(91 days)
Not Found
No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The submission is for a labeling change to a previously cleared device.
Yes
The device is described as "total hip arthroplasty" and "hip hemi-arthroplasty" intended to "provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation". These uses clearly fall under the definition of a therapeutic device.
No
The device description clearly states it is a hip implant ("total hip arthroplasty," "hip hemi-arthroplasty," and "replaces the damaged hip joint articulation"). It is designed to physically replace a joint, not to diagnose a condition. Its indications for use are conditions that lead to hip replacement, not conditions it diagnoses.
No
The device description clearly states it is a physical implant (hip stem) made of titanium alloy with coatings, intended for surgical implantation. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the Corin TriFit TS Hip is a hip stem, a physical implant designed to replace a damaged hip joint. It is a surgical implant, not a device used for testing biological samples.
- Intended Use: The intended uses listed are all related to replacing a damaged hip joint due to various conditions affecting the joint itself. None of the indications involve testing or analyzing biological samples.
Therefore, the Corin TriFit TS Hip is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indications for the Corin TriFit TS 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 TriFit TS Hip is intended for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LZO, KWL, KWY
Device Description
The Corin TriFit TS Hip is a double tapered-wedge blade stem design manufactured from Ti6Al4V Titanium alloy (ASTM F-136-08) with a layer of commercially pure titanium (BS ISO 5832-2: 1999) and calcium phosphate (BONIT®) coating (ASTM F1609-08) applied. The TriFit TS Hip is available in 11 sizes in standard and lateralized offsets with a 127° CCD angle. The device is intended to be used with Corin 12/14 modular taper heads.
The TriFit TS 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 TriFit TS Hip Stem was originally cleared in K121563. The purpose of this submission is to modify the labeling to remove an indications for use for the TriFit TS Hip Stem, for clarity to ensure safe or effective use. The design and compatible components for use with the Corin TriFit TS Hip stem subject of this submission are identical to that of the predicate device K121563.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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: A comparison of indications for use and contraindications demonstrate substantial equivalence.
Clinical Testing: Clinical testing was not necessary in this Traditional 510(k).
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.
March 31, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Corin USA Limited Ms. Diana L. Nader-Martone Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607
Re: K153772 Trade/Device Name: Corin TriFit TS Hip 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: MEH, LZO, KWL, KWY Dated: December 30, 2015 Received: December 31, 2015
Dear Ms. Nader-Martone:
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
1
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/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153772
Device Name Corin TriFit TS Hip
Indications for Use (Describe)
The indications for the Corin TriFit TS 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 TriFit TS 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)
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| 1. Applicant/Sponsor: | Corin USA |
|---|---|
| Distributor | 5670 W. Cypress Street |
| Suite C | |
| Tampa, Florida 33607 | |
| Establishment Registration No.: 1056629 | |
| 2. Contact Person: | Diana L. Nader-Martone |
| Regulatory Affairs Associate | |
| Corin USA | |
| 813-977-4469 | |
| diana.nader-martone@coringroup.com | |
| Kathy Trier | |
| VP Global Regulatory and Clinical Affairs | |
| Corin USA | |
| 813-977-4469 | |
| kathy.trier@coringroup.com | |
| 3. Date: | March 30, 2016 |
| 4. Proprietary Name: | Corin TriFit TS Hip |
| 5. Common Name: | Hip Prosthesis |
| 6. Product Code(s): | MEH, LZO, KWL, KWY |
7. Classification Name:
21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
21CFR 888.3360 – Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21CFR 888.3390 - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
-
- Legally Marketed Devices to which Substantial Equivalence is claimed:
- Corin TriFit TS Hip Stem (K121563) .
4
9. Device Description:
The Corin TriFit TS Hip is a double tapered-wedge blade stem design manufactured from Ti6Al4V Titanium alloy (ASTM F-136-08) with a layer of commercially pure titanium (BS ISO 5832-2: 1999) and calcium phosphate (BONIT®) coating (ASTM F1609-08) applied. The TriFit TS Hip is available in 11 sizes in standard and lateralized offsets with a 127° CCD angle. The device is intended to be used with Corin 12/14 modular taper heads.
The TriFit TS 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 TriFit TS Hip Stem was originally cleared in K121563. The purpose of this submission is to modify the labeling to remove an indications for use for the TriFit TS Hip Stem, for clarity to ensure safe or effective use. The design and compatible components for use with the Corin TriFit TS Hip stem subject of this submission are identical to that of the predicate device K121563.
10. Intended Use / Indications:
The indications for the Corin TriFit TS 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 TriFit TS Hip is intended for cementless use only.
11. Summary of Technologies / Substantial Equivalence:
The TriFit TS Hip Stem subject of this submission is identical to the predicate TriFit TS Hip Stem (K121563) in design, materials, coating, sizes and similar in terms of intended use/indications for use. Based on these similarities, Corin believes that the TriFit TS Hip Stem is substantially equivalent to the predicate device.
12. Non-Clinical Testing:
A comparison of indications for use and contraindications demonstrate substantial equivalence
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13. Clinical Testing:
Clinical testing was not necessary in this Traditional 510(k).