(310 days)
Not Found
No
The summary describes a patient-specific knee replacement system based on radiological information, but there is no mention of AI or ML being used in the design, manufacturing, or application of the device. The focus is on the materials, components, and intended use.
Yes
The device is a total knee replacement, which is explicitly used to replace diseased or deficient bone around the knee joint to alleviate pain and disability. This aligns with the definition of a therapeutic device as it treats a medical condition.
No
The device is a total knee replacement system, intended for replacing diseased or deficient bone. Its function is to treat conditions rather than diagnose them.
No
The device description explicitly details physical components made of titanium, cobalt-chromium-molybdenum, and UHMWPE, which are hardware materials. The device is a total knee replacement system, which is a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Patient Specific SMILES Total Knee Replacement is a surgical implant intended to replace diseased or deficient bone in the knee joint. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic information derived from such tests.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Patient Specific SMILES Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. It is indicated for:
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
- Correction of varus, valgus or post traumatic deformity
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
- Ligament deficiencies
- Tumor resection
- Revision of previously failed total joint arthroplasty
- Trauma
- The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue
The Patient Specific SMILES Total Knee Replacement and its components are for cemented use only.
The Patient Specific Patient Specific SMILES Total Knee Replacement and its components are for single use only.
Product codes
KRO
Device Description
The Patient Specific SMILES Total Knee Replacement is a patient-specific system that is intended for the replacement of diseased or deficient bone around the knee joint. The system includes three tibial options: 1) metal cased rotating hinge, 2) fixed hinge, and 3) rotating hinge polyethylene tibia. The Patient Specific SMILES Total Knee Replacement and its components are intended for cemented use only.
The materials used in the manufacture of the Patient Specific SMILES Total Knee Replacement include titanium (Ti), cobalt-chromium-molybdenum (Co-Cr-Mo) and ultra-high molecular weight polyethylene (UHMWPE).
The device is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
The Patient Specific SMILES Total Knee Replacement is based on the surgeon's prescription and the patient radiological information.
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)
The Patient Specific SMILES Total Knee Replacement has been evaluated through non-clinical performance testing for fatigue and wearing testing of the knee and ASTM F1800-07 testing. The Patient Specific SMILES Total Knee Replacement met all of the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
August 12, 2021
Stanmore Worldwide Implants Ltd. Dan Clarke Regulatory and Compliance Officer 210 Centennial Avenue Centennial Park Elstree, WD6 3SJ United Kingdom
Re: K140900
Trade/Device Name: Patient Specific Smiles Total Knee Replacement Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO
Dear Dan Clarke:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 12, 2015. Specifically, FDA is updating this SE Letter to correct a typo in the company name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ting Song, Ph.D., OHT6: Office of Orthopedic Devices, 301-796-7677, Ting.Song@fda.hhs.gov.
Sincerely,
Image /page/0/Picture/9 description: The image shows the name "Ting Song -S" in a large, sans-serif font. The text is black and stands out against a white background. The letters are evenly spaced and the text is horizontally aligned. The image is simple and clear, with a focus on the text.
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
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or fabric. The profiles are stacked slightly offset from each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2015
Stanmore, Incorporated Mr. Dan Clarke Director of Regulatory Affairs 210 Centennial Avenue, Centennial Park Elstree WD6 3SJ United Kingdom
Re: K140900
Trade/Device Name: Patient Specific SMILES Total Knee Replacement Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: January 14, 2015 Received: January 16, 2015
Dear Mr. Clarke:
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
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(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 (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
- To be assigned 510(k) Number:
Device Name: Patient Specific SMILES Total Knee Replacement
Indications for Use: The Patient Specific SMILES Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. It is indicated for:
- Painful and disabled joint resulting from avascular necrosis, 0 osteoarthritis, rheumatoid arthritis or traumatic arthritis
- Correction of varus, valgus or post traumatic deformity .
- . Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
- Ligament deficiencies .
- Tumor resection .
- Revision of previously failed total joint arthroplasty .
- . Trauma
- . The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue
The Patient Specific SMILES Total Knee Replacement and its components are for cemented use only.
The Patient Specific Patient Specific SMILES Total Knee Replacement and its components are for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
| Device Proprietary Name: | Patient Specific SMILES Total Knee Replacement |
|---|---|
| Common Name: | Prosthesis, Knee, Femorotibial, Constrained, Cemented, |
| Metal/Polymer | |
| Classification Regulation: | 21 CFR 888.3510 |
| Submitter's Name: | |
| Address: | Stanmore Worldwide Implants Ltd. |
| 210 Centennial Avenue | |
| Centennial Park | |
| Elstree | |
| WD6 3SJ UNITED KINGDOM | |
| Contact Person: | Jon Charters |
| Telephone Number: | +44-20-8238-6500 |
| Fax Number: | +44-20-8953-7443 |
| Date Summary Prepared: | March 31, 2014 |
Device Description
The Patient Specific SMILES Total Knee Replacement is a patient-specific system that is intended for the replacement of diseased or deficient bone around the knee joint. The system includes three tibial options: 1) metal cased rotating hinge, 2) fixed hinge, and 3) rotating hinge polyethylene tibia. The Patient Specific SMILES Total Knee Replacement and its components are intended for cemented use only.
The materials used in the manufacture of the Patient Specific SMILES Total Knee Replacement include titanium (Ti), cobalt-chromium-molybdenum (Co-Cr-Mo) and ultra-high molecular weight polyethylene (UHMWPE).
The device is for single use only.
Purpose of Submission
This Premarket Notification is being submitted as a modification to the METS® SMILES Total Knee Replacement to add patient-specific components and an extra-small option for the knee.
Intended Use
The Patient Specific SMILES Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. It is indicated for:
- . Painful and disabled joint resulting from avascular necrosis. osteoarthritis, rheumatoid arthritis or traumatic arthritis
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- . Correction of varus, valgus or post traumatic deformity
- . Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
- Ligament deficiencies .
- . Tumor resection
- Revision of previously failed total joint arthroplasty .
- . Trauma
- The fixed hinge tibial component is intended for limb salvage . procedures requiring radical resection of bone and soft tissue
The Patient Specific SMILES Total Knee Replacement and its components are for single use only. The Patient Specific SMILES Total Knee Replacement and its components are for cemented use only.
Predicate Device(s)
The predicate devices are the METS® SMILES Total Knee Replacement cleared on September 5, 2012 (K120992), the JTS® Extendible Distal Femoral Implant cleared on March 22, 2011(K092138) and the JTS® Extendible Distal Femoral Implant cleared on January 22, 2014 (K133152).
Technological Characteristics
The Patient Specific SMILES Total Knee Replacement is a patient-specific implant system that is used to replace diseased or deficient bone around the knee joint.
The Patient Specific SMILES Total Knee Replacement is based on the surgeon's prescription and the patient radiological information. The implant is designed and manufactured for each patient.
The Patient Specific SMILES Total Knee Replacement is provided sterile by gamma irradiation.
Substantial Equivalence
The Patient Specific SMILES Total Knee Replacement has the same intended use and technological characteristics as the METS® SMILE Total Knee Replacement (K120992). The difference between the two implant systems is that the current version includes patient-specific components and an extra-small option for the knee. These new components have been cleared previously by FDA as part of the JTS® Extendible Distal Femoral Implant (K092138 and K133152).
Performance Data
The Patient Specific SMILES Total Knee Replacement has been evaluated through non-clinical performance testing for fatigue and wearing testing of the knee and ASTM F1800-07 testing. The Patient Specific SMILES Total Knee Replacement met all of the acceptance criteria.
The Patient Specific SMILES Total Knee Replacement does not alter the fundamental scientific technology of the METS® SMILES Total Knee Replacement, alter the indication for use or raise
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any new questions of safety or effectiveness. Therefore, the Patient Specific SMILES Total Knee Replacement is substantially equivalent to its predicate device.