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.

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.

AI/ML Overview

This document describes a 510(k) submission for the Corin Trinity Acetabular System with Extra Long Heads. It is a modification to an existing hip prosthesis system. The key takeaway is that no clinical studies were conducted to demonstrate the device meets acceptance criteria. Instead, it relies on non-clinical testing and substantial equivalence to predicate devices. Therefore, many of the requested fields regarding clinical study details cannot be populated.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Non-clinical Testing:	Non-clinical Testing:
Stem fatigue testing	Performed (results not detailed, but considered sufficient to demonstrate substantial equivalence)
Neck fatigue testing with worse-case head offsets	Performed (results not detailed, but considered sufficient to demonstrate substantial equivalence)
Clinical Testing:	Clinical Testing:
Not applicable (no clinical testing performed)	Not applicable

2. Sample size used for the test set and the data provenance

Not Applicable: No clinical test set was used. Non-clinical testing (fatigue testing) typically involves a small number of samples (e.g., 6-12 samples per condition) tested under specified load conditions, but the exact sample sizes are not provided in this summary. The data provenance would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: Given that no clinical studies were performed and the device relies on non-clinical testing and substantial equivalence, there was no "ground truth" established by experts in the context of a clinical test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable: No clinical test set and thus no adjudication method for ground truth determination.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This device is a hip implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable: This is a physical medical device (hip prosthesis), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable: For the non-clinical testing, the "ground truth" would be the engineering specifications and performance standards for fatigue resistance. For the regulatory submission, the "ground truth" is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not Applicable: No training set was used as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not Applicable: No training set was used.

Summary

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510(K) SUMMARY 3.

1. Applicant/Sponsor:	Corin USA5670 West Cypress StreetSuite CTampa, Florida 33607Establishment Registration No.: 1056629
2. Contact Persons:	Diana L. MartoneRegulatory Affairs AssociateCorin USA813-977-4469diana.martone@coringroup.comKathy TrierVice President of Clinical and RegulatoryCorin USA813-977-4469kathy.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 ornonporous 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 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

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to seat and support the components.

1. Intended Use / Indications:
  The indications for the Trinity Acetabular System as a total hip arthroplasty include:
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.
1. 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.

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.

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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

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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

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· 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

Regulation Number and Section

§ 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.