(117 days)
Not Found
No
The description focuses on patient-specific design based on imaging and proprietary/off-the-shelf software, but does not mention AI or ML. The performance studies are based on material and mechanical testing, not algorithmic performance.
Yes
The device is a knee replacement system intended to treat painful joint disease and restore joint function, which are therapeutic purposes.
No
The iTotal® CR Knee Replacement System is an implantable prosthetic device for total knee replacement, not a device used to diagnose a medical condition. Its purpose is to treat painful joint disease and replace damaged knee components.
No
The device description clearly states that the system includes physical components such as a femoral component made of CoCrMo alloy, a tibial component with a metal tray and polyethylene inserts, and a patellar component made of UHMWPE. While software is used for design, the final product is a physical implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for a total knee replacement in patients with knee joint pain and disability. This is a surgical implant, not a test performed on samples taken from the body.
- Device Description: The device is described as a patient-specific tricompartmental knee replacement system consisting of femoral, tibial, and patellar components. These are physical implants.
- Function: The device replaces a damaged knee joint. IVDs are used to diagnose diseases or conditions by analyzing samples like blood, urine, or tissue.
- Performance Studies: The performance studies focus on material properties, biocompatibility, and wear testing of the implant components, not on the accuracy of a diagnostic test.
The device uses patient imaging (CT or MR scans) to design the implant, but this is for surgical planning and device customization, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
The implant is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OLY, OOG
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 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 that are manufactured from UHMWPE. The patellar component is also manufactured from UHMWPE.
ConforMIS is proposing a line extension of the current iTotal CR Knee Replacement System. The proposed line extension consists of providing tibial inserts and patellae made from a highly cross linked Vitamin E infused polyethylene (iPoly XE) similar to the predicate Biomet E-Poly™ Tibial Bearings (K080528) and the DJO Surgical Highly Cross-Linked Vitamin E UHMWPE Tibial Insert and Patella (K113756, K103223, K091956).
The iPoly XE tibial inserts and patellae will be manufactured from ultra high molecular weight polyethylene (UHMWPE) that is blended with Vitamin E (alpha-tocopherol), compression molded and then highly crosslinked. Other than the material, the iPoly XE Tibial inserts are identical in design to those cleared for the iTotal CR KRS via K120316. The iPoly XE patellae are also identical in design to those cleared via K112780.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR scans
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory testing was performed to determine substantial equivalence.
Testing included:
- Material properties of iPoly XE: Physical and Mechanical testing, Chemical Analysis
- Biocompatibility Testing of iPoly XE: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Material Mediated Pyrogenicity, Sub Chronic Toxicity, Genotoxicity, Muscle Implantation
- Performance testing of iPoly XE inserts and patellae: Wear testing per ISO 14243 (including under abrasive conditions), Contact area/contact stress testing, Tibial implant interlock testing, Patella subluxation testing, Analysis of wear debris
- Electromagnetic Compatibility: Evaluation of the Safety and Compatibility of the iTotal CR Knee Replacement System within the MRI Environment
Key results:
In-vitro knee simulator wear testing demonstrated that the iTotal CR KRS with iPoly XE exhibited a significant gravimetric wear reduction as compared to the iTotal CR KRS with conventional polyethylene tibial inserts. The results of in-vitro wear simulation testing have not been proven to quantitatively predict clinical wear performance.
All testing has demonstrated the device is substantially equivalent to the predicate devices.
Test results demonstrated that the device is safe and can be considered substantially equivalent to the predicate device for the intended use.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K120316, K112780, K120068, K113378, K103117, K094050, K080528, K113756, K103223, K091956
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(K) SUMMARY
JAN 1 4 2013
| Submitter's Name
and Address | ConforMIS Inc.
11 North Ave.
Burlington, MA 01803 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number | 3004153240 |
| Date of Summary | December 27, 2012 |
| Contact Person | Amita S. Shah, Vice President, Quality & Regulatory Affairs |
| Telephone Number | (781) 345-9164 |
| Fax Number | (781) 345-0104 |
| Name of the Device | ConforMIS iTotal® Cruciate Retaining Knee Replacement System with
iPoly XE™ Tibial Inserts and patellae |
| 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, Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis.
OIY, Prosthesis, knee, patellofemorotibial, semi-constrained, cemented
polymer + additive/metal/polymer + additive. This generic type of device
includes prosthesis that have a femoral component mode of alloys, such as
cobalt-chromium-molybdenum, and a tibial component(s) and/or a
retropatellar resurfacing component made of ultra-high molecular weight
polyethylene plus an additive, such as a-tocopherol.
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. |
Traditional 510(k) - iTotal® CR KRS- iPoly XE Inserts & Patellae
l. lfs
1
161228 20
| 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. The implant is intended for cemented use only | ||
| Identification of the | ||
| Legally Marketed | ||
| Devices | ||
| (Predicate Devices) | Device Class: | ConforMIS iTotal CR Knee Replacement System (KRS) |
| Product Code: | JWH, OOG | |
| Regulation Number: | 21 CFR 888.3560 | |
| 510(k) number: | K120316, K120068, K113378, K112780, K103117, | |
| K094050 | ||
| Device Class: | Biomet E-Poly™ Tibial Bearings | |
| Product Code: | JWH, MBH, MBV, OIY | |
| Regulation Number: | 21 CFR 888.3560 | |
| 510(k) number: | K080528 | |
| Device Class: | DJO Surgical Highly Cross-Linked Vitamin E UHMWPE Tibial Insert and Patella | |
| Product Code: | JWH, MBH, OIY |
Traditional 510(k) – iTotal® CR KRS- iPoly XE™ Inserts & Patellae
p, 2 of 8
2
Regulation Number: 21 CFR 888.3560 K113756. K103223. K091956 510(k) number:
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 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 that are manufactured from UHMWPE. The patellar component is also manufactured from UHMWPE.
ConforMIS is proposing a line extension of the current iTotal CR Knee Replacement System. The proposed line extension consists of providing tibial inserts and patellae made from a highly cross linked Vitamin E infused polyethylene (iPoly XE) similar to the predicate Biomet E-Poly™ Tibial Bearings (K080528) and the DJO Surgical Highly Cross-Linked Vitamin E UHMWPE Tibial Insert and Patella (K113756, K103223, K091956).
The iPoly XE tibial inserts and patellae will be manufactured from ultra high molecular weight polyethylene (UHMWPE) that is blended with Vitamin E (alpha-tocopherol), compression molded and then highly crosslinked. Other than the material, the iPoly XE Tibial inserts are identical in design to those cleared for the iTotal CR KRS via K120316. The iPoly XE patellae are also identical in design to those cleared via K112780.
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.
p. 3.fd
3
The function and general design features of the patient specific ancillary
instruments remain similar to those described in the predicate iTotal CR
510ks (K120316, K120068, K113378, K112780, K103117, K094050).
Substantial
Equivalence:
The product subject of this premarket notification is substantially equivalent
in design and functionality to the iTotal Cruciate Retaining Knee
Replacement System (K112780 cleared December 15, 2011 and K120316
cleared April 19, 2012). The iPoly XE tibial bearing material is similar to
the material used in the Biomet E-Poly Tibial bearings (K080528 cleared
June 17, 2008), and the DJO Surgical Highly Cross-Linked UHMWPE
Tibial Insert and Patella (K091956 cleared September 28, 2010, K103223
cleared December 21, 2010 and K113756 cleared March 14, 2012)
The following non-clinical laboratory testing was performed to determine
substantial equivalence:
- Material properties of iPoly XE
- Physical and Mechanical testing
- Chemical Analysis
- Biocompatibility Testing of iPoly XE
- Performance testing of iPoly XE inserts and patellae
- Wear testing
- Contact area/contact stress testing
- Tibial implant interlock testing
- Patella subluxation testing
In-vitro knee simulator wear testing provided in the submission
demonstrated that the iTotal CR KRS with iPoly XE exhibited a significant
gravimetric wear reduction as compared to the iTotal CR KRS with
conventional polyethylene tibial inserts. The results of in-vitro wear
All testing has demonstrated the device is substantially equivalent to the predicate devices.
simulation testing have not been proven to quantitatively predict clinical
wear performance.
4
| Total CR KRS with iPoly XE (This | Predicate iTotal CR KRS (K112780 and K120316) | Biomet E-Poly Tibial Bearings K080528 | Encore –DJO Surgical Highly Cross-linked Vitamin E UHMWPE Tibial Inserts and Patella K091956, K103223, K113756 | |
|---|---|---|---|---|
| Knee Replacement | ||||
| for use as a total knee | ||||
| replacements 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: | 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: | Indications for Use: |
- Painful and disabled knee joint resulting from
osteoarthritis, rheumatoid arthritis,
traumatic arthritis where one or more
compartments are involved. - Correction of varus, valgus, or posttraumatic
deformity.. - Correction or revision of unsuccessful
osteotomy, arthrodesis, or failure of
previous joint replacement procedure. | Joint replacement is indicated for patients suffering
from disability due to: | |
| 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. | 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. | For cemented and un-cemented use. | degenerative, post-traumatic or rheumatoid
arthritis; avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration,
particularly when there is patellofemoral
erosion dysfunction or prior patellectomy; moderate valgus, varus or flexion
deformities; Treatment of fractures that are
unmanageable using other techniques | |
| osteotomies,
hemiarthroplasties, and
unicondylar, patellofemoral or
compartmental implants. procedures provided
atomic landmarks
ary for alignment and
ing of the implant are
ble on patient imaging
only | The implant is intended for cemented use
only | | This device may also be indicated in the salvage of
previously failed surgical attempts. | |
| intended for cemented use | | | This device is intended to be used with the 3DKnee
System for cemented or uncemented applications. | |
| | | | Note: Patella component is only intended for
cemented use | |
| Characteristic | iTotal CR KRS with iPoly XE (This submission) | Predicate iTotal CR KRS (K112780 and K 120316) | Biomet E-Poly Tibial Bearings K080528 | Encore –DJO Surgical Highly Cross-linked Vitamin E UHMWPE Tibial Inserts and Patella K091956, K103223, K113756 |
| Intended for Cement Use Only | Yes | Yes | No | No |
| Product classification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 | 21 CFR 888.3560 |
| Materials | Metal-Backed Tibial Components:
Tibial tray- CoCrMo Tibial Insert-Vitamin E infused highly cross-linked UHMWPE Patellar Component: Vitamin E infused highly cross-linked UHMWPE | Metal-Backed Tibial Components:
Tibial tray- CoCrMo Tibial Insert-UHMWPE Patellar Component: UHMWPE | Metal-Backed Tibial Components:
Tibial tray- CoCrMo Tibial Insert-Vitamin E infused highly cross-linked UHMWPE Patellar component- UHMWPE | Metal-Backed Tibial Components:
Tibial tray- CoCrMo Tibial Insert-Vitamin E infused highly cross-linked UHMWPE Patellar component - Vitamin E infused highly cross-linked UHMWPE |
| Design | Knee joint patellofemorotibial semi – constrained cemented prosthesis | Knee joint patellofemorotibial semi -constrained cemented prosthesis | Knee joint patellofemorotibial semi-constrained cemented prosthesis | Knee joint patellofemorotibial polymer/metal!/polymer semi-constrained cemented prosthesis |
| Tibial Implant | Configuration: Metal Backed Tibial Implant
Tibial Insert-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
Single or Dual inserts Insert sizes:6-16mm Profile: patient specific | Configuration: Metal Backed Tibial Implant
Tibial Insert-Vitamin E infused highly cross-linked UHMWPE
Single inserts Five insert sizes – five thickness/size | Configuration: Metal Backed Tibial Implant
Tibial Insert-Vitamin E infused highly cross- linked UHMWPE
Single inserts 9 insert sizes (2-12) and 5 thicknesses (9-19) |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs | Non Patient-specific jigs | Unknown |
| Principle of Operation | Cemented use
Fixed Bearing Design | Cemented use
Fixed Bearing Design | Cemented or un-cemented use
Fixed Bearing Design | Cemented or un-cemented use
Fixed Bearing Design |
| Posterior Cruciate Ligament (PCL) Sparing | Yes | Yes | Yes | Yes |
| Patient-Matched | Yes | Yes | No | No |
| Characteristic | iTotal CR KRS with iPoly XE (This submission) | Predicate iTotal CR KRS (K112780 and K120316) | Biomet E-Poly Tibial Bearings K080528 | Encore -DJO Surgical Highly Cross-linked Vitamin E UHMWPE Tibial Inserts and Patella K091956, K103223, K113756 |
| 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 | Unknown | Unknown |
| Sterility Method/Assurance Level | VHP Gas Plasma 1x10-6 | VHP Gas Plasma 1x10-6 | Unknown | VHP Gas Plasma |
| Initial Shelf-Life | 6 months | 6 months | Unknown | Unknown |
| Labeled Non-pyrogenic | No | No | No | No |
raditional 510(k) – iTotal® CR KRS– iPoly XE Inserts & Patellae
( -- -- -- -- -- -- --
$\langle 12.2\rangle 70
5
Traditional 510(k) – iTotal® CR KRS- iPoly XE™ Inserts & Patellae
p. 66f8
6
Traditional 510(k) – iTotal® CR KRS-- iPoly XE™ Inserts & Patellae
K12-2870
7
| Description and | The determination of substantial equivalence for this device was based |
|---|---|
| Conclusion of | on a detailed device description and non-clinical laboratory testing. |
| Testing | Testing on the iPoly XE outlined below: |
| Property /Characteristic | Tests conducted |
|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic |
| Toxicity, Material Mediated Pyrogenicity, Sub Chronic Toxicity, | |
| Genotoxicity, Muscle Implantation | |
| Physical and Mechanical Properties | Small Punch Test, Fatigue Crack Growth Test, Izod Impact Test, |
| Static Tensile Test, Compressive Modulus Test | |
| Chemical Properties | Scanning Electron Microscopy analysis, Differential Scanning |
| Calorimetry analysis, Free Radical Content, Oxidization Index, | |
| Extraction analysis, Residue on extraction, Uniformity of radiation | |
| dose, Cross-link Density, Vitamin E Content, Ash Content | |
| Environmental Stress Cracking, | |
| Performance Testing | Tibiofemoral Contact Area/Stress, Strength of Tibial interlock, |
| Patella Shear Test, Patella Tensile Test, Patellofemoral Contact | |
| Area/Stress Test, Wear Testing per ISO 14243. Wear Testing | |
| under abrasive conditions, Analysis of wear debris. | |
| Electromagnetic Compatibility | Evaluation of the Safety and Compatibility of the iTotal CR Knee |
| Replacement System within the MRI Environment | |
| 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 iPoly XE tibial inserts and patellae is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System K112780 cleared December 15, 2011, K120316 cleared April 19, 2012, K080528 (Biomet) cleared June 17, 2008, K091956 (DJO Surgical) cleared September 28, 2010, K103223 (DJO Surgical) cleared December 21, 2010, and K113756 (DJO Surgical) cleared March 14, 2012.
8
Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Letter dated: January 14, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Conformis, Incorporated % Ms. Amita Shah Vice President, Ouality & Regulatory Affairs 11 North Avenue Burlington, Massachusetts 01803
Re: K122870
. 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 semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH, OOG Dated: December 6, 2012
Received: December 7, 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. 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
9
Page 2 - Ms. Amita Shah
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/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/ReportalProblem/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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): K122870
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, 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 implant is intended for cemented use only.
Over-The-Counter Use Prescription Use __ X AND/OR (Part 21 CFR 801 Subpart D) (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) 01.14 13:28:56 Anton E. Dmitriev, PhD Division of Orthopedic Devices
Traditional 510(k) - iTotal® CR KRS- iPoly XE™ Inserts & Patellae