The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing total knee replacement due to:

. Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
Failed osteotomies, failed partial knee replacement, or failed prior total knee . replacement whose age, weight and activity level are compatible with an adequate long-term result.
. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities. .
Pipeline CR Total Knee System components are indicated for use only with cement and are single use devices.

Device Description

The Pipeline Primary CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation.
The Pipeline CR Total Knee System femoral component, when used with the Pipeline CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

AI/ML Overview

The provided text is a 510(k) Summary for the Pipeline Primary CR Knee System, which is a medical device (total knee system). It does not contain information about acceptance criteria or a study proving the device meets those criteria, as such studies are not typically required or described in a 510(k) summary for this type of device.

510(k) summaries, like this one, primarily focus on demonstrating substantial equivalence to legally marketed predicate devices. This involves comparing the new device's indications for use and technological characteristics (e.g., materials, design features) to those of the predicate devices. Performance testing mentioned in such summaries is usually related to ensuring the device is capable of withstanding anticipated physiological conditions, rather than a clinical study with specific performance metrics against acceptance criteria that would include human-AI interaction or expert review.

Therefore, I cannot fulfill the request to provide acceptance criteria and a study proving the device meets them based solely on the provided input. The prompt's requirements (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) are typical for AI/ML-driven medical device submissions and are not applicable to the Pipeline Primary CR Knee System, which is a physical implant.

In summary, the provided document does not contain the information required to answer the prompt.

Summary

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

Pipeline Primary CR Knee System 510(k) Summarv - K113122

Device Proprietary Name:	Pipeline Primary CR Knee System
Common Name:	Total Knee System
Classification regulation:	888.3560 (implants/instruments)
Device Class:	Class II
Product Codes:	JWH (cemented knees)
Submitter's Name:	Pipeline Orthopedics
Address:	3 Wing Drive, Suite 200, Cedar Knolls, NJ 07927
Contact Person:	Robert C. Cohen
Telephone Number:	(973) 267-8800

(973) 267-8810

Date Summary Prepared: February 16, 2012

Device Description:

Fax Number:

The Pipeline Primary CR Knee System includes components designed for total knee The system includes femoral components, tibial inserts, tibial trays, replacement. patellar components and surgical instrumentation.

The Pipeline CR Total Knee System femoral component, when used with the Pipeline CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

Intended Use:

. Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
Failed osteotomies, failed partial knee replacement, or failed prior total knee . replacement whose age, weight and activity level are compatible with an adequate long-term result.
. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities. ●

Pipeline CR Total Knee System components are indicated for use only with cement and are single use devices.

Page 1 of 2.

{1}------------------------------------------------

Pipeline Primary CR Knee System 510(k) Summary - K113122

Predicate Devices:

The Pipeline Primary CR Knee System is similar to several predicates including the following.

Trade/Proprietary Name	Manufacturer	510(K) #	Clearance Date
NexGen Complete Knee SolutionCruciate Retaining (CR)-Flex FemoralComponents	Zimmer	K023211	10/17/2002
Gender Solutions Natural-Knee FlexSystem	Zimmer	K073286	03/07/2008
Triathlon Cruciate Retaining (Cr) TotalKnee System	Stryker	K040267	5/5/2004

Technological Characteristics:

The metals and standard UHMWPE material from which the components are manufactured are the same materials used in the predicate knee systems and comply with applicable implantable materials standards. A comparison of design features of the Pipeline Primary CR Knee System to the predicate knee systems and performance testing confirm that the Pipeline Primary CR Knee System is capable of withstanding the anticipated physiological conditions associated with the indications for use and is substantially equivalent to the predicate devices.

Substantial Equivalence Information:

The Pipeline Primary CR Knee System is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological characteristics. All evaluations determined that the Pipeline Primary CR Knee System is substantially equivalent to the predicate devices.

Page 2 of 2

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 2 0 2012

Pipeline Orthopedics, Incorporated % M Squared Associates Ms. Terry Sheridan Powell Consultant 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K113122

Trade/Device Name: Pipeline Cruciate Retaining (CR) Primary 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 Dated: March 16, 2012 Received: March 19, 2012

Dear Ms. Powell:

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 (21

{3}------------------------------------------------

Page 2 - Ms. Terry S. Powell

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/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 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 yours

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number: K113122

Pipeline Primary CR Knee System Device Name:

Indications for Use: The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing total knee replacement due to:

. Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
Failed osteotomies, failed partial knee replacement, or failed prior total knee . replacement whose age, weight and activity level are compatible with an adequate long-term result.
. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities. .

Pipeline CR Total Knee System components are indicated for use only with cement and are single use devices.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical. Innopedie, and Kestorative Devices

510(k) Number K113122

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.