Who is the manufacturer of CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)?

Conformis, Inc. filed the 510(k) submission for CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) (K120068).

What is the FDA product code for CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)?

JWH. It is classified under 21 CFR 888.3560 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)?

ConforMIS iTotal CR Knee Replacement System (K094050); ConforMIS iTotal CR Knee Replacement System (K103117); ConforMIS iTotal CR Knee Replacement System (K112780).

Who can help prepare an FDA 510(k) submission like CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)

K120068 · Conformis, Inc. · JWH · Feb 3, 2012 · Orthopedic

Device Facts

Record ID	K120068
Device Name	CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)
Applicant	Conformis, Inc.
Product Code	JWH · Orthopedic
Decision Date	Feb 3, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The iTotal® CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis. The indications for use include : Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants. The iTotal CR KRS is intended for cemented use only.

Device Story

Patient-specific, tricompartmental, posterior cruciate ligament (PCL) retaining, semi-constrained cemented knee replacement system. Inputs: patient CT or MR imaging. Processing: proprietary software (iTotal FemJigs v1.0) designs patient-specific implants and manual surgical instrumentation (Nylon jigs) to match patient anatomy. Outputs: custom femoral, tibial, and patellar components; patient-specific surgical guides. Used in clinical settings by orthopedic surgeons for total knee arthroplasty. Benefits: bone-preserving approach with minimal resection; improved anatomical fit via patient-specific design. Healthcare providers use the system to restore joint function and stability in patients with severe knee disease.

Clinical Evidence

No clinical data. Substantial equivalence established via device description and non-clinical software verification and validation testing.

Technological Characteristics

Materials: CoCrMo alloy (femoral/tibial tray), UHMWPE (tibial inserts/patellar component). Design: Patient-specific, tricompartmental, PCL-retaining, semi-constrained, cemented. Instrumentation: Patient-specific Nylon jigs. Software: Proprietary design software (iTotal FemJigs v1.0). Sterilization: Ancillary instruments provided sterile.

Indications for Use

Indicated for patients with knee joint pain and disability requiring total knee replacement due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, osteonecrosis, post-traumatic loss of function, or failed prior partial/hemi-arthroplasty/osteotomy. Suitable for patients with moderate varus, valgus, or flexion deformity where ligamentous structures can be stabilized.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

ConforMIS iTotal CR Knee Replacement System (K094050)
ConforMIS iTotal CR Knee Replacement System (K103117)
ConforMIS iTotal CR Knee Replacement System (K112780)

Related Devices

K122033 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM · Conformis, Inc. · Sep 27, 2012
K122991 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM · Conformis, Inc. · Dec 20, 2012
K140423 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM · Conformis, Inc. · May 27, 2014
K153721 — iTotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · Mar 25, 2016
K180906 — Conformis iTotal Cruciate Retaining (CR) Knee Replacement System · Conformis, Inc. · May 16, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ אילי )&oldid=120068 ... # FEB - 3 2012 . ### 5.0 510(K) SUMMARY | Submitter's Name and Address | ConforMIS Inc. 11 North Ave. Burlington, MA 01803 | |------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number | 3004153240 | | Date of Summary | January 4, 2012 | | Contact Person | Amita S. Shah, Vice President, Quality Assurance and Regulatory Affairs | | Telephone Number | (781) 345-9164 | | Fax Number | (781) 345-0104 | | Name of the Device | ConforMIS iTotal® CR Knee Replacement System (KRS) | | Common or Usual Name | Cruciate Retaining Total Knee Replacement System | | Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis | | Indications for Use | The iTotal® CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis. The indications for use include : <ul><li>Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.</li><li>Post traumatic loss of joint function.</li><li>Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.</li><li>Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants.</li></ul> The iTotal CR KRS is intended for cemented use only. | | Identification of the Legally Marketed Device (Predicate Device) | ConforMIS iTotal CR Knee Replacement System (KRS) Device Class: II Product Code: JWH, OOG Regulation Number: 21 CFR 888.3560 510(k) number: K094050, K103117 and K112780 | {1}------------------------------------------------ ## 510(k) Summary continued | Device Description | The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patient-specific implant and related instrumentation are designed, that best meet the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE. | | | For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510k i.e. K094050, K103117 and K112780. | | Substantial Equivalence: | The product subject of this premarket notification is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K094050 cleared September 16, 2010, K103117 cleared January 7, 2011, K112780 cleared December 15, 2011). The following testing was performed to establish substantial equivalence: Software verification and validation testing of proprietary software | {2}------------------------------------------------ K1200681314 #### 510(k) Summary continued ### Device Comparison | | Predicate iTotal CR Knee Replacement System (K112780) | Modified Device iTotal CR Knee Replacement System (This submission) | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Components | • Femoral Component • Tibial Implant • Metal Backed Tibial Component • Patellar component | • Femoral Component • Tibial Implant • Metal Backed Tibial Component • Patellar component | | Materials | • Femoral Implant: CoCrMo • Metal Backed Tibial Components: o Tibial tray: CoCrMo o Tibial Inserts: UHMWPE • All Polymer Patellar Component: UHMWPE | • Femoral Implant: CoCrMo • Metal Backed Tibial Components: o Tibial tray: CoCrMo o Tibial Inserts: UHMWPE • All Polymer Patellar Component: UHMWPE | | Design | Knee joint patellofemorotibial semi-constrained cemented prosthesis | Knee joint patellofemorotibial semi-constrained cemented prosthesis | | Principle of Operation | Cemented Use fixed Bearing Design | Cemented Use fixed Bearing Design | | Patient Matched | Yes | Yes | | Patellar Design/ Dimensions | Symmetrical, offered in various sizes | Symmetrical, offered in various sizes | | Minimum Thickness Tibial Insert (UHMWPE) | 6 mm | 6 mm | | Posterior Cruciate Ligament (PCL) Sparing | Yes | Yes | | Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs | | Proprietary Software for femoral iJig instrumentation | N/A -manual process | iTotal FemJigs version 1.0 | {3}------------------------------------------------ #### 510(k) Summary continued | Description and Conclusion of Testing | Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description. The following non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the intended use: • Detailed software description and software verification and validation testing of proprietary software | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Safety and Performance | The determination of substantial equivalence for this device was based on a detailed device description. Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the intended use. Clinical data is not necessary to demonstrate substantial equivalence. | | Conclusion: | Based on the testing conducted it is concluded that the iTotal Cruciate Retaining Knee Replacement System with the use of the iTotal FemJigs manufacturing software is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K094050 cleared September 16, 2010, K103117 cleared January 7, 2011 and K112780 cleared Dec 15, 2011. | : {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ConforMIS. Incorporated % Ms. Amita S. Shah Vice President, Quality Assurance and Regulatory Affairs 11 North Avenue Burlington, Massachusetts 01803 FEB - 3 2012 Re: K120068 Trade/Device Name: iTotal CR Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: Class II Product Code: JWH, OOG Dated: January 4, 2012 Received: January 9, 2012 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 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {5}------------------------------------------------ Page 2 - Ms. Amita Shah 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Erich Keith Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### Indications for Use # 510(k) Number (if known): K120068 Device Name: iTotal CR Knee Replacement System Indications for Use: The iTotal® CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee ioint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis. The indications for use include: - Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or . osteonecrosis of the knee. - Post traumatic loss of joint function. . - Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability. - Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-. compartmental implants. The iTotal CR KRS is intended for cemented use only. Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) . (Division Sign Off) (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices CR Knee Replacement System - iTotal FemJigs