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
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.

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.

AI/ML Overview

The provided text is a 510(k) summary for "The KINETIS™ Total Knee System." It describes the device, its intended use, predicate devices, and a list of performance tests conducted. However, it does not provide specific acceptance criteria or detailed results of these tests in a manner that allows for the creation of a table comparing acceptance criteria to reported device performance.

Specifically, the document states:

"The Kinetis™ Total Knee System has been evaluated through non-clinical performance testing for;..." followed by a list of tests.
"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 information confirms that performance testing was done, but it does not list quantitative acceptance criteria for each test or the specific numerical results obtained from these tests. Without this specific data, a table comparing acceptance criteria to reported performance, as requested, cannot be generated from the given text.

Furthermore, the document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device through non-clinical and sometimes clinical data. It is not a detailed study report.

Therefore, for the points requested:

A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document only lists the types of performance tests conducted.

For the remaining points, based on the provided text, here's what can be answered:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified. The document mentions "non-clinical performance testing," which typically involves bench testing, not human subjects.
- Data provenance: "Non-clinical performance testing" implies bench testing or mechanical testing, likely conducted in a lab environment. Country of origin is not specified, but the applicant is MAKO Surgical Corporation in Fort Lauderdale, Florida, USA. The testing is not clinical (retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The testing described is "non-clinical performance testing," which does not typically involve expert review for "ground truth" in the way a clinical study would. The performance is assessed against engineering specifications and industry standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical performance testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical knee replacement system, not an AI-assisted diagnostic or therapeutic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical performance testing, the "ground truth" or reference is typically derived from engineering specifications, established biomechanical principles, and comparison to predicate device performance data (if available and relevant for specific tests). The document states "The results of performance testing indicated the device performed within the intended use."
The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. There is no training set.

In summary, the provided document discusses the regulatory submission for a knee replacement system and lists the types of non-clinical performance tests conducted. It explicitly 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." However, it does not detail the specific acceptance criteria or the quantitative results of these tests, nor does it describe a clinical study in the manner requested.

Summary

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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

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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

(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 patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis (888.3560)OIY - Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis (888.3560)
Reason for 510(k) submission:	New device submission

Device Description:

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:

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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 .

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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.

Regulation Number and Section

§ 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.