(114 days)
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Trinity Acetabular System is intended for cementless, single use only.
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and BIOL.OX delta™ ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin utanium femoral stems.
The purpose of this submission is to add 28mm (-5mm offset), 32mm (-6mm offset), 36mm (-8mm offset), and 40mm (-8mm offset) CoCrMo extra short femoral heads to the Trinity Acetabular System, and complete the line of extra long heads with the addition of a 28mm (+7mm offset) CoCrMo heads.
This document describes the Corin Trinity Acetabular System with Extra short Heads and 28mm Extra long Head (K131647).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain explicit acceptance criteria in the traditional sense of performance metrics with specific thresholds (e.g., sensitivity, specificity, accuracy for an AI device). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices for new components being added to an existing system.
The "performance" demonstrated for these new components is primarily through non-clinical testing.
| Acceptance Criteria Category | Specific Criteria (Implicit from Substantial Equivalence Logic) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|---|
| Intended Use & Indications | Must be identical to or covered by predicate devices. | Identical to predicate devices (K093472, K110087, K130343) and similar to predicate devices (K993438, K003363, K042037). |
| Material Composition | Must be identical to predicate devices. | Identical to predicate devices (K093472, K110087, K130343, K993438, K003363, K042037). |
| Design & Sizes | Must be similar to predicate devices, ensuring compatibility and functionality within the existing system. | Similar to predicate devices in sizes and designs. |
| Performance (Mechanical) | Must demonstrate safe and effective mechanical performance, particularly regarding range of motion and fatigue, especially in worst-case scenarios. | Non-clinical testing conducted: impingement testing, range of motion testing, stem fatigue testing and stem neck fatigue testing with head offsets representing the worse-case scenario for compatible stems. |
2. Sample Size Used for the Test Set and Data Provenance
This submission pertains to the addition of new components (extra short and extra long femoral heads) to an existing hip prosthesis system. The evaluation relies on non-clinical testing (mechanical tests) rather than human clinical data. Therefore, the concepts of "test set" and "data provenance" as typically applied to AI/software performance studies are not directly applicable here. The "sample size" would refer to the number of physical components tested in the lab, but this detail is not provided in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is a medical device (hip prosthesis components) and the evaluation relies on non-clinical mechanical testing, there is no "ground truth" established by human experts in the context of diagnostic or interpretive performance. The "ground truth" for mechanical testing would be derived from engineering standards and test protocols.
4. Adjudication Method for the Test Set
Not applicable. Since the evaluation is based on non-clinical mechanical testing, an adjudication method for human interpretation is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This submission is for physical medical device components, not an AI or software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for physical medical device components, not an AI or software algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" would be established by engineering specifications, established test methods, and industry standards for mechanical performance of hip prosthesis components. For example, fatigue tests would have pre-defined failure criteria based on regulatory guidance or consensus standards.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this type of physical medical device submission, as it does not involve machine learning or data-driven model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set involved.
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K131647
| 3. | 510(K) SUMMARY |
|---|---|
| 1. Applicant/Sponsor: | Corin USA5670 West Cypress StreetSuite CTampa, Florida 33607Establishment Registration No.: 1056629 |
| 2. Contact Persons: | Diana L. MartoneRegulatory Affairs AssociateCorin USA813-977-4469diana.martone@coringroup.comKathy TrierVice President of Clinical and RegulatoryCorin USA813-977-4469kathy.trier@coringroup.comLucinda GerberRegulatory Affairs AssociateCorin USA813-977-4469lucinda.gerber@coringroup.com |
| 3. Proprietary Name: | Corin Trinity Acetabular System with Extra short Heads and 28mm Extra long Head |
- Common Name: Hip Prosthesis
-
- Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21CFR 888.3353) Product Codes: LZO, MEH
-
- Legally Marketed Devices to which Substantial Equivalence is claimed:
- Device Description:
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit,
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K131647
titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and BIOL.OX delta™ ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin utanium femoral stems.
The purpose of this submission is to add 28mm (-5mm offset), 32mm (-6mm offset), 36mm (-8mm offset), and 40mm (-8mm offset) CoCrMo extra short femoral heads to the Trinity Acetabular System, and complete the line of extra long heads with the addition of a 28mm (+7mm offset) CoCrMo heads.
The Trinity Acetabular System is intended for use in total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
-
- Intended Use / Indications:
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
- Intended Use / Indications:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular 0 necrosis
-
Rheumatoid arthritis 0
-
Correction of functional deformity 0
-
Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) 0
The Trinity Acctabular System is intended for cementless, single use only.
-
- Summary of Technologies/Substantial Equivalence:
The additional components of the Trinity Acetabular System are identical to the predicate devices (K093472, K1100087, K130343) in terms of intended use and indications, and materials, and similar in sizes, designs and performance. The additional components of the Trinity Acceabular System are identical to the predicate devices (K993438, K003363, K042037) in terms of materials, and similar in sizes, designs, performance, and intended use and indications. Based on these characteristics, the additional components of the Trinity Acetabular System are believed to be substantially equivalent to the predicate devices.
- Summary of Technologies/Substantial Equivalence:
-
- Non-Clinical Testing:
Non-clinical testing conducted to demonstrate substance includes: impingement testing, range of motion testing, and stem fatigue testing and stem neck fatigue testing with head offsets representing the worse-case scenario for the compatible stems.
- Non-Clinical Testing:
-
- Clinical Testing:
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Clinical testing was not necessary to determine substantial equivalence between the additional components of the Trinity Acetabular System and the predicate devices.
:
·
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Sentember 27, 2013
Corin USA Ms. Diana L. Martone Regulatory Affairs Associate 5670 West Cypress Street Suite C Tampa. Florida 33607
Re: K131647
Trade/Device Name: Trinity Acctabular System 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, MEH Dated: August 20, 2013 Received: August 21. 2013
Dear Ms. 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 cither 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
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Page 2 – Ms. Diana L. Martone
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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 yours, .
Erin | Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. INDICATIONS FOR USE
510(k) Number (if known): _K131647
Device Name: Trinity Acetabular System
Indications for Use:
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
- 0 Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 0 Rheumatoid arthritis
- o Correction of functional deformity
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) 0
The Trinity Acetabular System is intended for cementless, single use only.
X Prescription Use (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)
Elizabeth L. Frank -S
Page 1_ of 1
Division of Orthopedic Devices
§ 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.