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.

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).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the RESTORIS® Porous Partial Knee System. It focuses on demonstrating substantial equivalence to a predicate device based on manufacturing materials, design, technological characteristics, and performance data.

However, this document does not contain the information requested regarding acceptance criteria and the study proving a device meets them in the context of AI/ML performance. The device described is a physical knee implant, not an AI-powered diagnostic or therapeutic tool.

Therefore, I cannot extract the following information from this document:

A table of acceptance criteria and the reported device performance: This document reports on non-clinical performance testing for a physical implant (e.g., snaplock strength, micromotion, wear), not AI model metrics like sensitivity, specificity, or AUC.
Sample size used for the test set and the data provenance: Not applicable to this type of device submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical implant, not an AI-assisted diagnostic.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to physical implant performance testing in this context.
The sample size for the training set: Not applicable (no AI model).
How the ground truth for the training set was established: Not applicable (no AI model).

The "Performance Data" section lists non-clinical performance testing related to the physical characteristics and function of the knee implant, such as:

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

The conclusion states that "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." This is the general "acceptance" for a 510(k) submission for this type of device, demonstrating it functions as intended and is as safe and effective as a legally marketed predicate. However, detailed, quantitative acceptance criteria for each test (e.g., "snaplock strength > X N") are not provided in this summary, nor are the specific results for each test.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

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)
-----------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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 FederalRegulations	Productcode	Description
21 CFR 888.3530	HRY	Knee joint femorotibial metal/polymer semi constrainedcemented 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/polymersemi-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:

{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.

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. ●

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

{5}------------------------------------------------

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.

Regulation Number and Section

§ 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.