(267 days)
Not Found
No.
The document describes a medical implant (acetabular shell) and its mechanical properties and indications for use, with no mention of AI models for its function or development.
Yes
The device, an acetabular shell used in total hip arthroplasty, is designed to replace a damaged hip joint articulation to increase mobility and reduce pain, which are therapeutic outcomes.
No
The device is an acetabular shell used in total hip arthroplasty, which is a treatment for various hip conditions, not a tool for diagnosing them.
No
The device description clearly indicates that the Trinity™ EVO Acetabular Shell is a physical hip implant component made of titanium alloy, designed for total hip arthroplasty procedures. It undergoes extensive mechanical and material testing, confirming it as a hardware device, not software.
No.
The device is an implantable prosthetic device for total hip arthroplasty, not a diagnostic tool that examines specimens from the human body.
N/A
Intended Use / Indications for Use
The indications for the Trinity™ EVO Acetabular Shell 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)/Congenital dislocation of the hip (CDH)
The Trinity™ EVO acetabular shell is also indicated for use in revisions of a previously failed total hip arthroplasty.
The Trinity™ EVO Acetabular Shell is indicated for cementless use only.
Product codes
LPH, LZO, OQG, OQI, MBL
Device Description
The Trinity™ EVO acetabular shell forms part of a modular acetabular system. The Trinity™ EVO acetabular shell is a hemispherical press fit titanium alloy shell for use with cobalt chrome alloy (Trinity™ Dual Mobility only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip arthroplasty (THA) procedures using Corin metal stems with a 12/14 taper connection. The Trinity™ EVO acetabular shell has a porous structure manufactured from titanium alloy powder, produced via additive manufacturing using Laser Powder Bed Fusion (LPBF), and is available with or without an additional layer of electrochemically deposited calcium phosphate. The Trinity™ EVO acetabular shell is provided in sizes permitting the use of titanium bone screws to provide additional fixation, if required. The Trinity™ EVO acetabular shell is also available without screw holes. A titanium occluder is provided to occlude the apical introducer hole.
The Trinity™ EVO acetabular shell is intended for use in primary and revision THA in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation when there is evidence of sufficient sound bone to seat and support the components.
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:
Static Tests
- Static Shear as per ASTM F1044-05(2017)
- Compression as per ISO 13314:2011
- Deformation testing as per ISO 7206-12:2016
- Deformation testing with bone foam as per internal protocol
- Liner Disassembly as per ASTM F1820-22
- Roughness testing as per DIN EN ISO 4287:1998+A1:2009
Dynamic Tests
- Taber Abrasion as per ASTM F1978-22
- Shell Fatigue per ASTM F3090-20
Additional Testing
- Cadaveric Testing as per internal protocol
- Porous Structure Characterization as per ASTM F1854-15
- Residual Powder Gravimetric Testing as per ASTM F2459-18
- MicroCT Porous Structure Characterization as per internal protocol
- Screw Pull Through Testing as per internal protocols
- Bacterial Endotoxin Testing (BET) conducted on finished, sterilized product, using Limulus Amoebocyte Lysate (LAL) kinetic chromogenic methodology
Specific mechanical and characterization testing was performed by Corin on the Trinity™ EVO Acetabular Shell. The results of this testing show that the Trinity™ EVO Acetabular Shell is substantially equivalent to the predicate devices. A comparison of indications for use and contraindications also demonstrated substantial equivalence.
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
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
FDA 510(k) Clearance Letter - Trinity EVO Acetabular Shell
Page 1
June 5, 2025
Corin USA Limited
Aaron Brunt
Regulatory Affairs Manager
12750 Citrus Park Lane
Tampa, Florida 33625
Re: K242744
Trade/Device Name: Trinity EVO Acetabular Shell
Regulation Number: 21 CFR 888.3358
Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis
Regulatory Class: Class II
Product Code: LPH, LZO, OQG, OQI, MBL
Dated: September 11, 2024
Received: May 1, 2025
Dear Aaron Brunt:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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K242744 - Aaron Brunt Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K242744 - Aaron Brunt Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
RYAN TROMBETTA -S
For: Limin Sun, Ph.D.
Assistant Director
DHT6A: Division of Joint
Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K242744
Device Name
Trinity EVO Acetabular Shell
Indications for Use (Describe)
The indications for the Trinity™ EVO Acetabular Shell 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)/Congenital dislocation of the hip (CDH)
The Trinity™ EVO acetabular shell is also indicated for use in revisions of a previously failed total hip arthroplasty.
The Trinity™ EVO Acetabular Shell is indicated for cementless use only.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 1 of 1
Page 5
510(k) Summary
510(k) #: K242744
Prepared on: 2025-05-01
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| Applicant Name | Corin USA Limited |
| Applicant Address | 12750 Citrus Park Lane Tampa FL 33625 United States |
| Applicant Contact Telephone | +4407970237346 |
| Applicant Contact | Mr. Aaron Brunt |
| Applicant Contact Email | aaron.brunt@coringroup.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Value |
|---|---|
| Device Trade Name | Trinity EVO Acetabular Shell |
| Common Name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Classification Name | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis |
| Regulation Number | 888.3358 |
| Product Code(s) | LPH, LZO, OQG, OQI, MBL |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate# | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K172551 | Trinity PLUS Acetabular Shell | LPH |
| K181366 | REDAPT Porous Acetabular Shell | LPH |
Device Description Summary
21 CFR 807.92(a)(4)
The Trinity™ EVO acetabular shell forms part of a modular acetabular system. The Trinity™ EVO acetabular shell is a hemispherical press fit titanium alloy shell for use with cobalt chrome alloy (Trinity™ Dual Mobility only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip arthroplasty (THA) procedures using Corin metal stems with a 12/14 taper connection. The Trinity™ EVO acetabular shell has a porous structure manufactured from titanium alloy powder, produced via additive manufacturing using Laser Powder Bed Fusion (LPBF), and is available with or without an additional layer of electrochemically deposited calcium phosphate. The Trinity™ EVO acetabular shell is provided in sizes permitting the use of titanium bone screws to provide additional fixation, if required. The Trinity™ EVO acetabular shell is also available without screw holes. A titanium occluder is provided to occlude the apical introducer hole.
The Trinity™ EVO acetabular shell is intended for use in primary and revision THA in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation when there is evidence of sufficient sound bone to seat and support the components.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
K242744
Page 1 of 3
Page 6
The indications for the Trinity™ EVO Acetabular Shell 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)/Congenital dislocation of the hip (CDH)
The Trinity™ EVO acetabular shell is also indicated for use in revisions of a previously failed total hip arthroplasty.
The Trinity™ EVO Acetabular Shell is indicated for cementless use only.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The Trinity™ EVO Acetabular Shell, subject of this submission, has the same indications for use as those used in the primary predicate device (K172551). Trinity™ EVO Acetabular Shell also has similar indications for use as those referenced in REDAPT Porous Acetabular Shell (K181366).
Technological Comparison
21 CFR 807.92(a)(6)
The Trinity™ EVO Acetabular Shell uses similar materials to the predicate Trinity™ PLUS Acetabular Shell (K172551). The range of sizes available for the Trinity™ EVO Acetabular Shell is identical to the range cleared for the predicate device.
The outer porous structure, produced by an additive manufacture technique, of the Trinity™ EVO Acetabular Shell is similar to the predicate.
The inner shell incorporates the Corin Trinity™ Acetabular Shell design, dimensions, and locking mechanisms. The electrochemically deposited calcium phosphate coating on the Corin Trinity™ EVO Acetabular Shell is similar to that on the predicate.
The Trinity™ EVO Acetabular Shell also has similar sizes and dimensions, and is manufactured from similar material (Ti6Al4V) to those used in the secondary predicate, REDAPT Porous Acetabular Shell (K181366). The REDAPT Porous Acetabular Shell predicate is primarily for residual powder comparison.
Based on these similarities, Corin believes that the Trinity™ PLUS Acetabular Shell is substantially equivalent to the predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
K242744
Page 2 of 3
Page 7
Previous testing was completed on the Trinity™ PLUS Acetabular Shell (K172551) to support substantial equivalence. This testing is applicable to the Trinity™ EVO Acetabular Shells as the sizing and the liner mating features are identical.
Non-clinical testing conducted to demonstrate substantial equivalence includes:
Static Tests
- Static Shear as per ASTM F1044-05(2017)
- Compression as per ISO 13314:2011
- Deformation testing as per ISO 7206-12:2016
- Deformation testing with bone foam as per internal protocol
- Liner Disassembly as per ASTM F1820-22
- Roughness testing as per DIN EN ISO 4287:1998+A1:2009
Dynamic Tests
- Taber Abrasion as per ASTM F1978-22
- Shell Fatigue per ASTM F3090-20
Additional Testing
- Cadaveric Testing as per internal protocol
- Porous Structure Characterization as per ASTM F1854-15
- Residual Powder Gravimetric Testing as per ASTM F2459-18
- MicroCT Porous Structure Characterization as per internal protocol
- Screw Pull Through Testing as per internal protocols
- Bacterial Endotoxin Testing (BET) conducted on finished, sterilized product, using Limulus Amoebocyte Lysate (LAL) kinetic chromogenic methodology
Not applicable
Specific mechanical and characterization testing was performed by Corin on the Trinity™ EVO Acetabular Shell. The results of this testing show that the Trinity™ EVO Acetabular Shell is substantially equivalent to the predicate devices. A comparison of indications for use and contraindications also demonstrated substantial equivalence.
K242744
Page 3 of 3