(59 days)
No
The 510(k) summary describes a mechanical hip stem implant and its intended use. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies focus on mechanical testing.
Yes
The device is a hip stem intended for use in total hip arthroplasty or hemi-arthroplasty to treat conditions like degenerative joint disease, rheumatoid arthritis, fractures, and congenital deformities, which directly addresses therapeutic intervention and restoration of function.
No
The device description and intended use indicate it is an implantable hip stem for arthroplasty, which is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical hip stem manufactured from titanium with a hydroxyapatite coating, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a hip stem, which is a surgical implant used in hip replacement surgery. It is a physical device implanted into the body, not a device used to test samples outside the body.
- Intended Use: The intended use clearly states it's for total hip arthroplasty and hemi-arthroplasty, which are surgical procedures to replace or partially replace the hip joint. This is a therapeutic intervention, not a diagnostic test.
The information provided about the device's material, design, and testing further confirms it is a medical device for surgical implantation, not an IVD.
N/A
Intended Use / Indications for Use
The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin Metafix Hip Stem is indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, OQI, MEH, KWL, KWY, JDI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral neck, proximal femur
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 and analysis included mechanical fatigue testing of the neck and stem and range of motion analysis. The results of this testing show that the Corin Metafix Collared Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
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
§ 888.3353 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized human figure with three faces in profile, representing the department's focus on health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2016
Corin USA Limited Ms. Rachel King Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607
Re: K153381 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, OQI, MEH, KWL, KWY, JDI Dated: November 20, 2015 Received: November 23, 2015
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 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/Resourcesfor You/Industry/default.htm. 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 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 yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153381
Device Name Corin Metafix Hip Stem Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Indications for Use (Describe)
The indications for the Corin Metalix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- · Rheumatoid arthritis
- · Correction of functional deformity
- · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
- · Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin Metafix Hip Stem is intended for cementless, single 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)
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| 1. Applicant/Sponsor: | Corin USA Limited 5670 W. Cypress Street Suite C Tampa Florida 33607 Registration No.: 1056629 |
|---|---|
| 2. Contact Person: | Rachel King, BSc (Hons) Regulatory Affairs Associate Corin Ltd +44 1285 884733 rachel.king@coringroup.com Kathy Trier Global VP Regulatory and Clinical Affairs Corin Ltd 813-977-4469 kathy.trier@coringroup.com |
| 3. Date: | November 19, 2015 |
| 4. Proprietary Name: | Corin Metafix Hip Stem |
| 5. Common Name: | Hip Prosthesis |
| 6. Product Codes: | LZO, KWL, KWY, JDI, OQI, MEH |
| 7. Classification Name: | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21CFR 888.3390) Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21CFR 888.3360) Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21CFR 888.3353) Hip joint metal/polymer semi-constrained cemented prosthesis. (21CFR 888.3350) |
510(K) SUMMARY 3.
Legally Marketed Devices to which Substantial Equivalence is claimed: 8.
- Corin Metafix Hip Stem (K082525, K121439 & K120362) ●
- Depuy Orthopaedics Corail AMT Hip System (K042992) .
- Corin TriFit TS Hip Stem (K121563)
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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.
10. Intended Use / Indications:
The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- . Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
- . Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin Metafix Hip Stem is indicated for cementless use only.
11. Summary of Technologies/Substantial Equivalence:
The Corin Metafix Collared Hip Stem has the same intended use and indications and is manufactured from the same materials as the predicates (K082525, K120362 & K121439). The Corin Metafix Collared Hip Stem has a tapered metaphyseal flare with proximal horizontal grooves, distal vertical grooves and medial calcar grooves similar to the predicate Corin Metafix Hip Stems.
The Corin Metafix Collared Hip Stem is similar to the DePuy Corail AMT Hip System (K042992) in that it has proximal horizontal grooves, a proximal collar, distal vertical grooves and medial calcar grooves.
The Corin Metafix Collared Hip Stem short neck variants are similar in design and measurements to the neck design of the Corin TriFit TS Hip Stem. Based on these similarities, Corin believes that the Metafix Collared Hip Stem is substantially equivalent to the predicate device.
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12. Non-Clinical Testing:
Non-clinical testing and analysis included mechanical fatigue testing of the neck and stem and range of motion analysis. The results of this testing show that the Corin Metafix Collared Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
13. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Corin Metafix Collared Hip Stem and the predicate devices.