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.

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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Corin Trinity Non-occluded Titanium Plasma Sprayed (TPS) Acetabular Shells. It clarifies that no clinical testing was deemed necessary to demonstrate substantial equivalence, and therefore, the concept of "acceptance criteria" as applied to device performance in a clinical study isn't directly applicable for this submission.

Instead, the submission relies on non-clinical testing to show that the new variants are substantially equivalent to previously cleared predicate devices. Substantial equivalence for this medical device (hip prosthesis components) is established by demonstrating that the new devices have the same intended use, indications for use, substrate materials, and similar design and coating characteristics as the predicate devices, and that non-clinical testing supports their safety and effectiveness.

Here's an analysis based on the provided document, addressing the specific points where information is available or noting its absence:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission for substantial equivalence based on non-clinical testing, explicit "acceptance criteria" and "device performance" in terms of clinical outcomes are not defined in the provided text. The "performance" is demonstrated through substantial equivalence to predicate devices and non-clinical bench testing.

Acceptance Criterion (Implicit)	Reported "Device Performance"
Intended Use: (Same as predicate devices)	The standard Trinity Non-occluded TPS shell is identical to the standard Trinity Acetabular Shell (K093472 and K110087) in terms of intended use. The Trinity-i Non-occluded TPS shell is identical to the Trinity-i Acetabular Shell (K122305) in terms of intended use.
Indications for Use: (Same as predicate devices)	The standard Trinity Non-occluded TPS shell is identical to the standard Trinity Acetabular Shell (K093472 and K110087) in terms of indications for use. The Trinity-i Non-occluded TPS shell is identical to the Trinity-i Acetabular Shell (K122305) in terms of indications for use.
Substrate Materials: (Same as predicate devices)	The standard Trinity Non-occluded TPS shell is identical to the standard Trinity Acetabular Shell (K093472 and K110087) in terms of substrate materials. The Trinity-i Non-occluded TPS shell is identical to the Trinity-i Acetabular Shell (K122305) in terms of substrate materials.
Size Range: (Same as predicate devices)	The standard Trinity Non-occluded TPS shell is identical to the standard Trinity Acetabular Shell (K093472 and K110087) in terms of size range. The Trinity-i Non-occluded TPS shell is identical to the Trinity-i Acetabular Shell (K122305) in terms of size range.
Design Similarity: (Similar to predicate devices, specifically regarding non-threaded holes for screw fixation and rough TPS coating)	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.
Coating Characteristics: (Similar/identical to predicate devices)	The titanium plasma spray coating of the non-occluded TPS variants is similar to the titanium plasma spray coating of the United U2 Acetabular Component (K050262) and identical to the titanium plasma spray coating applied to predicates K093472, K110087, and K122305.
Non-Clinical Test Results: (Demonstrate safety and effectiveness, supporting substantial equivalence)	"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... 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." (Specific numeric acceptance criteria for these tests are not provided in this summary.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for specific non-clinical tests in this 510(k) summary. These would typically be detailed in the full non-clinical test reports submitted to the FDA, but not in the summary.
Data Provenance: Not applicable in the context of an AI device's test set for a clinical study, as this submission is for a medical implant and relies on non-clinical (bench) testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No clinical test set or human expert review for establishing ground truth was used for this submission. The "ground truth" for substantial equivalence is derived from the characteristics of the predicate devices and the results of non-clinical engineering and material tests.

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

Not applicable. No clinical test set requiring adjudication was used.

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 is not an AI device or a diagnostic imaging device requiring human reader assessment. It is a hip prosthesis component.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" in this context is the established safety and effectiveness of the predicate devices, as demonstrated through their own prior clearances (K093472, K110087, K122305, K050262) and the engineering and material science principles applied in the non-clinical testing. It's essentially equivalence to known performance of existing devices.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device.

Summary

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K123705.

FEB 1 2 2013

Page 1 of 1

	3.	510(K) SUMMARY
1. Applicant/Sponsor:	Corin USA5670 W. Cypress St.Suite CTampa, Florida 33607Establishment Registration No.: 1056629
2. Contact Person:	Diana L. Martone, MSRegulatory Affairs AssociateCorin USA813-977-4469diana.martone@coringroup.com
3. Proprietary Name:	Trinity Non-occluded Titanium Plasma Sprayed (TPS) AcetabularShells
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

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:

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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.

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
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.

1. 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

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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

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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

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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

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.