(255 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 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, ceramic and Co-Cr modular heads and titanium femoral stems.
The purpose of this submission is to add ECIMA acetabular liners to the Trinity Acetabular System. Corin's ECIMA is a cold irradiated, mechanically annealed, vitamin E blended ultra high molecular weight polyethylene.
The provided document is a 510(k) summary for the Corin Trinity Acetabular System ECIMA Liners. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical trial or a standalone algorithm performance study.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
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Acceptance Criteria/Device Performance: The document does not describe specific acceptance criteria for performance metrics in a clinical context. Instead, it relies on non-clinical testing to demonstrate performance in various aspects (tensile strength, impact strength, wear, etc.) and states that the new components are "similar to the predicate devices in terms of intended use and indications, materials, sizes, designs and performance." The implicit acceptance criterion is "substantial equivalence" to the predicate device based on these similarities and the non-clinical test results.
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Study Proving Acceptance Criteria Met: No clinical study is presented to prove the device meets acceptance criteria.
Let's address the specific points you asked for, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Clinical Efficacy/Safety | Not specified (no clinical study performed) | Not reported (no clinical study performed) |
| Material/Mechanical Properties | Implied to be similar to predicate device (K110087) based on non-clinical testing. | Non-clinical tests were performed for: tensile strength, impact strength, compressive strength, small punch strength, thermal properties, free radical concentration, oxidation resistance, swell ratio, hip simulator wear (normal and abrasive conditions), wear particle characterization, rim impingement, liner push-out, torque-out resistance, GCMS analysis of hexane and IPA extracts, consolidation assessment, fatigue crack propagation, trans-vinylene index, cyclic loading with accelerated ageing, and biocompatibility (genotoxicity, acute systemic toxicity, irritation, sensitization, cytotoxicity, implantation). The document states: "The additional components of the Trinity Acetabular System are similar to the predicate devices in terms of intended use and indications, materials, sizes, designs and performance. Based on these similarities, the additional components of the Trinity Acetabular System are believed to be substantially equivalent to the predicate devices." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable. No clinical test set. The non-clinical tests would have their own sample sizes but these are not disclosed in the summary.
- Data Provenance: Not applicable. No clinical data is presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. No clinical test set or ground truth established by experts.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. No clinical study, and no human-in-the-loop AI component discussed.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This device is a physical medical implant, not an algorithm or AI system.
7. Type of Ground Truth Used
- For the non-clinical tests, the ground truth would be the objectively measured values of the material and mechanical properties. For the purpose of the 510(k), the "ground truth" for substantial equivalence is the predicate device's characteristics and performance, against which the new device's non-clinical test results are compared.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical implant, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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Image /page/0/Picture/0 description: The image shows a handwritten number, "K111481". The number is written in black ink on a white background. The number is slightly slanted to the right. The number is easy to read.
FEB - 6 2012
3. 510(K) SUMMARY
- Corin USA 1. Applicant/Sponsor: 10500 University Center Drive Suite 190 Tampa, Florida 33612 Establishment Registration No .:
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- Contact Person: Lucinda Gerber Regulatory Affairs Associate Corin USA 813-977-4469 lucinda.gerber@coringroup.com
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- Date: 24 January, 2012
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- Proprietary Name: Corin Trinity Acetabular System ECIMA Liners
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- Common Name: Hip Prosthesis
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- Product Codes: OQI, LZO, MEH
7. Classification Name:
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21CFR 888.3353)
8. Legally Marketed Devices to which Substantial Equivalence is claimed:
- Corin Trinity Acetabular System with HXLPE Acetabular Liners (K110087)
9. Device Description:
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, ceramic and Co-Cr modular heads and titanium femoral stems.
The purpose of this submission is to add ECIMA acetabular liners to the Trinity Acetabular System. Corin's ECIMA is a cold irradiated, mechanically annealed, vitamin E blended ultra high molecular weight polyethylene.
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.
Page 1 of 2
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KIII481
10. Intended Use / Indications:
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 use only.
11. Summary of Technologies/Substantial Equivalence:
The additional components of the Trinity Acetabular System are similar to the predicate devices in terms of intended use and indications, materials, sizes, designs and performance. Based on these similarities, the additional components of the Trinity Acetabular System are believed to be substantially equivalent to the predicate devices.
12. Non-Clinical Testing:
Non-clinical testing was performed on ECiMa acetabular liners to determine tensile strength, impact strength, compressive strength, small punch strength, thermal properties, free radical concentration, oxidation resistance, swell ratio, hip simulator wear under normal and abrasive conditions, wear particle characterization, rim impingement, liner push-out, and torque-out resistance, GCMS analysis of hexane and IPA extracts, consolidation assessment, fatigue crack propagation, trans-vinylene index, cyclic loading with accelerated ageing and biocompatibility (i.e., genotoxicity, acute systemic toxicity, irritation, sensitization, cytotoxicity and implantation).
13. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the ECIMA liners of the Trinity Acetabular System and the predicate devices.
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract image of an eagle or bird-like figure, with three curved lines representing the wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Corin USA % Ms. Lucinda Gerber Regulatory Affairs Associate 10500 University Center Drive, Suite 190 Tampa, Florida 33612
FEB - 6 2012
Re: K111481
Trade/Device Name: Trinity Acetabular 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: OQI, LZO, MEH Dated: January 25, 2012 Received: January 26, 2012
Dear Ms. Gerber:
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 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.
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Page 2 - Ms. Lucinda Gerber
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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE 2.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Trinity Acetabular System
Indications for Use:
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular O necrosis
- Rheumatoid arthritis 0
- Correction of functional deformity 0
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) o
The Trinity Acetabular System is intended 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)
i"
(Diy sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1_of 1
510(k) Number K114581
§ 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.