degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
. post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
. moderate valgus, varus or flexion deformities;
. treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts.

This system is to be used for cemented applications

Device Description

The purpose of this application is to include a new domed design patella for the Foundation and 3DKnee systems manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.

AI/ML Overview

The provided document K121835 is a 510(k) summary for a medical device (Domed Tri-Peg Patella), which is a premarket submission to the FDA. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for establishing new acceptance criteria and proving performance through a clinical study in the way a PMA (Premarket Approval) submission would.

In this specific 510(k) summary:

Acceptance Criteria and Reported Device Performance: This information is not provided in the context of the requested table. A 510(k) summary focuses on demonstrating equivalence to predicate devices, primarily through non-clinical testing for mechanical properties and material compatibility, rather than setting and meeting specific clinical performance acceptance criteria. The document states "Non-Clinical Testing: Previous mechanical testing outlined in K113756 demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, push out, lever out, torsion, Izod impact, small punch, tensile, FTIR, wear, animal implant for toxilogical response, and cytotoxicity." These are general mechanical and biocompatibility tests, not specific clinical acceptance criteria for diagnostic accuracy or effectiveness.
Clinical Testing: The document explicitly states: "Clinical Testing: None provided." This means no human subject study was conducted to establish new clinical performance or acceptance criteria for this specific device in this submission. Therefore, none of the subsequent questions related to clinical study design, sample size, ground truth, or expert involvement can be answered from this document.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Given that no clinical testing was performed, an MRMC study was also not conducted.
Standalone Performance: Not applicable, as no standalone clinical performance study was conducted.
Ground Truth Type: Not applicable, as no clinical study was performed that would require ground truth.
Training Set Sample Size and Ground Truth Establishment (for a clinical study): Not applicable, as no clinical study was performed.

In summary, the provided 510(k) document is for a device seeking substantial equivalence based on prior predicate device testing and non-clinical mechanical/material testing. It does not contain information on acceptance criteria and a study proving the device meets those criteria in a clinical context, as explicitly stated by "Clinical Testing: None provided."

Summary

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K121835

510(k) Summary

JUL 20 2012

Date: July 12, 2012

Manufacturer:

Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758

Contact Person: Michaela Norris Regulatory Affairs Associate Phone: (512) 834-6291 Fax: (512) 834-6313 Email: michaela.norris@djoglobal.com

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ProductCode	Regulation and Classification Name
JWH	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560
OIY	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3560

· Regulation Number/Name

21 CFR 888.3560 - Knee joint patellofemoratibial polymer semi-constrained cemented prosthesis.

Description: The purpose of this application is to include a new domed design patella for the Foundation and 3DKnee systems manufactured with both the standard UHMWPE and highly crossed linked UHMWPE infused with Vitamin E.

Indications for Use:

Joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
. post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
. moderate valgus, varus or flexion deformities;
. treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts.

This system is to be used for cemented applications

Predicate Devices:

DJO Surgical Domed Tri-Peg Patella - K905613

DJO Surgical Movation Domed Patella - K100900

DJO Surgical 3DKnee Standard Poly Material - K020114

DJO Surgical e+ Patella HXL VE Poly - K113756

DJO Surgical 3DKnee Sterilization and Packaging of Standard Poly - K020114

DJO Surgical e+ Patella Sterilization and Packaging of HXL VE Poly - K113756

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Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications sterilization, packaging and intended use.

Non-Clinical Testing: Previous mechanical testing outlined in K 1 13756 demonstrated the device's ability to perform under expected conditions. Testing included mechanical characterization testing, push out, lever out, torsion, Izod impact, small punch, tensile, FTIR, wear, animal implant for toxilogical response, and cytotoxicity.

Clinical Testing: None provided.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol of care and protection. The logo is black and white.

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

Encore Medical, L.P. % Ms. Michaela Norris Regulatory Affairs Associate 9200 Metric Boulevard Austin, Texas 78758

JUL 20 2012

Re: K121835

Trade/Device Name: Domed Tri-Peg Patella 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: June 22, 2012 Received: June 22, 2012

Dear Ms. Norris:

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 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

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

Page 2 - Ms. Michaela Norris

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,

FOR Ant. Macedo

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Domed Tri-Peg Patella

Indications for Use:

Domed Tri-Peg Patella Indications for Use

Joint replacement is indicated for patients suffering from disability due to:

degenerative, post-traumatic or rheumatoid arthritis; .
avascular necrosis of the femoral condyle; .
post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, . dysfunction or prior patellectomy;
moderate valgus, varus or flexion deformities; �
treatment of fractures that are unmanageable using other techniques. .

This device may also be indicated in the salvage of previously failed surgical attempts.

This system is to be used for cemented applications

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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, Orthopedic, and Restorative Devices

510(k) Number K121835

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.