(106 days)
No
The document describes a modular acetabular cup system and its components, focusing on materials and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a medical implant (total hip arthroplasty system) used to treat specific medical conditions, which inherently makes it a therapeutic device.
No
The device description clearly states "The Trinity Acetabular System is a modular acetabular cup system" used to address conditions like "degenerative joint disease" and "rheumatoid arthritis" through a "total hip arthroplasty." This indicates it is a therapeutic or reconstructive device, not one designed to diagnose a condition.
No
The device description clearly outlines physical components made of titanium alloy, ceramic, and CoCrMo, which are hardware. The submission is for adding new physical components (femoral heads) to an existing hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty to treat various hip conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a hip replacement system (acetabular cup, liners, femoral heads). These are physical components implanted in the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, tissue, etc.) or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 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.
Product codes
LZO, MEH
Device Description
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium allov shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems.
The purpose of this submission is to add 32mm (+7mm offset), 36mm (+8mm offset), and 40mm (+8mm offset) CoCrMo and BIOLOX delta™ ceramic extralong femoral heads to the Trinity Acetabular System.
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
skeletally mature patients
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: stem fatigue testing and neck fatigue testing with head offsets representing the worse-case scenario.
Clinical testing was not necessary to determine substantial equivalence between the additional components of the Trinity Acetabular System and the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
510(K) SUMMARY 3.
| 1. Applicant/Sponsor: | Corin USA
5670 West Cypress Street
Suite C
Tampa, Florida 33607
Establishment Registration No.: 1056629 |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Persons: | Diana L. Martone
Regulatory Affairs Associate
Corin USA
813-977-4469
diana.martone@coringroup.com
Kathy Trier
Vice President of Clinical and Regulatory
Corin USA
813-977-4469
kathy.trier@coringroup.com |
| 3. Proprietary Name: | Corin Trinity Acetabular System with Extra Long Heads |
| 4. Common Name: | Hip Prosthesis |
| 5. Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (21CFR 888.3353)
Product Codes: LZO, MEH |
| 6. Legally Marketed Devices to which Substantial Equivalence is claimed: | • Corin Trinity Acetabular System (K093472) |
- · Corin Trinity Acetabular System with HXLPE Liners (K110087)
- Trinity Biolox delta Modular Heads (K103120)
7. Device Description:
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium allov shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems.
The purpose of this submission is to add 32mm (+7mm offset), 36mm (+8mm offset), and 40mm (+8mm offset) CoCrMo and BIOLOX delta™ ceramic extralong femoral heads to the Trinity Acetabular System.
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 articulational there is evidence of sufficient sound bone
1
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:
-
0 Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
Rheumatoid arthritis o
-
Correction of functional deformity 0
-
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.
-
Summary of Technologies/Substantial Equivalence: 9.
The additional components of the Trinity Acetabular System are identical to the predicate devices in terms of intended use and indications, and materials, and similar in sizes, designs and performance. Based on these characteristics, the additional components of the Trinity Acetabular System are believed to be substantially equivalent to the predicate devices. -
- Non-Clinical Testing:
Non-clinical testing conducted to demonstrate substantial equivalence includes: stem fatigue testing and neck fatigue testing with head offsets representing the worse-case scenario.
- Non-Clinical Testing:
11. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the additional components of the Trinity Acetabular System and the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling waves or flowing lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2013
Corin USA % Ms. Diana Martone Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607
Re: K130343
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: LZO, MEH Dated: February 7, 2013 Received: February 27, 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 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
3
Page 2 - Ms. Diana 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/ReportalProblem/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.
Image /page/3/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The letters "Erin" are in a bold, sans-serif font, while the "D" is a more intricate, almost circuit-like design. The name "Keith" is in a similar style to "Erin", but with a slightly more decorative touch.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
· 2. INDICATIONS FOR USE
510(k) Number (if known): _K130343 (pg 1/1)
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 O
- 0 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.
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)
Elizabeth L. Frank -S
Page 1 of 1
Division of Orthopedic Devices