(30 days)
No
The document describes a mechanical knee implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a knee prosthesis intended to treat painful osteo- or post-traumatic arthritis and revise unsuccessful surgical procedures to alleviate pain and restore joint function. These actions are rehabilitative and directly address a disease state, aligning with the definition of a therapeutic device.
No
The provided information describes the Restoris® Porous Partial Knee System as a knee arthroplasty device, an implant intended for surgical treatment of joint disease and arthritis. It is a therapy device, not a diagnostic one.
No
The device description clearly states that the device consists of physical components (femoral components and tibial baseplate components) made of materials like CoCr and Ti6Al4V, intended for surgical implantation. This 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 describes a surgical implant for treating knee joint conditions like osteoarthritis and post-traumatic arthritis. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a knee prosthesis (femoral components and tibial baseplate) designed for surgical implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) to diagnose a condition.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the implant (strength, micromotion, range of motion, wear), which are relevant to a surgical device, not an IVD.
IVD devices are used to perform tests in vitro (outside the body) on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is implanted in vivo (inside the body) to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:
· Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
The Restoris® Porous Femoral Component and PST® Tibial Baseplate are intended for cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.
Product codes (comma separated list FDA assigned to the subject device)
HRY, NJD, OIY
Device Description
The RESTORIS® Porous Partial Knee System is a knee joint femorotibial (unicompartmental) prosthesis. The RESTORIS® Porous Partial Knee System consists of femoral components and tibial baseplate components that are compatible with and intended for use with MAKO's predicate RESTORIS MCK Tibial Onlay Insert Components (K090763 or K133039).
The RESTORIS® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.
The Porous Femur components: sizes 1 through 8, CoCr with a CoCr porous coating for cementless fixation, asymmetric design (meaning that left medial implants can be used on the right lateral compartment and right medial implants can be used on the left lateral compartment; abbreviated hereafter as LM/RL and RM/LL)
PST® Tibial Baseplate components: sizes 1 through 8. Ti6Al4V allov with MAKO's predicate porous surface (porous structured technology, referred to as "PST®"), asymmetric (LM/RL-RM/LL).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (unicompartmental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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® Porous Partial 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
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.
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.
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
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
MAKO Surgical Corporation Mr. Jonathan Reeves Principal Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317
Re: K150410
Trade/Device Name: RESTORIS® Porous Partial Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY, NJD, OIY Dated: February 16, 2015 Received: February 18, 2015
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/Resourcesfor You/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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Indications for Use
510(k) Number (if known) K150410
Device Name RESTORIS® Porous Partial Knee System
Indications for Use (Describe)
The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:
· Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
The Restoris® Porous Femoral Component and PST® Tibial Baseplate are intended for cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------- |
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3
Image /page/3/Picture/0 description: The image is a logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or a stylized fin. Below the word "MAKO" is the text "SURGICAL CORP" in smaller, black letters, with the registered trademark symbol next to it.
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: | February 13, 2015 | |
| Proprietary Name: | RESTORIS® Porous Partial Knee System | |
| Common Name: | Partial Knee System | |
| Classification: | Class II |
Product Codes/Classification #:
| Code of Federal
Regulations | Product
code | Description |
|--------------------------------|-----------------|--------------------------------------------------------------------------------------------------|
| 21 CFR 888.3530 | HRY | Knee joint femorotibial metal/polymer semi constrained
cemented prosthesis |
| 21 CFR 888.3535 | NJD | Knee joint femorotibial (uni-compartmental)
metal/polymer porous-coated uncemented prosthesis |
| 21 CFR 888.3560 | OIY | Knee joint patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis. |
Reason for 510(k) submission:
Special 510(k): Device modification with no change to fundamental scientific technology or intended use
Device Modification:
- . Addition of Sequentially Cross-linked and Annealed UHMWPE (X3) onlay tibial insert
- Gas Plasma Sterilization ●
- Packaging ●
Device Description:
The RESTORIS® Porous Partial Knee System is a knee joint femorotibial (unicompartmental) prosthesis. The RESTORIS® Porous Partial Knee System consists of femoral components and tibial baseplate components that are compatible with and
4
intended for use with MAKO's predicate RESTORIS MCK Tibial Onlay Insert Components (K090763 or K133039).
The RESTORIS® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.
The Porous Femur components: sizes 1 through 8, CoCr with a CoCr porous coating for cementless fixation, asymmetric design (meaning that left medial implants can be used on the right lateral compartment and right medial implants can be used on the left lateral compartment; abbreviated hereafter as LM/RL and RM/LL)
PST® Tibial Baseplate components: sizes 1 through 8. Ti6Al4V allov with MAKO's predicate porous surface (porous structured technology, referred to as "PST®"), asymmetric (LM/RL-RM/LL).
Intended Use:
The RESTORIS ® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:
- . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. ●
The RESTORIS ® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.
Substantial Equivalence:
The RESTORIS ® Porous Partial Knee System is substantially equivalent to the following 510(k) cleared devices.
| Device Name | Manufacturer | 510(k) # |
|---|---|---|
| RESTORIS ® Porous Partial Knee System | MAKO | K133811 |
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Technological Characteristics:
The RESTORIS® Porous Partial 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® Porous Partial 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 ●
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.