(78 days)
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, 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 implant is intended for cemented use only.
The proposed iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tri-compartmental 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), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The device 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.
This document is a 510(k) Summary for the ConforMIS iTotal CR Knee Replacement System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing "acceptance criteria" and "device performance" in the traditional sense of a study with numerical performance metrics.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" and "reported device performance" in terms of numerical thresholds or metrics. Instead, "substantial equivalence" is the overarching acceptance criterion, demonstrated by comparing the modified device's characteristics and performance to a predicate device.
| Characteristic | Modified iTotal CR KRS (This submission) | Predicate iTotal CR KRS (K094050) | "Acceptance Criteria" (Substantial Equivalence) | "Reported Device Performance" (Comparison Result) |
|---|---|---|---|---|
| Indications for Use | Same as predicate | Total knee replacement for painful joint disease, post-traumatic loss of function, moderate deformity, failed osteotomies, hemiarthoplasties, unicondylar, patello-femoral or bi-compartmental implants. Intended for cemented use only. | Must be the Same | Same |
| Intended for Cement Use Only | Yes | Yes | Must be the Same | Same |
| Components | Femoral Component, Metal Backed Tibial Component, Patellar Component | Same | Must be the Same | Same |
| Materials | Femoral Implant- CoCrMo; Metal-Backed Tibial Components: Tibial tray- CoCrMo; Tibial Insert-UHMWPE; Patellar Component: UHMWPE | Same | Must be the Same | Same |
| Design - Knee joint type | Patellofemorotibial semi-constrained cemented prosthesis | Same | Must be the Same | Same |
| Design - Configuration | ||||
| Femoral Implant | Constant coronal curvature, Femoral cuts (distal, anterior, anterior chamfer, posterior, posterior chamfer) | Same | Must be the Same | Same |
| Tibial Implant | Metal Backed Tibial Implant; Single or Dual inserts; Insert sizes: 6-16mm; Articulating Surface: Curved; Profile: patient specific; Tray interlock: Interference fit Anterior lip Tray undercut design | Metal Backed Tibial Implant; Single or Dual inserts; Insert sizes: 6-16mm; Articulating surface: Curved; Profile: patient specific; Tray interlock: Interference fit No Anterior lip Tray pocket design | Must be substantially equivalent | Minor difference in tray interlock design, deemed substantially equivalent |
| Patellar Implant | Symmetrical, sizes 32, 35, 38, 41 mm; heights 6, 7, 8.5, 10 mm | Same | Must be the Same | Same |
| Principle of Operation | Cemented use, Fixed Bearing Design | Same | Must be the Same | Same |
| Posterior Cruciate Ligament (PCL) Sparing | Yes | Yes | Must be the Same | Same |
| Patient-Matched | Yes | Yes | Must be the Same | Same |
| Packaging | Device components individually double pouched using Tyvek/film pouches, sealed and labeled | Same | Must be the Same | Same |
| Non-clinical Performance | Tibiofemoral contact area/contact stress testing, Modular assembly and disassembly testing, Constraint testing | Not explicitly detailed for predicate, but testing performed to establish equivalence. | Safe and equivalent to predicate | Demonstrated through non-clinical testing |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical laboratory testing" but does not specify a "test set sample size" in terms of patients or a specific dataset. It also does not provide information on data provenance (country of origin, retrospective/prospective) as the submission relies on engineering and material testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this 510(k) submission. The "ground truth" here is the established safety and effectiveness of the predicate device, and the "experts" involved would be the engineers and scientists conducting the non-clinical tests to compare the new device to the predicate. There's no mention of medical experts establishing ground truth for a test set in the context of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in clinical studies involving human readers or evaluators, which is not the primary focus of this substantial equivalence submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in this document. The device is a physical knee replacement system, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this substantial equivalence submission is the established safety and effectiveness of the predicate device (iTotal CR KRS K094050) through its prior FDA clearance. The modified device's equivalence is demonstrated through engineering and material testing, showing "design, material intended use and function" are either identical or appropriately similar to the predicate.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of an AI/algorithm. For the physical device, manufacturing processes would be validated, but that's different from a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned in the document.
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ConforMIS iTotal CR Knee Repair System
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JAN - 7 2011
510(K) SUMMARY
This 510(k) Summary for the ConforMIS iTotal® Cruciate Retaining (CR) Knee Replacement System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Nameand Address: | ConforMIS Inc.2 Fourth Ave.Burlington, MA 01804 |
|---|---|
| Contact Person: | Amita S. Shah, Director, Quality Assurance and Regulatory Affairs |
| Date: | October 20, 2010 |
| Name of MedicalDevice: | Device Regulation: 21 CFR 888.3560 |
| Product Code: JWH, Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis | |
| Common/Usual Name: Cruciate Retaining Total Knee ReplacementSystem | |
| Proprietary Name: ConforMIS iTotal Cruciate Retaining KneeReplacement System | |
| DeviceClassification: | Class II |
| In accordance with per 21 CFR 888.3560, a knee joint | |
| patellofemorotibial polymer/metal/polymer non-constrained cementedprosthesis is classified by the FDA as a Class II Medical Device. | |
| Indications for Use: | The iTotal® CR Knee Replacement System is intended for use as a totalknee replacement in patients with knee joint pain and disability whoseconditions cannot be solely addressed by the use of a prosthetic devicethat treats only one or two of the three knee compartments, such as aunicondylar, patello-femoral or bi-compartmental prosthesis. Theindications 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 theligamentous structures can be returned to adequate function andstability.• Failed osteotomies, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants.The implant is intended for cemented use only. |
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ConforMIS iTotal CR Knee Repair System
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VID311
22/06/10
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| DeviceDescription: | The proposed iTotal CR Knee Replacement System (hereafter referredto as the "iTotal CR KRS") is a patient specific tri-compartmental facetedposterior cruciate ligament (PCL) retaining knee replacement system.The iTotal CR KRS is a semi-constrained cemented knee implant whichconsists of a femoral, tibial and patellar component. The product designincorporates a bone preserving approach with minimal bone resection ofthe tibia and femur for the treatment of severe pain and/or disability of aknee damaged by osteoarthritis or trauma.Using patient imaging (either CT or MR scans), a patient-specific implantis designed that best meets the geometric and anatomic requirements ofthe specific patient. The device is manufactured from cobalt chromiummolybdenum ("CoCrMo") alloy. The tibial component includes a metaltray manufactured from CoCrMo alloy and either one or twopolyethylene inserts manufactured from UHMWPE of identicalconfiguration. The patellar component is manufactured from UHMWPE. |
|---|---|
| SubstantialEquivalence: | The product subject of this premarket notification is substantiallyequivalent to the iTotal Cruciate Retaining Knee Replacement System(K094050 cleared September 16, 2010) and other currently marketed,cemented total knee replacement systems. The following testing wasperformed to establish substantial equivalence:Tibiofemoral contact area/contact stress testing Modular assembly and disassembly testing of the tibial tray/insert Constraint testing The proposed iTotal CR KRS has the same technological characteristicsi.e. design, material intended use and function as the predicate iTotalCR KRS (K094050) as outlined in the table below: |
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ConforMIS iTotal CR Knee Repair System
<103 117*3|12/06/10
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Comparison of the Modified iTotal CR KRS with the Predicate iTotal CR KR System Characteristic Modified iTotal CR KRS Predicate iTotal CR KRS (K094050) (This submission) Indication for Use The iTotal® CR Knee Replacement System is Same 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 bi-compartmental prosthesis. The indications for use include: o Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. Post traumatic loss of joint function. o 0 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 implant is intended for cemented use only Yes Intended for Cement Yes Use Only Components Same Femoral Component o o Metal Backed Tibial Component o Patellar Component Same Materials Femoral Implant- CoCrMo o o Metal-Backed Tibial Components: Tibial tray- CoCrMo o Tibial Insert-UHMWPE o Patellar Component: UHMWPE o Knee joint patellofemorotibial semi -Design Same constrained cemented prosthesis Configuration Same -Femoral Implant Constant coronal curvature o � Same o Femoral cuts o o Distal femoral cuts Anterior femoral cut 0 の、 Anterior femoral chamfer cut Posterior femoral cuts 0 Posterior femoral chamfer cuts o
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K103117
ConforMIS iTotal CR Knee Repair System
Image /page/3/Picture/2 description: The image contains handwritten text. The text "K1031174914" is prominently displayed in a bold, cursive style. Above this, the date "12/06/10" is written in a smaller font.
| -Tibial Implant | Configuration: Metal Backed Tibial ImplantSingle or Dual insertsInsert sizes:6-16mmArticulating Surface:Curved Profile: patient specificTray interlock:Interference fit Anterior lip Tray undercut design | SameSameSameArticulating surface:Curved Profile: patient specificTray interlock:Interference fit No Anterior lip Tray pocket design |
|---|---|---|
| -Patellar Implant | Symmetrical, offered in sizes ranging from32, 35, 38 and 41 mm, with correspondingheights of 6, 7, 8.5 and 10 mm | Same |
| Principle of Operation | Cemented useFixed Bearing Design | Same |
| Posterior CruciateLigament (PCL) Sparing | Yes | Yes |
| Patient-Matched | Yes | Yes |
| Packaging | Device components are individually doublepouched using Tyvek® /film pouches which aresealed and labeled | Same |
| Safety andPerformance: | The determination of substantial equivalence for this device was basedon a detailed device description. Non-clinical laboratory testing wasperformed demonstrating that the device is safe and can be consideredsubstantially equivalent to the predicate device for the proposedintended use. Clinical data is not necessary to demonstrate substantialequivalence. |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConforMIS. Inc. % Ms. Amita S. Shah Director, Quality Assurance and Regulatory Affairs 2 Fourth Avenue Burlington, Massachusetts 01804
JAN - 7 2011
Re: K103117
Trade/Device Name: ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
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 Dated: December 6, 2010 Received: December 8, 2010
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
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Page 2 - Ms. Amita S. Shah
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 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/CDRHQffices/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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6.0 INDICATION FOR USE STATEMENT
510(k) Number (if known):
Device Name: ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
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, 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 bicompartmental implants.
The 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number 163117
§ 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.