(56 days)
The iTotal® Identity™ Cruciate Retaining (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. The CS insert option should be utilized when additional anterior-posterior constraint is desired.
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is a patient-specific tri-compartmental faceted knee replacement system. It is a posterior cruciate ligament retaining knee replacement system. It is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components. An optional Cruciate Sacrificing insert may be utilized when additional anterior-posterior constraint is desired.
Using patient imaging (CT 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 (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel cap manufactured from polyethylene (UHMWPE) and either one or two polyethylene inserts. The CS insert is a one-piece insert. The polyethylene inserts may be manufactured from either iPoly® (UHMWPE) or iPoly® XE (a Highly Cross-Linked, Vitamin-E Stabilized UHMWPE). The patellar component is provided in either a round or oval dome shape and may be manufactured from either iPoly® or iPoly® XE.
For user convenience, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal® Identity™ CR KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
The provided text is a 510(k) summary for the iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS), specifically focusing on the new Cruciate Sacrificing (CS) tibial insert. This document asserts substantial equivalence to existing predicate devices, rather than presenting a study proving that an AI/ML powered device meets acceptance criteria.
The information requested in the prompt (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in submissions for AI/ML-powered medical devices that perform tasks like image interpretation or diagnosis. This document, however, describes a mechanical medical device (a knee implant) and its component. The "performance data" section refers to engineering and biomechanical testing, not clinical performance or AI/ML model performance.
Therefore, I cannot extract the requested information from the provided text as it does not pertain to an AI/ML medical device. The document details the device's design, materials, sterilization, and basic performance testing for a physical implant, not an AI/ML algorithm.
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May 12, 2021
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Conformis, Inc. Mary Kruitwagen Sr. Regulatory Affairs Specialist 600 Technology Park Drive, Fourth Floor Billerica, Massachusetts 01821
Re: K210809
Trade/Device Name: iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OOG, OIY Dated: March 15, 2021 Received: March 17, 2021
Dear Mary Kruitwagen:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210809
Device Name
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
Indications for Use (Describe)
The iTotal® Identity™ Cruciate Retaining (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. The CS insert option should be utilized when additional anterior-posterior constraint is desired.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5: 510(k) Summary
The following 510(k) Summary is provided as per 21 CFR 807.92 requirements
| Subject Device: (Proprietary/Tradename): | iTotal® Identity™ Cruciate Retaining (CR) Knee ReplacementSystem (KRS) | |
|---|---|---|
| Common Usual Name: | Knee Replacement System | |
| Type of Submission: | Traditional 510(k) | |
| Device Class: | II | |
| Regulation Number: | 888.3560 | |
| Regulation Description: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis | |
| Primary Product Classification Codeand Description: | JWHKnee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis | |
| Secondary Product ClassificationsCode(s) and Description(s): | OOG, OIYKnee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis | |
| Reviewing Agency: | Orthopedics | |
| Date of Summary Preparation: | March 15, 2021 | |
| Submitter's Name and Address: | Conformis Inc. | |
| 600 Technology Park Drive | ||
| Fourth Floor | ||
| Billerica, MA 01821 | ||
| USA | ||
| Telephone Number: | (781) 345-9001 | |
| Establishment RegistrationNumber(s): | 30098446033004153240 | |
| Contact Name: | Mary Kruitwagen | |
| Contact Telephone: | 781-345-9038 | |
| Contact email: | Mary.Kruitwagen@conformis.com | |
| Alternate Contact: | Emmanuel Nyakako | |
| Alternate Contact Telephone: | 781-345-9164 | |
| Alternate Contact email: | Emmanuel.Nyakako@conformis.com | |
| Primary Predicate Device: | iTotal® Identity™ Cruciate Retaining (CR) Knee ReplacementSystem | |
| iTotal® Identity™ Posterior Sacrificing (PS) Knee Replacement | ||
| System | ||
| Primary Predicate Device 510(k): | K203447, December 22, 2020 | |
| Primary Predicate Device ProductClassification Code(s) andDescription(s): | JWH, OOG, OIYKnee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis | |
| Secondary Predicate Device: | iTotal® Identity™ Cruciate Retaining (CR) Knee ReplacementSystemiTotal® Identity™ Posterior Stabilized (PS) Knee ReplacementSystem | |
| Secondary Predicate Device 510(k):Secondary Predicate DeviceProduct Classification Code(s) andDescription(s): | K210252, February 18, 2021JWH, OOG, OIYKnee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis | |
| Reference Device:Reference Device 510(k):Reference Device ProductClassification Code(s) andDescription(s): | Stryker Orthopeadics Triathlon Total Knee SystemK173849, February 2, 2018MBH: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.,JWH: Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis | |
| Modification | This submission requests 510(k) clearance for the Cruciate Sacrificing (CS) tibialinsert utilized with iTotal® Identity™ Cruciate Retaining (CR) Total KneeReplacement System (KRS). This optional insert may be used when additionalanterior-posterior constraint is desired. Included in this submission are thecorresponding CS trials. | |
| Device Description | iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is apatient-specific tri-compartmental faceted knee replacement system. It is aposterior cruciate ligament retaining knee replacement system. It is a semi-constrained, cemented knee implant which consists of femoral, tibial, andpatellar components. An optional Cruciate Sacrificing insert may be utilizedwhen additional anterior-posterior constraint is desired.Using patient imaging (CT scans) and a combination of proprietary and off-the-shelf software, a patient-specific implant is designed that best meets thegeometric and anatomic requirements of the specific patient. The femoralcomponent is manufactured from cobalt chromium molybdenum (CoCrMo)alloy. The tibial component includes a metal tray and tray keel stem extensionmanufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel capmanufactured from polyethylene (UHMWPE) and either one or twopolyethylene inserts. The CS insert is a one-piece insert. The polyethyleneinserts may be manufactured from either iPoly® (UHMWPE) or iPoly® XE (aHighly Cross-Linked, Vitamin-E Stabilized UHMWPE). The patellar component isprovided in either a round or oval dome shape and may be manufactured fromeither iPoly® or iPoly® XE. |
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K210809 page 3 of 5
For user convenience, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal® Identity™ CR KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately. Indications for Use The iTotal® Identity™ Cruciate Retaining (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. The CS insert option should be utilized when additional anterior-posterior constraint is desired. Technological Intended Use/Indications for Use: Characteristics The proposed Cruciate Sacrificing (CS) tibial insert utilized with iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS), is indicated when the surgeon desires additional anterior-posterior constraint. This does not change the intended use of the device, only clarifies the purpose of the subject CS insert within the context of the Indications for Use. While the intended use of the device has not changed, the Indications for Use is modified to include the following statement: The CS insert option should be utilized when additional anterior-posterior constraint is desired. Operating Principal/Fundamental Technology: The proposed and predicate devices are semi-constrained, cemented knee implants that consist of three primary components; femoral, tibial, and patellar. Single-use, patient-specific ancillary surgical instruments are provided for use with both the predicate and proposed iTotal® Identity™ CR KRS to assist with surgical implantation. Reusable ancillary surgical instruments, provided in a reusable instrument tray, are used with the predicate and proposed devices. These instruments assist with surgical implantation.
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Design:
The proposed and predicate devices have the same basic design characteristics as they are comprised of three primary components: femoral, tibial, and patellar. The proposed Cruciate Sacrificing insert utilized with iTotal® Identity™ CR KRS offers an option when additional anterior-posterior constraint is desired.
Materials:
The femoral implant is CoCrMo alloy. The Tibial tray and stem are titanium alloy (Ti6AL4V-ELI) with the stem cap of UHMWPE. The tibial insert, including the subject insert, is iPoly® or iPoly® XE. The trials and ancillary single-use instruments are Nylon. Reusable ancillary surgical instruments are R-Radel or stainless steel.
Sterilization:
The subject and predicates devices are provided sterile utilizing Ethylene Oxide (EO) or Vaporized Hydrogen Peroxide Low Temperature Sterilant-Vacuum process.
Performance Data The following testing was conducted using the subject CS insert to verify that the device is substantially equivalent to the predicate iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS).
- Contact Area and Surface testing
- Constraint analysis
- Range of Motion
- Tibial interlock strength
- Cadaveric evaluation
Design validation was conducted under simulated use conditions. It consisted of cadaveric testing following the proposed surgical technique for the proposed iTotal® Identity™ CR KRS with CS Insert.
The test results demonstrated that the proposed iTotal Identity CR KRS is safe for its intended use and can be considered substantially equivalent to the predicate iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS).
Substantial The proposed Cruciate Sacrificing (CS) tibial insert utilized with iTotal® Identity™ Equivalence Cruciate Retaining (CR) Knee Replacement System (KRS), is indicated when the surgeon desires additional anterior-posterior constraint. While the intended use of the Knee Replacement System has not changed, the Indications for Use is modified to include the following statement: The CS insert option should be utilized when additional anterior-posterior constraint is desired. This statement does not change the intended use of the device, only clarifies the purpose of the subject CS insert within the context of the Indications for Use.
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K210809 page 5 of 5
The subject device, Cruciate Sacrificing (CS) tibial insert utilized with iTotal® ldentity™ Cruciate Retaining (CR) Knee Replacement System, is the same as the predicate device with regards to:
- Intended Use ●
- . operating principles
- femoral implant
- tibial implant
- . CR tibial insert
- patella component
- ancillary instruments and iJigs
- . design and methods of manufacture of the implants and instrumentation
- . packaging configurations
- performance characteristics
- . sterilization methods
- sterility assurance level (SAL) of 1x10-6
Conclusion Based on the intended use, technological characteristics, and outcome of the performance data the subject device, subject Cruciate Sacrificing (CS) tibial insert utilized with iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is substantially equivalent to the primary and secondary predicate device iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.