Trinity™ Dual Mobility System

K170359 · Corin U.S.A. Limited · LZO · Oct 31, 2017 · Orthopedic

Device Facts

• Record ID: K170359
• Device Name: Trinity™ Dual Mobility System
• Applicant: Corin U.S.A. Limited
• Product Code: LZO · Orthopedic
• Decision Date: Oct 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trinity™ Dual Mobility System is intended for use in the following indications: - 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis - 2. Rheumatoid Arthritis - 3. Correction of functional deformity - 4. Revision of previously failed total hip arthroplasty, - 5. Patients at increased risk of dislocation - 6. Developmental dysplasia of the hip (DDH) The TrinityTM Dual Mobility System is indicated for cementless use only.

Device Story

Modular hip prosthesis system; provides two articulating surfaces in single joint space to increase stability and reduce pain. Components: highly polished Cobalt Chromium (CoCr) liner; ECiMa (Vitamin E UHMWPE) mobile insert; femoral head (22mm/28mm CoCr or 28mm BIOLOX delta ceramic). Designed for use with compatible Trinity acetabular shells and Corin femoral stems with 12/14 taper connection. Used by orthopedic surgeons in clinical settings for primary or revision total hip arthroplasty. Replaces hip joint articulation in patients with sufficient bone stock. Benefits include improved joint stability and reduced dislocation risk.

Clinical Evidence

No clinical data. Substantial equivalence determined via non-clinical bench testing, including static tests (push-out, lever-out, torque-off) and dynamic tests (impingement, corrosion, range of motion, and wear). Bacterial endotoxin testing met limits.

Technological Characteristics

Modular hip prosthesis. Materials: Cobalt Chromium Alloy (CoCr) liner, ECiMa (Vitamin E UHMWPE) mobile insert, BIOLOX delta ceramic or CoCr femoral heads. Cementless fixation. 12/14 taper connection. Mechanical articulation principle. No software or electronic components.

Indications for Use

Indicated for patients requiring primary or revision total hip arthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, developmental dysplasia of the hip (DDH), or those at increased risk of dislocation. Indicated for cementless use only.

Regulatory Classification

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.

Predicate Devices

• Stryker MDM (K103233)
• Zimmer Biomet G7 Dual Mobility System (K150522)
• Corin Trinity Acetabular System (K110087)
• Corin Trinity Acetabular System (K111481)
• Corin Trinity Acetabular System (K131647)

Reference Devices

• Trinity Acetabular Shells (K093472)
• Trinity Acetabular Shells (K123705)
• Trinity Acetabular Shells (K122305)
• Trinity Acetabular Shells (K130128)
• 28mm CoCr heads (K110087)
• 28mm CoCr heads (K131647)
• 28mm BIOLOX delta Ceramic Heads (K103120)

Submission Summary (Full Text)

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October 31, 2017

Corin USA Limited Lucinda Gerber Global Regulatory Affairs Manager 5670 W Cypress Street, Suite C Tampa, Florida 33607

Re: K170359

Trade/Device Name: Trinity Dual Mobility 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: September 28, 2017 Received: September 29, 2017

Dear Lucinda Gerber:

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] 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" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

510(k) Number (if known) K170359

Device Name Trinity™ Dual Mobility System

Indications for Use (Describe) The Trinity™ Dual Mobility System is intended for use in the following indications:

- 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis
- 2. Rheumatoid Arthritis
- 3. Correction of functional deformity
- 4. Revision of previously failed total hip arthroplasty,
- 5. Patients at increased risk of dislocation
- 6. Developmental dysplasia of the hip (DDH)

The TrinityTM Dual Mobility System is indicated for cementless use only.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 3. 510(k) SUMMARY

| 1. Applicant/Sponsor: | Corin USA<br>12750 Citrus Park Lane<br>Suite 120<br>Tampa, Florida 33625<br>Establishment Registration No.: 1056629 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Lucinda Gerber, BA (Hons)<br>Global Regulatory Affairs Manager<br>Corin Ltd / Corin USA<br>1 [phone]<br>[e-mail] |
| 3. Date: | February 2, 2017 |
| 4. Proprietary Name: | Trinity™ Dual Mobility System |
| 5. Common Name: | Hip Prosthesis |
| 6. Product Code(s): | LZO, MEH |
| 7. Classification Name: | 888.3353 - Hip joint metal/ceramic/ polymer semi-constrained cemented or<br>Nonporous uncemented prosthesis |

## 8. Legally Marketed Devices to which Substantial Equivalence is claimed:

- Stryker MDM™ (K103233) .
- Zimmer Biomet G7 Dual Mobility System (K150522) ●
- Corin Trinity Acetabular System (K110087, K111481, K131647) .

## 9. Device Description:

The Trinity™ Dual Mobility System is a modular system consisting of two articulating surfaces in the same joint space. The system includes a highly polished Cobalt Chromium Alloy (CoCr) liner that articulates with an ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) mobile insert. A Trinity™ femoral head, 22mm or 28mm CoCr or 28mm BIOLOX® delta heads, articulates within the ECiMa™ mobile insert to allow for a second articulation. The Trinity™ Dual Mobility System is intended to be used only with compatible Trinity™ acetabular Shells. The Trinity™ Dual Mobility System is designed for use with any Corin femoral stem with a 12/14 taper connection. The Trinity™ Dual Mobility System is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Trinity™ Dual Mobility System is intended to be used with the following approved devices:

- Trinity™ Acetabular Shells (Sizes 2- 5) (K093472, K123705, K122305, K130128) .
- 28mm CoCr heads (K110087, K131647) .
- . 28mm BIOLOX® delta Ceramic Heads (K103120)

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#### 10. Intended Use / Indications:

The Trinity™ Dual Mobility system is intended for use in the following indications:

- 1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis,
- Rheumatoid Arthritis, 2.
- 3. Correction of functional deformity,
- 4. Revision of previously failed total hip arthroplasty,
- Patients at increased risk of dislocation, 5.
- 6. Developmental dysplasia of the hip (DDH),

The TrinityTM Dual Mobility System is indicated for cementless use only.

#### 11. Summary of Technologies/Substantial Equivalence:

The Trinity™ Dual Mobility System is similar to the predicate devices (K110087, K111481, K150522 and K103233) in terms of intended use and indications, materials, sizes, design and testing. Based on these similarities, the Trinity™ Dual Mobility System is believed to be substantially equivalent to the predicate devices.

#### 12. Pyrogenicity Assessment:

Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits.

#### 13. Non-Clinical Testing:

Non-clinical testing conducted to demonstrate substantial equivalence includes static tests (Push-out, lever-out, torque-off) and Dynamic Tests (Impingement, corrosion, range of motion, and wear). The results of this testing show that the Trinity™ Dual Mobility System is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.

#### 14. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Trinity™ Dual Mobility System and the predicate devices.