(71 days)
No
The document describes a mechanical implant (acetabular cup system) and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies are based on non-clinical bench testing.
Yes
The device is intended to reduce pain and increase mobility by replacing a damaged hip joint, which aligns with the definition of a therapeutic effect.
No
The device is a modular acetabular cup system used in total hip arthroplasty to replace a damaged hip joint, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components made of titanium alloy, UHMWPE, HXLPE, vitamin E highly crosslinked polyethylene, ceramic, and CoCr, which are implanted in the body. This is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Trinity Acetabular System is a physical implant designed to replace a damaged hip joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to provide increased mobility and reduce pain by replacing the damaged hip joint articulation. This is a surgical intervention, not a diagnostic test performed on a specimen.
The provided information clearly describes a surgical implant, not a device used for testing biological samples.
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 indicated 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 with ultra high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (HXLPE) and vitamin E highly crosslinked polyethylene (ECiMa) acetabular liners in neutral offset, +4mm offset, +4mm oblique and neutral 4mm EPW. The Trinity system also includes BIOLOX delta™ ceramic and CoCr modular heads which are intended for use with Corin titanium femoral stems. The acetabular shell comes in two variants, a standard Trinity (K093472 and K110087) and a Trinity-i (K122305) shell, both coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The Trinity and Trinity-i acetabular shells are provided with screw holes and come assembled with ttanium occluders in place. Dedicated titanium screws are also provided for additional fixation if required.
The purpose of this submission is to add two more acetabular shell variants to the Trinity Acetabular System, the standard Trinity Non-occluded Titanium Plasma Sprayed (TPS) acetabular shell and the Trinity-i Non-occluded Titanium Plasma Sprayed (TPS) acetabular shell. Both of these variants, subject of this submission, are coated with a rough titanium plasma spray, contain non-threaded holes for the use of titanium screw fixation and do not come pre-assembled with the hole occluders in place.
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: screw range of motion and bench testing of the Trinity titanium shells and characterization and testing for the coating which were included in previous submissions for the Corin standard Trinity Acetabular Shells (K093472 and K110087) and the Trinity-i Acetabular Shells (K122305).
The results of this testing show that the Trinity and Trinity-i non-occluded TPS variants are expected to be safe and effective for the proposed indications and are substantially equivalent to 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.
K093472, K110087, K122305, K050262
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.
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FEB 1 2 2013
Page 1 of 1
| 3. | 510(K) SUMMARY | |
|---|---|---|
| 1. Applicant/Sponsor: | Corin USA | |
| 5670 W. Cypress St. | ||
| Suite C | ||
| Tampa, Florida 33607 | ||
| Establishment Registration No.: 1056629 | ||
| 2. Contact Person: | Diana L. Martone, MS | |
| Regulatory Affairs Associate | ||
| Corin USA | ||
| 813-977-4469 | ||
| diana.martone@coringroup.com | ||
| 3. Proprietary Name: | Trinity Non-occluded Titanium Plasma Sprayed (TPS) 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 |
- Legally Marketed Devices to which Substantial Equivalence is claimed:
a. Corin Trinity Acetabular System (K093472)
b. Corin Trinity Acetabular System with HXLPE (K110087)
c. Corin Trinity Acetabular System with Trinity-i Acetabular Shells (K122305)
d. United U2 Acetabular Component (K050262)
7. Device Description:
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell with ultra .high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (HXLPE) and vitamin E highly crosslinked polyethylene (ECiMa) acetabular liners in neutral offset, +4mm offset, +4mm oblique and neutral 4mm EPW. The Trinity system also includes BIOLOX delta™ ceramic and CoCr modular heads which are intended for use with Corin titanium femoral stems. The acetabular shell comes in two variants, a standard Trinity (K093472 and K110087) and a Trinity-i (K122305) shell, both coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited
1
calcium phosphate (Bonit™). The Trinity and Trinity-i acetabular shells are provided with screw holes and come assembled with ttanium occluders in place. Dedicated titanium screws are also provided for additional fixation if required.
The purpose of this submission is to add two more acetabular shell variants to the Trinity Acetabular System, the standard Trinity Non-occluded Titanium Plasma Sprayed (TPS) acetabular shell and the Trinity-i Non-occluded Titanium Plasma Sprayed (TPS) acetabular shell. Both of these variants, subject of this submission, are coated with a rough titanium plasma spray, contain non-threaded holes for the use of titanium screw fixation and do not come pre-assembled with the hole occluders in place.
8. Intended Use / Indications:
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 O
- Correction of functional deformity o
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip 0 (CDH)
The Trinity Acetabular System is indicated for cementless, single use only.
-
- Summary of Technologies/Substantial Equivalence:
The standard Trinity Non-occluded TPS shell is identical to the standard Trinity Acetabular Shell cleared in K093472 and K110087 in terms of intended use, indications for use, substrate materials, and size range. Likewise, the Trinity-i Nonoccluded TPS shell is identical to the Trinity-i Acctabular Shell cleared in K122305 in terms of intended use, indications for use, substrate materials, and size range. The standard Trinity Non-occluded TPS and the Trinity-i Non-occluded TPS shells are similar in design to the Corin predicates with non-threaded holes for the use of titanium screw fixation and a rough titanium plasma spray coating only. The titanium plasma spray coating of the non-occluded TPS variants, subject of this submission, is similar to the titanium plasma spray coating of the United U2
- Summary of Technologies/Substantial Equivalence:
2
Acetabular Component (K050262) and identical to the titanium plasma spray coating applied to predicates K093472, K110087, and K122305. Based on these similarities, the additional variants subject of this submission, are determined to be substantially equivalent to the predicate devices.
10. Non-Clinical Testing:
Non-clinical testing conducted to demonstrate substantial equivalence includes: screw range of motion and bench testing of the Trinity titanium shells and characterization and testing for the coating which were included in previous submissions for the Corin standard Trinity Acetabular Shells (K093472 and K110087) and the Trinity-i Acetabular Shells (K122305).
The results of this testing show that the Trinity and Trinity-i non-occluded TPS variants are expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices.
11. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence with the predicate devices.
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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal 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 20993-002
Letter dated: February 12, 2013
Corin USA % Ms. Diana L. Martone Regulatory Affairs Associate 5670 W. Cypress Street, Suite C Tampa, Florida 33607
Re: K123705
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: November 30, 2012 Received: December 3. 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. Iisting 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
4
Page 2 - Ms. Diana L. Martone
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark Navlélkerson
Mark N. Melkerson Director . Division of Orthopedic Devices Office of Device Evaluation Center for Devices and . Radiological Health
Enclosure
5
INDICATIONS FOR USE 2.
510(k) Number (if known): K123705
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) 0
The Trinity Acetabular System is indicated 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)
Michael C. Owens
Division of Orthopedic Devices