(60 days)
No
The summary describes a traditional knee implant system and its components, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is a prosthesis designed to replace a diseased or damaged knee joint, which falls under the definition of a therapeutic device as it treats a medical condition.
No
The KINETIS™ Total Knee System is a surgical implant (knee joint prosthesis) used for total knee replacement, not a device used to diagnose medical conditions. Its indications for use describe conditions that would lead to surgery, not conditions it would diagnose.
No
The device description explicitly states it includes physical components such as femoral component, tibial tray, tibial inserts, patella component, and associated instruments, which are made of polymer and metal.
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: The KINETIS™ Total Knee System is a prosthetic implant designed to replace a damaged knee joint. It is a physical device implanted into the body.
- Intended Use: The intended use is for total knee replacement surgery in patients with severe knee pain and disability due to various conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
Therefore, the KINETIS™ Total Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KINETIS™ Total Knee System components are indicated for use in skeletally mature patients, with severe knee pain and disability, undergoing primary surgery for total knee replacement due to:
- Rheumatoid arthritis, osteoarthritic, traumatic arthritis, polyarthritis. ●
- Collagen disorders, and/or avascular necrosis of the femoral condyle ●
- o Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis
- Moderate valgus, varus, or flexion deformities. o
MAKO KINETIS™ Total Knee Replacement System components are indicated for use only with cement and are single use devices
Product codes
JWH, OIY
Device Description
The Kinetis™ Total Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained cemented knee joint prosthesis. The system includes femoral component, tibial tray, biomimetic tibial inserts, patella component, and associated instruments. The biomimetic tibial inserts are manufactured from highly cross-linked vitamin E polyethylene. The system is for use in cases where the anterior and posterior cruciate ligaments are retained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Skeletally mature patients
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 Kinetis™ Total Knee System has been evaluated through non-clinical performance testing for;
- Tibial Baseplate Fatigue ●
- Tibial Baseplate Fixation ●
- Insert Locking Mechanism Strength ●
- Tibial Insert / Baseplate Micromotion
- Tibio-Femoral Range of Motion
- Tibio-Femoral Range of Constraint
- . Tibio-Femoral Contact Area and Stress
- Tibial Insert Fatigue
- Patello Femoral Subluxation
- Patello-Femoral Lateral Jump Height
- Patello-Femoral Contact Area and Stress ●
- Femoral Fatigue ●
- Wear .
- Tibial Eminence Strength .
The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2015
MAKO Surgical Corporation Mr. Jonathan Reeves Senior Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K143635
Trade/Device Name: The KINETIS™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: December 19, 2014 Received: December 24, 2014
Dear Mr. Reeves:
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
1
Page 2 – Mr. Jonathan Reeves
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 yours,
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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Image /page/2/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Below "MAKO" is the text "SURGICAL CORP." in smaller, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or an abstract mountain range.
555 Davie Road • Ft. Lauderdale, FL 27.2044 • Fax 954.927.0 ww.makosurgical.com
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K143635
Device Name: The KINETIS™ Total Knee System
Indications for Use:
The KINETIS™ Total Knee System components are indicated for use in skeletally mature patients, with severe knee pain and disability, undergoing primary surgery for total knee replacement due to:
- Rheumatoid arthritis, osteoarthritic, traumatic arthritis, polyarthritis. ●
- Collagen disorders, and/or avascular necrosis of the femoral condyle ●
- o Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis
- Moderate valgus, varus, or flexion deformities. o
MAKO KINETIS™ Total Knee Replacement System components are indicated for use only with cement and are single use devices
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart
C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Below "MAKO" is the text "SURGICAL CORP." in smaller, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or an abstract mountain range.
2555 Davie Road • Ft. Lauderdale, FL 33317 Phone 954.927.2044 • Fax 954.927.0446 www.makosurgical.com
510(K) SUMMARY
| Submitter: | MAKO Surgical Corp. |
|---|---|
| Address: | 2555 Davie Road, Fort Lauderdale, FL 33317 |
| Phone number/ Fax Number: | (Ph) 954-628-0665; (F) 954-927-0446 |
| Contact Person: | Jonathan Reeves |
| Date Prepared: | December 19, 2014 |
| Proprietary Name: | The Kinetis™ Total Knee System |
| Common Name: | Total Knee System |
| Classification: | Class II |
| Product Codes/Classification#: | JWH - Knee joint patellofemorotibial |
| polymer/metal/polymer semi-constrained cemented | |
| prosthesis (888.3560) |
OIY - Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis (888.3560) |
| Reason for 510(k) submission: | New device submission |
Device Description:
The Kinetis™ Total Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained cemented knee joint prosthesis. The system includes femoral component, tibial tray, biomimetic tibial inserts, patella component, and associated instruments. The biomimetic tibial inserts are manufactured from highly cross-linked vitamin E polyethylene. The system is for use in cases where the anterior and posterior cruciate ligaments are retained.
Intended Use:
The Kinetis™ Total Knee System components are indicated for use in skeletally mature patients, with severe knee pain and disability, undergoing primary surgery for total knee replacement due to:
4
- Rheumatoid arthritis, osteoarthritic, traumatic arthritis, polyarthritis. ●
- Collagen disorders, and/or avascular necrosis of the femoral condyle
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic ● arthritis, or avascular necrosis
- Moderate valgus, varus, or flexion deformities.
MAKO Kinetis" Total Knee System components are indicated for use only with cement and are single use devices.
Primary Predicate Device:
MAKO Kinetis "10 Total Knee System is substantially equivalent to the following 510(k) cleared device:
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| Vanguard XP Knee System | Biomet | K122160 |
Additional Predicate Devices:
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| Townley Total Knee | BioPro | K904448 |
| Axiom Knee | Orthomet | K926334 |
References Devices:
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| Total Knee System | Pipeline | K123692 |
Technological Characteristics:
The Kinetis™ Total Knee System is similar to legally marketed devices listed previously in that they share the same indications for use, are manufactured from the same or similar material, have same or similar design/technological characteristics, and have performance characteristics adequate to withstand anticipated physiological loading.
Performance Data:
The Kinetis™ Total Knee System has been evaluated through non-clinical performance testing for;
- Tibial Baseplate Fatigue ●
- Tibial Baseplate Fixation ●
- Insert Locking Mechanism Strength ●
- Tibial Insert / Baseplate Micromotion
- Tibio-Femoral Range of Motion
- Tibio-Femoral Range of Constraint
- . Tibio-Femoral Contact Area and Stress
- Tibial Insert Fatigue
- Patello Femoral Subluxation
- Patello-Femoral Lateral Jump Height
- Patello-Femoral Contact Area and Stress ●
- Femoral Fatigue ●
- Wear .
5
- Tibial Eminence Strength .
Conclusions from Clinical and Non-clinical Data:
The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices.
Image /page/5/Picture/3 description: The image shows a light blue abstract shape against a white background. The shape is curved and tapers at both ends, resembling a stylized wing or a swooping arc. The color is a soft, pastel blue, and the overall impression is minimalist and clean.