(267 days)
No
The description focuses on the mechanical components and materials of a hip implant system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total hip arthroplasty system, which is used to replace the hip joint articulation to reduce pain and increase stability, thereby treating various degenerative joint diseases and correcting functional deformities.
No
This device is a surgical implant designed to replace a hip joint. Its intended use is therapeutic (treating conditions like osteoarthritis and rheumatoid arthritis), not diagnostic (identifying or characterizing disease).
No
The device description clearly outlines physical components made of Cobalt Chromium Alloy and polyethylene, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing the hip joint articulation. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a hip implant system (liners, inserts, femoral heads, shells). This is consistent with a medical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue) or providing information about a patient's health status based on such analysis. IVDs are designed for these purposes.
The device is a medical device used for surgical intervention in the hip joint.
N/A
Intended Use / Indications for Use
The Trinity™ Dual Mobility System is intended for use in the following indications:
-
- Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis
-
- Rheumatoid Arthritis
-
- Correction of functional deformity
-
- Revision of previously failed total hip arthroplasty,
-
- Patients at increased risk of dislocation
-
- Developmental dysplasia of the hip (DDH)
The TrinityTM Dual Mobility System is indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH
Device Description
The Trinity™ Dual Mobility System is a modular system consisting of two articulating surfaces in the same joint space. The system includes a highly polished Cobalt Chromium Alloy (CoCr) liner that articulates with an ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) mobile insert. A Trinity™ femoral head, 22mm or 28mm CoCr or 28mm BIOLOX® delta heads, articulates within the ECiMa™ mobile insert to allow for a second articulation. The Trinity™ Dual Mobility System is intended to be used only with compatible Trinity™ acetabular Shells. The Trinity™ Dual Mobility System is designed for use with any Corin femoral stem with a 12/14 taper connection. The Trinity™ Dual Mobility System is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The Trinity™ Dual Mobility System is intended to be used with the following approved devices:
- Trinity™ Acetabular Shells (Sizes 2- 5) (K093472, K123705, K122305, K130128) .
- 28mm CoCr heads (K110087, K131647) .
- . 28mm BIOLOX® delta Ceramic Heads (K103120)
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 conducted to demonstrate substantial equivalence includes static tests (Push-out, lever-out, torque-off) and Dynamic Tests (Impingement, corrosion, range of motion, and wear). The results of this testing show that the Trinity™ Dual Mobility System 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.
K103233, K150522, K110087, K111481, K131647
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.
K093472, K123705, K122305, K130128, K110087, K131647, K103120
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/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.
October 31, 2017
Corin USA Limited Lucinda Gerber Global Regulatory Affairs Manager 5670 W Cypress Street, Suite C Tampa, Florida 33607
Re: K170359
Trade/Device Name: Trinity Dual Mobility 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: September 28, 2017 Received: September 29, 2017
Dear Lucinda 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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 (DICE) 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 (DICE) 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,
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) K170359
Device Name Trinity™ Dual Mobility System
Indications for Use (Describe) The Trinity™ Dual Mobility System is intended for use in the following indications:
-
- Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis
-
- Rheumatoid Arthritis
-
- Correction of functional deformity
-
- Revision of previously failed total hip arthroplasty,
-
- Patients at increased risk of dislocation
-
- Developmental dysplasia of the hip (DDH)
The TrinityTM Dual Mobility System is indicated for cementless use only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
3. 510(k) SUMMARY
| 1. Applicant/Sponsor: | Corin USA
12750 Citrus Park Lane
Suite 120
Tampa, Florida 33625
Establishment Registration No.: 1056629 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Lucinda Gerber, BA (Hons)
Global Regulatory Affairs Manager
Corin Ltd / Corin USA
1 (772) 321-2478
lucinda.gerber@coringroup.com |
| 3. Date: | February 2, 2017 |
| 4. Proprietary Name: | Trinity™ Dual Mobility System |
| 5. Common Name: | Hip Prosthesis |
| 6. Product Code(s): | LZO, MEH |
| 7. Classification Name: | 888.3353 - Hip joint metal/ceramic/ polymer semi-constrained cemented or
Nonporous uncemented prosthesis |
8. Legally Marketed Devices to which Substantial Equivalence is claimed:
- Stryker MDM™ (K103233) .
- Zimmer Biomet G7 Dual Mobility System (K150522) ●
- Corin Trinity Acetabular System (K110087, K111481, K131647) .
9. Device Description:
The Trinity™ Dual Mobility System is a modular system consisting of two articulating surfaces in the same joint space. The system includes a highly polished Cobalt Chromium Alloy (CoCr) liner that articulates with an ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) mobile insert. A Trinity™ femoral head, 22mm or 28mm CoCr or 28mm BIOLOX® delta heads, articulates within the ECiMa™ mobile insert to allow for a second articulation. The Trinity™ Dual Mobility System is intended to be used only with compatible Trinity™ acetabular Shells. The Trinity™ Dual Mobility System is designed for use with any Corin femoral stem with a 12/14 taper connection. The Trinity™ Dual Mobility System is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The Trinity™ Dual Mobility System is intended to be used with the following approved devices:
- Trinity™ Acetabular Shells (Sizes 2- 5) (K093472, K123705, K122305, K130128) .
- 28mm CoCr heads (K110087, K131647) .
- . 28mm BIOLOX® delta Ceramic Heads (K103120)
4
10. Intended Use / Indications:
The Trinity™ Dual Mobility system is intended for use in the following indications:
-
- Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis,
- Rheumatoid Arthritis, 2.
-
- Correction of functional deformity,
-
- Revision of previously failed total hip arthroplasty,
- Patients at increased risk of dislocation, 5.
-
- Developmental dysplasia of the hip (DDH),
The TrinityTM Dual Mobility System is indicated for cementless use only.
11. Summary of Technologies/Substantial Equivalence:
The Trinity™ Dual Mobility System is similar to the predicate devices (K110087, K111481, K150522 and K103233) in terms of intended use and indications, materials, sizes, design and testing. Based on these similarities, the Trinity™ Dual Mobility System is believed to be substantially equivalent to the predicate devices.
12. Pyrogenicity Assessment:
Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits.
13. Non-Clinical Testing:
Non-clinical testing conducted to demonstrate substantial equivalence includes static tests (Push-out, lever-out, torque-off) and Dynamic Tests (Impingement, corrosion, range of motion, and wear). The results of this testing show that the Trinity™ Dual Mobility System is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
14. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Trinity™ Dual Mobility System and the predicate devices.