A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.
All MILESTONE Knee components are intended for cemented use only.

Device Description

The MILESTONE Knee System (MKS) is a primary, fixed-bearing, total knee system designed to replicate the natural anatomy of the knee in order to restore knee function. It was developed to preserve and utilize healthy ligamentous structures, and to restore stability to the knee.
The MKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The femoral and tibial components are provided in left and right configurations. The femoral component is made from CoCr and is offered in a posterior stabilizing (PS) configuration. The tibial component comprises an asymmetric tibial baseplate made from CoCr alloy and an asymmetric PS tibial insert made from UHMWPE. The baseplate is designed to maximize metaphyseal bone coverage on the tibia. The baseplate employs a cruciate type keel to enhance implant fixation and torsion resistance. The tibial insert attaches to the baseplate via a mechanical locking mechanism. All MKS metallic components are available in uncoated variants for cemented use. The patellar component is an all-poly round patella made from UHMWPE, also intended for cemented use.

AI/ML Overview

The provided document describes the TGM Medical, Inc. MILESTONE Knee System (MKS) and its substantial equivalence to a legally marketed predicate device, the Consensus Knee System (CKS). It is a traditional 510(k) premarket notification.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Equivalence in Materials	MKS components employ identical materials as their respective predicate CKS components.
Equivalence in Design Features	MKS components employ identical geometry and design features as their respective predicate CKS components.
Biomechanical Performance (Safety & Effectiveness)	Biomechanical testing of predicate CKS components validated the safety and effectiveness for MKS.
Indicated Uses	Indications for Use are identical to the predicate device.

Note: The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail sense, but rather establishes equivalence through material, design, and prior testing of predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (for the MKS itself): Not applicable in the traditional sense of a clinical trial with a "test set" of patients.
Data Provenance: The "testing" referred to is non-clinical bench testing and analyses performed on predicate CKS components. The document does not specify the sample size for these predicate tests, nor does it mention a specific country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This submission is based on substantial equivalence to a predicate device, relying on prior regulatory clearances and non-clinical bench testing of the predicate. There is no mention of a human expert-based ground truth establishment for a "test set" in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. As there is no clinical trial with a "test set" requiring expert ground truth or adjudication described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study was not done. The submission relies on establishing substantial equivalence to a predicate device through non-clinical testing and material/design comparisons, not comparative effectiveness studies with human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a total knee prosthesis, a physical implant, not an algorithm or AI software. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the safety and effectiveness of the MKS is established through:
- Prior Regulatory Clearance of Predicate Devices: The FDA's clearance of the predicate CKS components (K954818, K110950, K932837, K001456, K945589) serves as the primary "ground truth" for their safety and effectiveness.
- Biomechanical Testing of Predicate Devices: The non-clinical bench testing performed on the predicate CKS components validates their safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (knee prosthesis), not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a training set is not relevant for this type of device submission.

Summary of Acceptance Criteria and Evidence from the Document:

The MILESTONE Knee System demonstrates meeting what could be interpreted as "acceptance criteria" by establishing substantial equivalence to existing, legally marketed predicate devices. The key argument is that the MKS components employ identical materials, geometry, and design features as corresponding components of the Consensus Knee System (CKS). Therefore, the non-clinical bench testing and analyses previously conducted for the CKS components are considered sufficient to validate the safety and effectiveness of the MKS. No new clinical or non-clinical testing unique to the MKS components was deemed necessary because of this identity with the predicate.

Summary

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K112285 1/2

TGM Medical, Inc. Premarket Traditional 510(k) Notification: MILESTONE Knee System

1. 510(k) SUMMARY

Sponsor Name:	TGM Medical, Inc.5145 Golden Foothill Parkway, Suite 175 & 180El Dorado Hills, CA 95762
510(k) Contact:	Dennis CranePhone: 952.374.6012 / Fax: 952.374.6001dennisc@emersonconsultants.com
Date Prepared:	08/08/2011
Trade Name:	MILESTONE Knee System (MKS)
Common Name:	Total knee prosthesis
Classification Name:	Knee joint patellofemorotibial metal/polymer/metal semi-constrained cemented prosthesis (21 CFR 888.3560, Class IIdevice, Product Code JWH).
Review Panel:	Orthopedic Devices

Device Description:

The MKS incorporates femoral, tibial, and patellar components and all associated instrumentation needed for implantation. The femoral and tibial components are provided in left and right configurations. The femoral component is made from CoCr and is offered in a posterior stabilizing (PS) configuration. The tibial component comprises an asymmetric tibial baseplate made from CoCr alloy and an asymmetric PS tibial insert made from UHMWPE. The baseplate is designed to maximize metaphyseal bone coverage on the tibia. The baseplate employs a cruciate type keel to enhance implant fixation and torsion resistance. The tibial insert attaches to the baseplate via a mechanical locking mechanism. All MKS metallic components are available in uncoated variants for cemented use. The patellar component is an all-poly round patella made from UHMWPE, also intended for cemented use.

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K11 2285 2/3

Indications for Use:

The MILESTONE Knee System Primary Knee is designed as a system and is not intended for substitution of components from other systems.

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
B. Failed osteotomy or unicompartmental replacements.
C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

All MILESTONE Knee components are intended for cemented use only

Substantial Equivalence:

Technological Characteristics/Substantial Equivalence:

Consensus Orthopedics, Inc. (COI) licensed the previously cleared Consensus Knee System (CKS) posterior stabilized (PS), standard, uncoated femoral component (K954818), the CKS PS, reduced lateral profile (RLP), uncoated femoral component (K110950), the CKS PS tibial insert (K954818), the CKS uncoated, pegless, CoCr tibial baseplate (K001456), and the CKS round, all-poly patella (K932837) to TGM Medical for use as the MILESTONE Knee System (MKS). These predicate knee system components employ identical materials, design features, and indications as the respective MKS components. Therefore, the femoral, tibial, and patellar components used with the MKS are substantially equivalent to legally marketed predicate devices (Table 2.1).

510(k)Number	Trade Name	510(k) holder	510(k)Clearance
K932837	Consensus Knee System - PrimaryKnee	U.S. Medical Products, Inc.	09/27/1994*
K945589	Consensus® Knee Cobalt ChromeNonporous Stemmed Tibial Baseplate	U.S. Medical Products, Inc.	05/31/1995*
K954818	Consensus Posterior Stabilized Knee	U.S. Medical Products, Inc.	05/22/1996*
K001456	Consensus® Knee System: TibialBaseplate, Cast, CoCr/Ti Porous andCoCr Non-Porous	Hayes Medical, Inc.	08/07/2000**
K110950	Consensus Knee System: ReducedLateral Profile (RLP) PosteriorStabilizing (PS) non-porous femoralcomponent	Consensus Orthopedics	06/27/2011

Table 2.1: Legally marketed devices to which substantial equivalence is claimed

Notes: * Cleared prior to the purchase of U.S. Medical Products by Hayes Medical in 1996. ** Cleared prior to the change in company name from Hayes Medical to Consensus Orthopedics in 2008.

-..

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K112285 3/3

TGM Medical, Inc. Premarket Traditional 510(k) Notification: MILESTONE Knee System

Non-Clinical Performance Data:

The MILESTONE Knee System (MKS) implant components were evaluated using Failure Modes and Effects Analysis (FMEA) and biomechanical testing of its predicate CKS components. MKS components employ identical geometry and material characteristics as those employed by their respective predicate CKS components. Therefore, non-clinical bench testing and analyses were provided for these predicate components to validate the safety and effectiveness of the MKS. Further testing of MKS components was deemed unnecessary.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV - 4 2011

TGM Medical, Inc. % Mr. Dennis Crane Vice President, Clinical & Regulatory Services Emerson Consultants, Inc. 12701 Whitewater Drive, Suite 120 Minnetonka, Minnesota 55343

Re: K112285

Trade/Device Name: MILESTONE Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II

Product Code: JWH Dated: August 8, 2011 Received: August 9, 2011

Dear Mr. Crane:

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

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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 (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/MedicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

~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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1. INDICATIONS FOR USE STATEMENT

KII2285 510(k) Number (if known):

Device Name: MILESTONE Knee System

Indications for Use:

The MILESTONE Knee System Primary Knee is designed as a system and is not intended for substitution of components from other systems.

A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis.
- B. Failed osteotomy or unicompartmental replacements.
- C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

All MILESTONE Knee components are intended for cemented use only.

Prescription Use X (21 CFR Part 801 Subpart D)

AND/OR

Over the Counter Use ___________ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

E.V. Keith

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112285

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.