(112 days)
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing related to AI/ML.
Yes.
This device is a total hip arthroplasty system, which is used to replace a damaged hip joint and restore its function, thus treating conditions like osteoarthritis and avascular necrosis.
No
The device description clearly states it is a "modular acetabular cup system" used in total hip arthroplasty, indicating it is an implant for treatment, not for diagnosis.
No
The device description clearly outlines a physical, modular acetabular cup system made of titanium alloy, polyethylene, ceramic, and CoCr materials, intended for surgical implantation. It is a hardware device.
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 total hip arthroplasty to treat various conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a hip replacement system (shells, liners, heads, stems). These are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, tissue, etc.) or providing information for diagnosis. The device is designed to replace a damaged joint.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
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 (comma separated list FDA assigned to the subject device)
LZO, MEH
Device Description
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell, ultra-high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (HXLPE), vitamin E highly cross-linked polyethylene (ECiMa) acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW, BIOLOX delta ceramic and CoCr modular heads and titanium femoral stems. The acetabular shells are coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
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:
Non-clinical testing conducted to demonstrate substantial equivalence includes: determination of shell suffness, effect of the coating process on shell taper form, and the effect of shell deformation on HXLPE and ECiMa liners. Bench testing of the Trinity titanium shells and characterization and testing for the coating was included in previous submissions for the Corin Trinity Acetabular System (K093472 and K110087).
Clinical Testing:
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): 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
K122305 (pg 1/2)
| 3. 510(K) SUMMARY | ||
|---|---|---|
| 1. Applicant/Sponsor: | Corin USA | |
| 10500 University Center Drive | ||
| Suite 190 | ||
| Tampa, Florida 33612 | ||
| Establishment Registration No.: 1056629 | ||
| 2. Contact Person: | Diana L. Martone | |
| Regulatory Affairs Associate | ||
| Corin USA | ||
| 813-977-4469 | ||
| diana.martone@coringroup.com | ||
| 3. Proprietary Name: | Corin Trinity Acetabular System with Trinity-i Acetabular Shells | |
| 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) | |
| 7. Device Description: | The Trinity Acetabular System is a modular acetabular cup system consisting of a | |
| press fit, titanium alloy shell, ultra-high molecular weight polyethylene (UHMWPE), highly | ||
| cross-linked polyethylene (HXLPE), vitamin E highly cross-linked polyethylene (ECiMa) | ||
| acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW, | ||
| BIOLOX deltaTM ceramic and CoCr modular heads and titanium femoral stems. The | ||
| acetabular shells are coated with a rough titanium plasma spray with an additional top layer | ||
| of electrochemically deposited calcium phosphate (BonitTM). |
ರ್ವ inner diameter, but with the samc outer diameter, to accommodate a larger liner and corresponding head size 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
1
K122305 (pg 2/2)
joint articulation where there is evidence of sufficient sound bone to seat and support the components.
8. 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 o
- Rheumatoid arthritis 0
- o Correction of functional deformity
- O Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Trinity Acetabular System is intended for cementless, single use only.
-
- Summary of Technologies/Substantial Equivalence:
The additional components of the Trinity Acetabular System are exactly the same as the predicate devices in terms of intended use, indications for use, and materials; and are similar in sizes, design and performance. Based on these similarities, 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 substantial equivalence includes: determination of shell suffness, effect of the coating process on shell taper form, and the effect of shell deformation on HXLPE and ECiMa liners. Bench testing of the Trinity titanium shells and characterization and testing for the coating was included in previous submissions for the Corin Trinity Acetabular System (K093472 and K110087).
- 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
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 symbol resembling a human figure embracing a sphere or globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 21, 2012
Corin USA % Ms. Diana L. Martone Regulatory Affairs Associate 10500 University Center Drive Tampa, Florida 33612
Re: K122305
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: II Product Code: LZO, MEH Dated: November 9, 2012
Received: November 13, 2012
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 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
3
Page 2 - Ms. Diana L. Martone
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE 2.
510(k) Number (if known): K122305
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
- Correction of functional deformity O
- 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)
Krishna Asundi (Division Sign-Off) Division of Orthopedic Devices 2012.11.20 08:12:26 -05'00'
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