Who is the manufacturer of ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM?

Conformis, Inc. filed the 510(k) submission for ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM (K133560).

What is the FDA product code for ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM?

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

What is the regulatory pathway for ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM?

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

What are the predicate devices for ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM?

ConforMIS iTotal CR Knee Replacement System (K131467); ConforMIS iTotal CR Knee Replacement System (K131019); ConforMIS iTotal CR Knee Replacement System (K122870).

Who can help prepare an FDA 510(k) submission like ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM?

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.

ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM

K133560 · Conformis, Inc. · JWH · Mar 28, 2014 · Orthopedic

Device Facts

Record ID	K133560
Device Name	ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
Applicant	Conformis, Inc.
Product Code	JWH · Orthopedic
Decision Date	Mar 28, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The iTotal® CR Knee Replacement System 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, patellofemoral or bicompartmental 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, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. • 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 tricompartmental cruciate-retaining knee replacement system; utilizes patient CT or MR imaging data; proprietary and off-the-shelf software designs implants to match patient-specific geometry/anatomy. Femoral component manufactured via additive manufacturing (powdered CoCr alloy); tibial component features metal tray (CoCr) and UHMWPE or Vitamin E-infused highly cross-linked polyethylene inserts; patellar component made of UHMWPE or Vitamin E-infused highly cross-linked polyethylene. System includes patient-specific nylon surgical jigs for intra-operative bone cutting and component positioning. Used in clinical settings by orthopedic surgeons for cemented total knee arthroplasty. Benefits include improved anatomical fit through patient-specific design. Ancillary instruments are single-use and sterile.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing only, including material, mechanical, biocompatibility, fatigue, and contact stress/area testing.

Technological Characteristics

Patient-specific cemented knee prosthesis. Femoral component: CoCr alloy (additive manufacturing). Tibial component: CoCr tray with UHMWPE or Vitamin E-infused highly cross-linked UHMWPE inserts. Patellar component: UHMWPE or Vitamin E-infused highly cross-linked UHMWPE. Fixed-bearing design. Sterilization: VHP Gas Plasma. Software: Proprietary and off-the-shelf for patient-specific design.

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, moderate varus/valgus/flexion deformity, or failed prior partial/hemi-arthroplasty/osteotomy. Contraindicated for conditions treatable by partial/bicompartmental implants or where anatomic landmarks are unidentifiable.

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 (K131467)
ConforMIS iTotal CR Knee Replacement System (K131019)
ConforMIS iTotal CR Knee Replacement System (K122870)

Related Devices

K152704 — iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System · Conformis, Inc. · Oct 21, 2015
K190562 — iTotal Identity Cruciate Retaining Knee Replacement System · Conformis, Inc. · Aug 8, 2019
K140833 — ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM · Conformis, Inc. · Jun 30, 2014
K131019 — ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM · Conformis, Inc. · May 24, 2013
K122033 — ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM · Conformis, Inc. · Sep 27, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ ## 6.0 510(K) SUMMARY # MAR 2 8 2014 | Submitter's Name and Address | ConforMIS Inc. 28 Crosby Drive Bedford, MA 01730 | |-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number | 3004153240 3009844603 | | Date of Summary | November 19, 2013 | | Contact Person | Amita S. Shah, Senior Vice President, Regulatory and Quality Affairs | | Telephone Number | (781) 345-9164 | | Fax Number | (781) 345-0147 | | Name of the Device | ConforMIS iTotal® Cruciate Retaining Knee Replacement System | | Common or Usual Name | Cruciate Retaining Total Knee Replacement System | | Classification Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis | | Regulation Number | 21 CFR 888.3560 | | Device Classification | Product Code: JWH - Prosthesis, Knee, Patellofemorotibial, Semi-Contrained, Cemented, Polymer/Metal/Polymer OIY - Prosthesis, Knee, Patellofemorotibial, Semi-Contrained, Cemented, Polymer + Additive/Metal/Polymer +Additive OOG - Knee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis. Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components. | | 510(k) Summary continued | | | Indications for Use | The iTotal® CR Knee Replacement System 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, patellofemoral or bicompartmental 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, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. • 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 | | Identification of the Legally Marketed Devices (Predicate Devices) | ConforMIS iTotal CR Knee Replacement System (KRS) Device Class: II Product Code: JWH, OOG, OIY Regulation Number: 21 CFR 888.3560 510(k) number: K131467, K131019, K122870 | | 510(k) Summary continued | | | Device Description | The iTotal Cruciate Retaining 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. | | | Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCr) alloy. The tibial component includes a metal tray manufactured from CoCr alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or a highly cross-linked Vitamin E infused polyethylene (iPoly XE™) The patellar component is also manufactured from either UHMWPE or from a | | | highly cross-linked Vitamin E infused polyethylene (iPoly XE). | | | 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 cutting of bone. | | | The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate iTotal CR 510(k)s (K131467, K131019 and K122870). | | 510(k) Summary continued | | | Substantial Equivalence | The product subject of this premarket notification is substantially equivalent in design and functionality to the iTotal Cruciate Retaining Knee Replacement System (K131467 cleared July 18, 2013, K131019 cleared May 24, 2013, and K122870 cleared January 14, 2013). The proposed femoral components will be manufactured by an additive manufacturing process using CoCr alloy in a powdered form. The following non-clinical laboratory testing was performed to determine substantial equivalence: Material properties of CoCr implants manufactured by an additive manufacturing process Mechanical properties testing Physical properties testing Biocompatibility Testing of implants manufactured by the additive manufacturing process Performance testing of femoral implants manufactured through the additive manufacturing process Fatigue testing Contact stress/area testing All testing has demonstrated the device is substantially equivalent to the predicate devices. | {1}------------------------------------------------ {2}------------------------------------------------ . {3}------------------------------------------------ . {4}------------------------------------------------ ### 510(k) Summary continued: Device Comparison | Characteristic | iTotal CR KRS with femoral component manufactured via an additive manufacturing process (This submission) | Predicate iTotal CR KRS (K131467, K131019 and K122870) | |-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | The iTotal® CR Knee Replacement System 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, patellofemoral or bicompartmental 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. hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans | The iTotal® CR Knee Replacement System 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, patellofemoral or bicompartmental 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, hemiarthroplasties, and unicondylar, patellofemoral or bi-compartmental implants. Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans | | | The implant is intended for cemented use only | The implant is intended for cemented use only | | Intended for Cemented Use Only | Yes | Yes | | Product Classification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) | | Design | Knee joint patellofemorotibial semi -constrained cemented prosthesis | Knee joint patellofemorotibial semi -constrained cemented prosthesis | | Tibial Implant | Configuration: Metal Backed Tibial Implant Tibial Insert UHMWPE or Vitamin E infused highly cross-linked UHMWPE Single or Dual inserts Insert sizes:6-16mm Profile: patient specific | Configuration: Metal Backed Tibial Implant Tibial Insert UHMWPE or Vitamin E infused highly cross-linked UHMWPE Single or Dual inserts Insert sizes: 6-16mm Profile: patient specific | | Femoral Implant | CoCr - cast, wrought or additive manufacturing process Patient specific | CoCr - cast or wrought material Patient specific | | Patella Implant | UHMWPE or Vitamin E infused highly cross-linked UHMWPE | UHMWPE or Vitamin E infused highly cross-linked UHMWPE | | Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs | | Principle of Operation | Cemented use Fixed Bearing Design | Cemented use Fixed Bearing Design | | Posterior Cruciate Ligament (PCL) Sparing | Yes | Yes | | Patient-Matched | Yes | Yes | | Packaging | Device components are individually double pouched using Tyvek® /film pouches which are sealed and labeled | Device components are individually double pouched using Tyvek® /film pouches which are sealed and labeled | | Sterility Method/ Assurance Level | VHP Gas Plasma 1x10-6 | VHP Gas Plasma 1x10-6 | | Initial Shelf-Life | 6 months | 6 months | | Labeled Non-pyrogenic | No | No | {5}------------------------------------------------ {6}------------------------------------------------ ・ | 510(k) Summary continued | | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description and Conclusion of Testing | The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. Testing on the femoral components manufactured from an additive manufacturing process is outlined below: • Material properties tests • Mechanical properties testing • Biocompatibility tests • Contact area/contact stress testing • Fatigue testing of femoral implant Test results demonstrated that the device is safe and can be considered substantially equivalent to the predicate device for the intended use. | | Safety and Performance | The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. The testing demonstrated that the device is safe for its intended use and can be considered substantially equivalent to the predicate devices. 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 femoral components made from an additive manufacturing process is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System (K131467, K131019 and K122870) | {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is black and the background is white. March 28, 2014 ConforMIS, Incorporated Amita Shah Senior Vice President, Regulatory and Quality Affairs 28 Crosby Drive Bedford, Massachusetts, USA Re: K133560 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 Prosthesis Regulatory Class: Class II Product Code: JWH, OIY, OOG Dated: March 3, 2014 Received: March 4, 2014 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {8}------------------------------------------------ #### 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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 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/ResourcesforYou/Industry/default.htm. Sincerely yours, ## Lori A. Wiggins - for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ #### Indications for Use 510(k) Number (if known): _K133560 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 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, patellofemoral or bicompartmental 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, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. - 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 | 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 | Casey L. Hanley, Ph.D | |--------------------------------| | Division of Orthopedic Devices | Traditional 510(k) - Modified iTotal® CR KRS - Additive manufacturing