(520 days)
No
The device description and performance studies focus on the mechanical properties and design of a hip stem, with no mention of AI or ML.
Yes
The device, a hip stem, is used to treat various medical conditions affecting the hip, such as degenerative joint disease, rheumatoid arthritis, and fractures, which aligns with the definition of a therapeutic device.
No
The device is a hip stem used for total hip arthroplasty, which is a treatment for various conditions, not a tool for diagnosing them.
No
The device description clearly states it is a physical hip stem made of titanium alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a Corin Metafix Hip Stem, which is a surgical implant used in total hip arthroplasty. It is a physical component implanted into the body to replace a damaged hip joint.
- Intended Use: The intended use clearly states it is for total hip arthroplasty to treat various conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for the Corin Metafix Hip Stem as a total hip arthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and o avascular necrosis
- Rheumatoid arthritis O
- Correction of functional deformity 0
- Treatment of non-union, femoral neck and trochanteric fractures of the o proximal femur
- DDH/CDH o
The Corin Metafix Hip Stem is indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI
Device Description
The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAI.V.) alloy for surgical implant applications, conforming to ASTM F136-2 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-88. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in 9 sizes (Size 2 to Size 10), each available in three lateral offsets including standard, lateralized, and Coxa Vara.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, 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 and analysis included mechanical fatigue testing, static tensile testing and range of motion testing. The results of this testing show that the Corin Metafix 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.
0
.082525
p-1/2
FEB - 4 2010
| 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, RAC | |
| Regulatory Affairs Associate | ||
| Corin USA | ||
| 813-977-4469 | ||
| ashlea.bowen@coringroup.com | ||
| 3. Proprietary Name: | Corin Metafix Hip Stem | |
| 4. Common Name: | Femoral Hip Stem | |
| 5. Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis (21CFR 888.3353) | ||
| Hip joint metal/polymer semi-constrained cemented prosthesis (21 | ||
| CFR 888.3350) | ||
| 6. Product Code: | LZO, JDI | |
| 7. Legally Marketed Devices to which Substantial Equivalence is claimed: |
a. Depuy Orthopaedics Corail AMT Hip System (K042992)
- Device Description:
The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAI.V.) alloy for surgical implant applications, conforming to ASTM F136-2 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-88. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in 9 sizes (Size 2 to Size 10), each available in three lateral offsets including standard, lateralized, and Coxa Vara.
- Intended Use / Indications:
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p. 2/2
The indications for the Corin Metafix Hip Stem as a total hip arthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and o avascular necrosis
- Rheumatoid arthritis O
- Correction of functional deformity 0
- Treatment of non-union, femoral neck and trochanteric fractures of the o proximal femur
- DDH/CDH o
The Corin Metafix Hip Stem is indicated for cementless use only.
-
- Summary of Technologies/Substantial Equivalence:
The Corin Metafix Hip Stem has the same intended use and indications and is manufactured from the same materials as the predicate. Additionally, the Corin Metafix Hip Stem has proximal horizontal grooves, distal vertical grooves and medial calcar grooves that are substantially equivalent to those found on the predicate device, the Depuy Corail AMT Hip System. Based on these similarities, Corin believes that the Metafix Hip Stem is substantially equivalent to the predicate device.
- Summary of Technologies/Substantial Equivalence:
-
- Non-Clinical Testing:
Non-clinical testing and analysis included mechanical fatigue testing, static tensile testing and range of motion testing. The results of this testing show that the Corin Metafix Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
- Non-Clinical Testing:
-
- Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Corin Metafix Hip Stem and the predicate device.
- Clinical Testing:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized human figure with outstretched arms, symbolizing care and protection. The overall design is simple and conveys a sense of authority and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Corin USA % Ms. Ashlea Bowen, RAC Regulatory Affairs Associate 10500 University Center Drive Suite 190 Tampa, Florida 33612
FEB - 4 2010
Re: K082525
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, JDI Dated: December 17, 2009 Received: December 18, 2009
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, 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
3
Page 2 - Ms. Ashlea Bowen, RAC
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 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/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.
Javarefneun
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): __________
Device Name: Corin Metafix Femoral Stem
Indications for Use:
The indications for the Corin Metafix Hip Stem as a total hip arthroplasty include:
- O Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- o Rheumatoid arthritis
- o Correction of functional deformity
- o Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
- DDH/CDH o
The Corin Metafix Hip Stem is indicated for cementless use only.
Prescription Use X (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)
Duta for mxm
(Division Sign-Or Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K082525