Corin Optimized Positioning System (OPS)

K152893 · Corin USA · LZO · Jun 3, 2016 · Orthopedic

Device Facts

• Record ID: K152893
• Device Name: Corin Optimized Positioning System (OPS)
• Applicant: Corin USA
• Product Code: LZO · Orthopedic
• Decision Date: Jun 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2

Intended Use

The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X- rays and CT imaging scans. The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty. The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches. The Patient Specific Guides are intended for single use only.

Device Story

System assists surgeons in total hip arthroplasty by providing patient-specific acetabular cup alignment. Inputs: preoperative X-rays and CT scans. Software processes images to generate Functional Hip Analysis (FHA) and Patient Specific Visualisation (PSV) reports; determines target orientation. Hardware: patient-specific single-use guides and bone model replicas of the patient's acetabulum; used with reusable instrumentation. Surgeon uses guides intra-operatively to orient the acetabular cup based on pelvic landmarks. Used in clinical settings for Direct Anterior or Posterolateral approaches. Benefits: improved accuracy of component placement relative to preoperative plan.

Clinical Evidence

No clinical data. Bench testing included biocompatibility, mechanical performance (drop, flexural creep), cleaning/sterilization validation, and software verification/validation. A cadaver study assessed system repeatability and reproducibility, confirming accuracy of implanted cup orientation relative to the preoperative plan.

Technological Characteristics

System comprises software and hardware (patient-specific guides, bone models, reusable instruments). Software performs preoperative analysis for acetabular cup orientation. Guides are single-use; reusable instruments undergo cleaning/sterilization. Biocompatibility per ISO 10993. Software validation per FDA guidance.

Indications for Use

Indicated for patients undergoing total hip arthroplasty requiring acetabular cup orientation assistance via patient-specific surgical instruments using preoperative X-ray and CT imaging.

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

• Materialise N.V. Signature™ Personalized Patient Care System (K111863)
• Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343, K131647)
• Corin Instrument 510(k) Exempt (Product Code KIL)
• Medacta Pedicle Screw Placement Guides (K132788)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2016

CORIN USA Kathy Trier, Ph.D. Global VP Regulatory and Clinical Affairs 5670 West Cypress Street, Suite C Tampa, Florida 33607

Re: K152893 Trade/Device Name: Corin Optimized Positioning System (OPS) 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, LWJ Dated: April 26, 2016 Received: April 27, 2016

Dear Dr. Trier:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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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# 2. INDICATIONS FOR USE

510(k) Number (if known): _K152893

Device Name: Corin Optimized Positioning System (OPS)

Indications for Use:

The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X- rays and CT imaqing scans.

The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches.

The Patient Specific Guides are intended for 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)

Page 1 of 1

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# 2. 510(K) SUMMARY

| 1. Applicant/Sponsor:<br>Distributor | Corin USA<br>5670 W. Cypress<br>Street Suite C<br>Tampa, Florida 33607<br>Establishment Registration No.: 1056629 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Manufacturer: | Optimized Ortho Pty Ltd<br>17 Bridge Street<br>Pymble NSW 2073<br>Australia<br>Establishment Registration No: None |
| 3. Contact Person: | Kathy Trier<br>Global VP Regulatory and Clinical Affairs<br>Corin USA<br>[phone]<br>[e-mail]<br><br>Diana Nader-Martone<br>Regulatory Affairs Associate<br>Corin USA<br>813-977-4469<br>[e-mail] |
| 4. Date: | April 21st 2016 |
| 5. Proprietary Name: | Corin Optimized Positioning System (OPS) |
| 6. Common Name: | Hip Prosthesis |
| 7. Product Code(s): | LZO, MEH, LWJ |

## 8. Classification Name:

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

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

- · Materialise N.V. Signature™ Personalized Patient Care System (K111863)
- Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343, K131647)
- · Corin Instrument 510(k) Exempt (Product Code KIL)
- Reference Predicate Device Medacta Pedicle Screw Placement Guides (K132788)

## 10. Device Description:

The Corin Optimized Positioning System (OPS) consists of software and hardware components to assist the surgeon in the alignment of components during Total Hip Arthroplasty.

The software component assists the surgeon in determining a patient specific target orientation for the acetabular cup through a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.

The hardware components assist the surgeon in delivering the target orientation through the use of a Patient Specific Guide and bone model (replica of the patient's acetabulum, into which the guide fits), and associated reusable instrumentation.

The Corin OPS can be used with the Trinity Acetabular System and the respective compatible components.

## 11. Intended Use / Indications:

The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X- rays and CT imaging scans.

The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches.

The Patient Specific Guides are intended for single use only.

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#### 12. Non-Clinical Testing:

Non-clinical testing was performed to assess the safety and effectiveness of the device. Testing included biocompatibility testing of the raw material performed by the raw material supplier according to ISO 10993. Mechanical and performance testing was also performed on the Patient Specific Guides to ensure that the devices are able to withstand the conditions that may be encountered during storage, shipping, distribution and normal use including drop testing for damage or fracture, flexural creep, cleaning and sterilization, packaging and shelf life validation. A cadaver study was performed to measure the repeatability (intra-observer variability) and reproducibility (inter-observer variability) of the system to verify the performance of the system was adequate to perform as intended and to assure the system accuracy of implanted cup orientation relative to the pre-operative plan. Software verification and validation was completed in accordance with FDA guidance including General Principles of Software Validation; Final Guidance for Industry and FDA Staff and Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices. Testing was also performed to verify that the FHA software module and acetabular quide design is reproducible and repeatable when processed by multiple operators. Cleaning and sterilization validation of the re-usable instruments was completed. Testing verified that the accuracy and performance of the device is adequate to perform as intended.

#### 13. Clinical Testing:

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

## 14. Summary of Technologies/Substantial Equivalence:

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