Corin Optimized Positioning System (OPS) Femoral

K181061 · Corin USA · LZO · Sep 7, 2018 · Orthopedic

Device Facts

• Record ID: K181061
• Device Name: Corin Optimized Positioning System (OPS) Femoral
• Applicant: Corin USA
• Product Code: LZO · Orthopedic
• Decision Date: Sep 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement. The Corin OPS™ Femoral is intended to be used with the Corin OPS™ Plan (K171847) and the compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral Guide is intended for use with the direct anterior surgical approach. The Corin OPS™ Femoral PSI is intended for single use only.

Device Story

Corin OPS Femoral comprises patient-specific instruments (PSI) including femoral guides and optional trial femoral heads; used during total hip arthroplasty. Device utilizes pre-operative plan (K171847) derived from patient CT scans and AP X-rays to define target femoral neck osteotomy. Surgeon uses shape-matched femoral guide to execute planned resection. Dislocating guide supports posterolateral approach; in-situ guide supports direct anterior approach. System assists surgeon in achieving precise implant sizing and placement based on anatomical landmarks. Benefits include improved surgical accuracy for femoral neck osteotomy. Device is single-use; intended for clinical setting.

Clinical Evidence

No clinical data. Bench testing only. Testing included quantitative assessments of clinical accuracy, biocompatibility, and dimensional stability. Packaging, distribution, cleaning, and sterilization validation were completed.

Technological Characteristics

Patient-specific femoral guides; shape-matched to patient anatomy. Single-use. Materials and performance characteristics equivalent to predicate devices. Used in conjunction with pre-operative planning software (K171847).

Indications for Use

Indicated for patients undergoing total hip arthroplasty requiring assistance with femoral neck osteotomy via patient-specific surgical instruments.

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

• Corin Optimized Positioning System (OPS) (K152893)
• Stryker Triathlon Knee System (K141056)

Reference Devices

• Corin OPS Plan (K171847)

Submission Summary (Full Text)

{0}------------------------------------------------

September 7, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Corin USA % Crissy Tomarelli Clinical, Regulatory and Quality Affairs Manager Corin (Australia) 17 Bridge Street Sydney, 2073 Australia

#### Re: K181061

Trade/Device Name: Corin Optimized Positioning System (OPS) Femoral 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, LWJ, MEH, PBF Dated: August 6, 2018 Received: August 8, 2018

## Dear Ms. Tomarelli:

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. 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 located 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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K181061

Device Name

Corin Optimized Positioning System (OPSTM) Femoral

Indications for Use (Describe)

The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement.

The Corin OPS™ Femoral is intended to be used with the Corin OPS™ Plan (K171847) and the compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral Guide is intended for use with the direct anterior surgical approach.

The Corin OPSTM Femoral PSI is intended for single use only.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

#### 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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."

{3}------------------------------------------------

______________________________________________________________________________________________________________________________________________________________________________

| 1. | Applicant/Sponsor<br>Distributor: | Corin USA Limited<br>Distributor<br>12750 Citrus Park Lane<br>Suite 120<br>Tampa, Florida 33625<br>Establishment Registration No.: 1056629 | |
|----|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 2. | Manufacturer: | Optimized Ortho Pty Ltd<br>17 Bridge Street<br>Pymble NSW<br>2073 Australia<br>Establishment Registration No: 3012916784 | |
| 3. | Contact Person: | Crissy Tomarelli<br>Clinical, Regulatory and Quality Affairs<br>Manager<br>Corin (Australia) Pty Limited<br>[e-mail]<br>Lucinda Gerber<br>Global Regulatory Affairs Manager<br>Corin USA Limited<br>1 [phone]<br>[e-mail] | |

- 4. Date: April 20, 2018
- 5. Trade Name: Corin Optimized Positioning System (OPS™) Femoral
- 6. Common Name: OPS™ Femoral
- 7. Classification Product Code(s): LZO, LWJ, MEH

{4}------------------------------------------------

## 8. Classification Name:

21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

21 CFR 888.3030 - Orthopaedic Surgical Planning And Instrument Guides.

# 9. Substantially Equivalent (predicate) device(s):

- . Corin Optimized Positioning System (OPS) (K152893)
- . Stryker Triathlon Knee System (K141056)

# 10. Device Description:

The Corin Optimized Positioning System (OPS™) Femoral consists of Femoral Patient Specific Instruments (PSI) and reusable instrumentation. The Femoral Patient Specific Instruments include a Femoral Guide and an optional Trial Femoral Head (Bone Model).

The Femoral Guide is shape-matched to the patient's femoral anatomy and provides a guide for the femoral neck osteotomy during total hip arthroplasty. The planned femoral resection, or target osteotomy, is defined by the previously cleared OPS™ Plan (K171847). The OPS™ Plan is a pre-operative tool used by the Surgeon for the selection, sizing and placement of implant components using anatomical landmarks of the femur and pelvis identified from pre-operative CT scan and AP X-ray. The OPS™ Plan was previously cleared under K171847 and is not submitted for review in this 510k submission.

# 11. Indications for Use / Intended Purpose:

The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement.

The Corin OPS™ Femoral is intended to be used with the Corin OPS™ Plan (K171847) and the compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral Guide is intended for use with the direct anterior surgical approach.

{5}------------------------------------------------

The Corin OPS™ Femoral PSI is intended for single use only.

# 12. Summary of Technologies/Substantial Equivalence:

Device comparison showed that the proposed device is substantially equivalent in intended use, technology, material and performance characteristics to the predicate devices.

## 13. Non-Clinical Testing:

Non-clinical testing was performed to assess the safety and effectiveness of the device.

Testing included quantitative assessments of clinical accuracy, biocompatibility and dimensional stability. Packaging, distribution, cleaning and sterilization validation of the OPS™ Femoral PSI was completed.

Testing verified that the accuracy and performance of the device is adequate to perform as intended.

## 14. Clinical Testing:

Clinical testing was not necessary for this Traditional 510(k).

#### 15. Conclusion:

The subject device has similar intended uses and indications, and technological characteristics, and material as its predicate devices. The differences between the device and its predicate devices raise no new issues in terms of safety or effectiveness.