hip is intended for cementless use only.
11. Summary of Technologies / Substantial Equivalence:
The MetaFix Hip Stem subject of this submission is identical to the predicate MetaFix Hip Stem (K082525, K120362, K121439, K130634, K131952 and K153381) in design, materials, coating, sizes and similar in terms of intended use/indications for use. Based on these similarities, Corin believes that the MetaFix Hip Stem is substantially equivalent to the predicate device.
12. Non-Clinical Testing:
A comparison of indications for use and contraindications demonstrate substantial equivalence. Bacterial Endotoxin Testing (BET) has been conducted on finished product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology.
13. Clinical Testing:
Clinical testing was not necessary in this Traditional 510(k).
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.