(75 days)
Not Found
No
The summary describes a knee implant system and its use with a robotic arm system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on the mechanical components and their performance.
Yes
The device is indicated for knee replacement in individuals with osteoarthritis or post-traumatic arthritis, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is an implant system (knee replacement) used in orthopedic surgery, not a tool for diagnosing medical conditions.
No
The device description explicitly details physical implant components (femoral condyle components, tibial onlay components, patellofemoral trochlear components, patella components) which are hardware. The summary also describes performance testing related to these physical components (e.g., Insert Snaplock Strength, Tibial Insert Wear).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed for surgical implantation into the knee joint. It is a physical device used to replace damaged parts of the knee.
- Intended Use: The intended use is for single or multicompartmental knee replacement in individuals with osteoarthritis or post-traumatic arthritis. This is a surgical procedure, not a diagnostic test performed on a sample.
The provided information clearly describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- Medial unicondylar
- · Lateral unicondylar
- · Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HSX, HRY, KRR, NPJ, OIY
Device Description
RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).
- RESTORIS™ MCK Uni: .
- Unicompartmental femoral condyle components o
- Unicompartmental tibial onlay components (tibial baseplate and tibial onlay o insert)
- Unicompartmental tibial inlay components 0
- RESTORIS™ MCK PF: .
- Patellofemoral trochlear components o
- Patella components o
The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multi-compartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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 RESTORIS™ Multicompartmental Knee System has been evaluated through non-clinical performance testing for:
- Insert Snaplock Strength .
- Tibial Insert / Baseplate Micromotion ●
- Tibio-Femoral Range of Motion .
- Tibio-Femoral Instability ●
- Tibio-Femoral Contact Area and Stress .
- Tibial Insert Fatigue .
- . Tibial Insert Wear
- Packaging Validation .
- EtO Sterilization Validation .
- 5 Year Aging ●
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): 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.
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
Image /page/0/Picture/1 description: The image shows the logo for MAKO SURGICAL CORP. The logo features the word "MAKO" in a bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font underneath. Above the word "MAKO" is a stylized graphic that resembles a shark fin. The logo is black and white.
DEC 1 0 2013
2555 Davle Road. • Et. Lauderdale, EL 33317. • Phone 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: | September 20, 2013 | |
| Proprietary Name: | ||
| System | The RESTORIS™ Multicompartmental (MCK) Knee System | |
| Common Name: | Partial Knee System | |
| Classification: | Class II |
Product Codes/Classification #:
| Code of Federal
Regulations | Product
code | Description |
|--------------------------------|-----------------|-----------------------------------------------------------------------------------------------|
| 21 CFR 888.3520 | HSX | Knee joint femorotibial metal/polymer non constrained
cemented prosthesis |
| 21 CFR 888.3530 | HRY | Knee joint femorotibial metal/polymer semi constrained
cemented prosthesis |
| 21 CFR 888.3540 | KRR | Knee joint patellofemoral polymer/metal semi
constrained cemented prosthesis |
| 21 CFR 888.3560 | NPJ | Knee joint patellofemorotibial polymer/metal/polymer
semi constrained cemented prosthesis |
| 21 CFR 888.3560 | OIY | Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis. |
Reason for 510(k) submission: Device modification
Device Modification:
- Addition of Highly Cross-linked Vitamin E UHMWPE onlay tibial insert .
- EtO Sterilization ●
- Packaging .
1
K133039 (2/3)
Image /page/1/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, sans-serif font, with a stylized shark fin shape above it. Below "MAKO" is the text "SURGICAL CORP" in a smaller, sans-serif font. The logo is black and white.
2555 Davie Road • Et. Lauderdale, FL 33317 • Phone 954,927,2044 • Fax 954,927,0446 • www.makosurgical.com_
Device Description:
RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).
- RESTORIS™ MCK Uni: .
- Unicompartmental femoral condyle components o
- Unicompartmental tibial onlay components (tibial baseplate and tibial onlay o insert)
- Unicompartmental tibial inlay components 0
- RESTORIS™ MCK PF: .
- Patellofemoral trochlear components o
- Patella components o
The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multi-compartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.
Intended Use:
Restoris™ Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- Medial unicondylar
- Lateral unicondylar
- · Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)
The RESTORIS™ Multicompartmental Knee System is for single use only and is intended for implantation with bone cement.
2
Image /page/2/Picture/1 description: The image shows the logo for MAKO SURGICAL CORP. The logo features the word "MAKO" in large, bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic element that resembles a shark fin or a stylized letter "A". The logo is black and white.
2555 Davie Road . . Et. Lauderdale, FL 33317 . • Phone 954.927.0446 . www.makosurgical.com
Substantial Equivalence:
The RESTORIS™ Multicompartmental Knee System is substantially equivalent to the following 510(k) cleared devices.
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| RESTORIS Multicompartmental Knee System | MAKO | K090763 |
Technological Characteristics:
The RESTORISTM Multicompartmental 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 design/technological characteristics and have performance characteristics adequate to withstand anticipated physiological loading.
Performance Data:
The RESTORIS™ Multicompartmental Knee System has been evaluated through non-clinical performance testing for:
- Insert Snaplock Strength .
- Tibial Insert / Baseplate Micromotion ●
- Tibio-Femoral Range of Motion .
- Tibio-Femoral Instability ●
- Tibio-Femoral Contact Area and Stress .
- Tibial Insert Fatigue .
- . Tibial Insert Wear
- Packaging Validation .
- EtO Sterilization Validation .
- 5 Year Aging ●
Conclusions of 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.
Summary of Design Control Activities:
The risk analysis activities for this device modification include a risk management plan, hazard analysis and Failure Modes and Effects Analysis (FMEAs). Based upon the review of this data and information obtained through verification and validation activities, there are no unacceptable levels of risks that have been identified resulting from the device modification.
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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes on its wing, representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 10, 2013
MAKO Surgical Corporation Mr. Jonathan Reeves Principal Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K133039
Trade/Device Name: RESTORIS™ Multicompartmental Knee (MCK) System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: NPJ, KRR, HSX, HRY, OIY Dated: November 13, 2013 Received: November 14, 2013
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 (2 1 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
4
Page 2 - Mr. Jonathan Reeves
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 cntitled, "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
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -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/5/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic that resembles a shark fin or a mountain peak. The logo is black and white.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K133039
Device Name: RESTORIS™ Multicompartmental Knee (MCK) System
Indications for Use:
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- Medial unicondylar
- · Lateral unicondylar
- · Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
Prescription Use (Part 21 CFR 801 Subpart D) .
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
C)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Casey L. Hanley; Ph.D.
Division of Orthopedic Devices
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