IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM

K132640 · Conformis, Inc. · HSX · Dec 5, 2013 · Orthopedic

Device Facts

• Record ID: K132640
• Device Name: IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Applicant: Conformis, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Dec 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ConforMIS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. Candidates for unicondylar knee replacement include those with: joint impairment due to osteoarthritis or traumatic arthritis of the knee; previous femoral condyle or tibial plateau fracture, creating loss of function; valgus or varus deformity of the knee; revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. This implant is intended for cemented use only.

Device Story

Patient-specific unicompartmental knee replacement system; consists of femoral and tibial components designed from patient MRI or CT scans. Proprietary software (SegSurf, iUniWorks, iUni FemJigs) analyzes patient images to create personalized implant geometry and disposable patient-specific instrumentation (Nylon jigs). Femoral implant made of CoCrMo alloy; tibial component either all-polyethylene (UHMWPE) or metal-backed (CoCrMo tray with UHMWPE insert). Used by orthopedic surgeons in clinical settings to replace damaged articular surfaces. Personalized design aims to match patient anatomy, potentially improving fit and function compared to off-the-shelf implants. Implants are cemented during surgery.

Clinical Evidence

Bench testing only. No clinical data was required to demonstrate substantial equivalence. Evidence consists of software verification and validation testing for the updated proprietary software modules (SegSurf v3.0, iUniWorks v4.0, iUni FemJigs v2.0).

Technological Characteristics

Patient-specific knee prosthesis. Materials: CoCrMo alloy (femoral/tibial tray), UHMWPE (tibial insert/all-poly component). Patient-specific instrumentation: Nylon jigs. Design derived from MRI/CT scan analysis via proprietary software. Cemented fixation. Software modules: SegSurf v3.0, iUniWorks v4.0, iUni FemJigs v2.0.

Indications for Use

Indicated for patients with knee joint impairment due to osteoarthritis, traumatic arthritis, previous femoral condyle or tibial plateau fracture, or valgus/varus deformity requiring unicondylar knee replacement. Also indicated for revision procedures if anatomic landmarks are identifiable on imaging. Contraindicated in patients without adequate healthy bone to support components.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• ConforMIS iUni Unicondylar Knee Replacement System (K121974)
• ConforMIS iUni Unicondylar Knee Replacement System (K111916)

Submission Summary (Full Text)

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#### 510(K) SUMMARY (PAGE 1 OF 4) 6.0

| Submitter's Name and Address: | ConforMIS Inc.<br>28 Crosby Drive<br>Bedford, MA 01730 |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3009844603 and 3004153240 |
| | DEC 0 5 2013 |
| Date of Summary: | August 21, 2013 |
| Contact Person: | Amita S. Shah, Sr. Vice President, Regulatory and Quality Affairs |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Name of the Device: | ConforMIS iUni Unicondylar Knee Replacement System (KRS) |
| Common Name: | Unicondylar Knee Replacement System |
| Regulatory Status and Regulation Number: | Class II<br>21 CFR 888.3520 |
| Classification Name: | <ul><li>HSX - Prosthesis, knee, femorotibial, nonconstrained, cemented, metal/polymer</li><li>OOG - Knee Arthroplasty Implantation System</li></ul> |
| Indications for Use: | The ConforMIS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components. |
| | Candidates for unicondylar knee replacement include those with: |
| | <ul><li>joint impairment due to osteoarthritis or traumatic arthritis of the knee</li><li>previous femoral condyle or tibial plateau fracture, creating loss of function</li><li>valgus or varus deformity of the knee</li><li>revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans</li></ul> |
| | This implant is intended for cemented use only. |
| Identification of the Legally Marketed Device (Predicate Device): | ConforMIS iUni Unicondylar Knee Replacement System (KRS)<br>Device Class: II<br>Product Code: HSX, OOG<br>Regulation Number: 21 CFR 888.3520<br>510(k) Number: K121974 and K111916 |

TradItional 510(k) – Modification of the iUni Knee Replacement System – SegSurf v3.0/iUniWorks v4.0/iUni FemJigs v2.0

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### 510(K) SUMMARY (PAGE 2 OF 4)

Device Description: ConforMIS iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni KRS is comprised of a set of implants designed from patient images. The implant system consists of: 1 Femoral Implant t . 1 Tibial Component (all-polyethylene or metal backed) The implants of the iUni KRS consists of individually packaged femoral and tibial components and are provided with ancillary instrumentation to assist in the implantation procedure. The patient-specific femoral implant is made of Cobalt Chrome Molybdenum alloy (CoCrMo) and is personalized to match a patient's anatomy. The all poly tibial component is made from UHMWPE. The metal backed tibial component consists of a CoCrMo tibial tray and with an Ultra High Molecular Weight Polyethylene (UHMWPE) tibial insert. Multiple inserts of varying thicknesses may be provided to accommodate surgeon preferences. The outline, the bone contacting surfaces, and the articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT scan. Disposable, patient-specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System. Substantial The product subject of this premarket notification is substantially Equivalence: equivalent to the iUni Unicondylar Knee Replacement System (K121974 cleared September 06, 2012 and K111916 cleared September 29, 2011. The following testing was performed to establish substantial equivalence:

Software verification and validation testing of

proprietary software

Traditional 510(k) - Modification of the iUni Knee Replacement System - SegSurf v3.0/iUniWorks v4.0/iUni FemJigs v2.0

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## K132640 (3/4)

# 510(K) SUMMARY (PAGE 3 OF 4)

### Device Comparison

| Characteristic | Predicate<br>iUni Unicondylar Knee Replacement System<br>(K121974 & K111916) | iUni Unicondylar Knee Replacement System<br>(This submission) |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The ConforMIS Unicondylar Knee<br>Replacement System (iUni) is intended for<br>use in one compartment of the<br>osteoarthritic knee to replace the damaged<br>area of the articular surface in patients with<br>evidence of adequate healthy bone<br>sufficient for support of the implanted<br>components. | The ConforMIS Unicondylar Knee<br>Replacement System (iUni) is intended for<br>use in one compartment of the<br>osteoarthritic knee to replace the damaged<br>area of the articular surface in patients with<br>evidence of adequate healthy bone<br>sufficient for support of the implanted<br>components. |
| | Candidates for unicondylar knee<br>replacement include those with:<br>• joint impairment due to osteoarthritis or<br>traumatic arthritis of the knee<br>• previous femoral condyle or tibial<br>plateau fracture, creating loss of<br>function and<br>• valgus or varus deformity of the knee<br>• revision procedures provided that<br>anatomic landmarks necessary for<br>alignment and positioning of the<br>implant are identifiable on patient<br>imaging scans<br>This implant is intended for cemented use<br>only. | Candidates for unicondylar knee<br>replacement include those with:<br>• joint impairment due to osteoarthritis or<br>traumatic arthritis of the knee<br>• previous femoral condyle or tibial<br>plateau fracture, creating loss of<br>function<br>• valgus or varus deformity of the knee<br>• revision procedures provided that<br>anatomic landmarks necessary for<br>alignment and positioning of the<br>implant are identifiable on patient<br>imaging scans<br>This implant is intended for cemented use<br>only. |
| Cement Use Only | Yes | Yes |
| Product<br>Classification | 21 CFR 888.3520 (HSX) | 21 CFR 888.3520 (HSX) |
| Components and<br>Materials | • Femoral Implant: CoCrMo<br>• Metal Backed Tibial Components:<br>o Tibial tray: CoCrMo<br>o Tibial Inserts: UHMWPE<br>• All-Polyethylene Tibial Component:<br>UHMWPE | • Femoral Implant: CoCrMo<br>• Metal Backed Tibial Components:<br>o Tibial tray: CoCrMo<br>o Tibial Inserts: UHMWPE<br>• All-Polyethylene Tibial Component:<br>UHMWPE |
| Design | Prosthesis, knee, femorotibial,<br>nonconstrained, cemented, metal/polymer | Prosthesis, knee, femorotibial,<br>nonconstrained, cemented, metal/polymer |
| Patient Matched | Yes | Yes |
| Instrumentation | Patient-specific Nylon jigs | Patient-specific Nylon jigs |
| Characteristic | Predicate<br>iUni Unicondylar Knee Replacement System.<br>(K121974 & K111916) | iUni Unicondylar Knee Replacement System<br>(This submission) |
| Proprietary<br>Software for<br>Segmenting and<br>Surfacing | SegSurf version 2.0 | SegSurf version 3.0 |
| Proprietary<br>Software for<br>Femoral<br>Components | iUniWorks version 3.0 | iUniWorks version 4.0 |
| Proprietary<br>Software for the<br>Femoral Trial | iUni FemJigs version 1.3 | iUni FemJigs version 2.0 |

Traditional 510(k) – Modification of the iUni Knee Replacement System – SegSurf v3.0iUniWorks v4.0

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# 510(K) SUMMARY (PAGE 4 OF 4)

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| Description and<br>Conclusion of<br>Testing: | Nonclinical Testing: The determination of substantial<br>equivalence for this device was based on a detailed device<br>description. The following non-clinical laboratory testing was<br>performed demonstrating that the device is safe and can be<br>considered substantially equivalent to the predicate device for<br>the intended use:<br>Detailed software description and software verification<br>and validation testing of proprietary software SegSurfDetailed software description and software verification<br>and validation testing of proprietary software iUniWorksDetailed software description and software verification<br>and validation testing of proprietary software iUni<br>FemJigs |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and<br>Performance: | The determination of substantial equivalence for this device was<br>based on a detailed device description. Non-clinical laboratory<br>testing was performed demonstrating that the device is safe and<br>can be considered substantially equivalent to the predicate<br>device for the intended use. Clinical data is not necessary to<br>demonstrate substantial equivalence. |
| Conclusion: | Based on the testing conducted it is concluded that the iUni<br>Unicondylar Knee Replacement System with the use of SegSurf<br>v3.0, iUniWorks v4.0, and iUni FemJigs v2.0 production<br>software modules is substantially equivalent to the iUni<br>Unicondylar Knee Replacement System (K121974 cleared<br>September 06, 2012 and K111916 cleared September 29, 2011. |

Traditional 510(k) – Modification of the iUni Knee Replacement System – SegSurf v3.0iUniWorks v4.0

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 5, 2013

ConforMIS, Incorporated Ms. Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts 01730

Re: K132640

Trade/Device Name: ConforMIS" iUni Unicondylar Knee Replacement System (iUni) Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint fomorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II. Product Code: HSX, OOG Dated: September 5, 2013 Received: September 9, 2013

Dear Ms. Shah:

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 10 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: CDRFI docs not evaluate information related to contract liability warrantics. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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. Amita Shah

device-related adverse events) (21 CFR 803); good manufacturing practive 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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/dcfault.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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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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### Indications for Use

510(k) Number (if known): K132640

### Device Name:

ConforMIS® iUni Unicondylar Knee Replacement System (iUni)

Indications for Use:

The ConforMIS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components.

Candidates for unicondylar knee replacement include those with:

- joint impairment due to osteoarthritis or traumatic arthritis of the knee .
- previous femoral condyle or tibial plateau fracture, creating loss of function .
- valgus or varus deformity of the knee .
- o revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant is intended for cemented use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Casey L. Hanley, Ph.D. |
|--------------------------------|
| Division of Orthopedic Devices |

Traditional 510(k) - Modification of the iUnl Knee Replacement System - SegSurf v3.0iUniWorks v4.0