(86 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the mechanical components and intended use with a robotic system, not AI/ML capabilities.
Yes
The device is a knee replacement system intended to treat osteoarthritis and posttraumatic arthritis, which are medical conditions, thus making it a therapeutic device.
No
The device, RESTORIS MCK, is described as a knee replacement implant system for surgical use in individuals with osteoarthritis or posttraumatic arthritis. Its purpose is to replace damaged joint surfaces, not to diagnose medical conditions.
No
The device description explicitly states that the Restoris MCK is composed of implant systems (Restoris MCK Uni and Restoris MCK PF), which are physical components intended for implantation. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the RESTORIS MCK is a knee replacement system used in surgery for individuals with osteoarthritis or posttraumatic arthritis. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the components of the implant system (femoral and tibial components, patellofemoral components) which are designed to be surgically implanted into the knee joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
Therefore, the RESTORIS MCK is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RESTORIS MCK is indicated for single or multi-compartment 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 MCK is for single use only and is intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
KRR, HSX, NPJ, HRY
Device Description
The Restoris MCK is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). Restoris MCK Uni and Restoris MCK PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial or lateral side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Implant Components: Restoris MCK Uni - Femoral Condyle component, Tibial Inlay component, Radiographic marker in Tibial Inlay component, Tibial Onlay Insert component, Tibial Baseplate. Restoris MCK PF - Patellofemoral component, Patella component.
Sizes: Restoris MCK Uni - Femoral Condyle components are available in 8 sizes. Tibial components are available in 8 sizes. Restoris MCK PF - Patellofemoral components available in 8 sizes. Patella components are available in 6 sizes.
Materials: Restoris MCK Uni - Femoral Condyle component – CoCrMo alloy, Tibia Inlay component – UHMWPE, Radiographic marker in Tibial Inlay component – Unalloyed titanium wire, Tibia Onlay Insert component – UHMWPE, Tibial Baseplate – Ti6Al4V ELI alloy. Restoris MCK PF - Patellofemoral component – CoCrMo alloy, Patella component – UHMWPE.
Instrumentation: Provided separately in a re-usable/sterilizable tray. Tray includes various tools (e.g., sizers, templates, trials, drills, gauges, impactors, inserters, extractors) used during surgery. Restoris MCK can only be used with the MAKO Robotic Arm Interactive Orthopedic System (RIO).
Sterilization and Packaging: Sterilization: All components – gamma radiation, Instrumentation – steam sterilization. Packaging: All components are supplied in double sealed containers maintaining double sterile barriers.
Biocompatibility: All components are made of materials for surgical implant applications per recognized ASTM standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, tibiofemoral and/or patellofemoral articular surfaces.
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)
Not Found
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/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP" in smaller letters underneath. Above the word "MAKO" is a stylized graphic that resembles a mountain range. The text "KD9" is written in the upper right corner of the image.
JUN 1 7 2009
2555 Davie Road . Et. Lauderdale, El, 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) 954-927-2044 x 605; (F) 954-927-0446 |
| Contact Person: | William F. Tapia |
| Date Prepared: | March 18, 2009 |
| Proprietary Name: | Restoris MultiCompartmental Knee System (Restoris MCK) |
| Common Name: | Compartmental Knee Prosthesis System |
| Classification: | Class II |
| Product Code / #: | KRR - Knee joint patellofemoral polymer/metal semi-constrained cemented |
| prosthesis; 21 CFR 888.3540 | |
| HSX - Knee joint femorotibial metal/polymer non-constrained cemented | |
| prosthesis; 21 CFR 888.3520 | |
| NPJ - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained | |
| cemented prosthesis; 21 CFR 888.3560 | |
| HRY - Knee joint femorotibial metal/polymer semi-constrained cemented | |
| prosthesis; 21 CFR 888.3530 |
Description: The Restoris MCK is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). Restoris MCK Uni and Restoris MCK PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial or lateral side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
| Feature | Restoris MCK |
|---|---|
| Implant Components | Restoris MCK Uni Femoral Condyle component Tibial Inlay component Radiographic marker in Tibial Inlay component Tibial Onlay Insert component Tibial Baseplate |
| Restoris MCK PF Patellofemoral component Patella component | |
| Sizes | Restoris MCK Uni Femoral Condyle components are available in 8 sizes. Tibial components are available in 8 sizes. Restoris MCK PF Patellofemoral components available in 8 sizes. Patella components are available in 6 sizes. |
| Materials | Restoris MCK Uni Femoral Condyle component – CoCrMo alloy Tibia Inlay component – UHMWPE Radiographic marker in Tibial Inlay component – Unalloyed titanium wire Tibia Onlay Insert component – UHMWPE Tibial Baseplate – Ti6Al4V ELI alloy Restoris MCK PF Patellofemoral component – CoCrMo alloy Patella component – UHMWPE |
| Instrumentation | Provided separately in a re-usable/sterilizable tray. Tray includes various tools |
| (e.g., sizers, templates, trials, drills, gauges, impactors, inserters, extractors) used | |
| during surgery. Restoris MCK can only be used with the MAKO Robotic Arm | |
| Interactive Orthopedic System (RIO) |
1
Image /page/1/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the word "MAKO" is a stylized image of a mountain range. The mountain range is shaded with a gradient, with the top of the mountains being lighter than the bottom.
2555 Davie Road_ * . Et. Lauderdale, FL 33317 . • Phone 954.927.0446 . • Fax 954.927.0446 . • www.makosurgical.com...
| Sterilization and Packaging | Sterilization:
o All components – gamma radiation
o Instrumentation – steam sterilization
Packaging:
o All components are supplied in double sealed containers maintaining double
sterile barriers. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | All components are made of materials for surgical implant applications per
recognized ASTM standards. |
Substantial Equivalence: Restoris MCK is substantially equivalent to the MAKO Modular Knee System (K082172).
Indications for Use:
RESTORIS MCK is indicated for single or multi-compartment 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 MCK is for single use only and is intended for implantation with bone cement.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2009
MAKO Surgical Corporation % Mr. William F. Tapia 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K090763
Trade/Device Name: Restoris MultiCompartmental Knee System (Restoris MCK) Regulation Number: 21 CFR 888.3560
Regulation Name: Knee ioint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis
Regulatory Class: Class II Product Code: NPJ, KRR, HSX, HRY Dated: March 17, 2009 Received: March 23, 2009
Dear Mr. Tapia:
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.
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 farther 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
3
Page 2-Mr. William F. Tapia
(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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehr
Mark N. Mellman
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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Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP" in smaller letters underneath. Above the word "MAKO" is a stylized graphic that resembles a shark fin or a mountain peak. The logo is simple and modern, and it conveys a sense of strength and precision.
2555 Davie Road
INDICATIONS FOR USE
510(k) Number (if known): K090763
Device Name: Restoris MultiCompartmental Knee System (Restoris MCK)
Indications for Use:
RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic 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 MCK 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.C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oputa
(Division Sign-Off)
(Division Sign-6 (Division Sign-Ord), Orthopedic, Divisionative Devices
510(k) Number K090763