The Genesis II XLPE Resurfacing Patellar Components are intended to be used with Smith & Nephew Total Knee Systems and Patello-Femoral Replacement Knee Systems and their cleared Indications for Use.

Indications for Total Knee Replacement

Rheumatoid arthritis.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

Indications for Patello-Femoral Replacement

Degenerative arthritis in the distal femur and patella;
A history of patellar dislocation or patellar fracture; and
Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Device Description

Subject of this Premarket Notification are the Genesis II XLPE resurfacing patellar components manufactured from highly cross linked polyethylene (XLPE) material. The Genesis II XLPE resurfacing patellar components are intended to be used with the following knee systems

Smith & Nephew Total Knee Systems
Smith & Nephew Patello-Femoral Knee Systems
Competitor PFJ Patella-Femoral Knee Implants K051086
Legion Hinge Knee System K081111
Genesis II Constrained System K962137

Components of this premarket notification include

Round and Oval Patellar components manufactured from highly cross-linked polyethylene (7.5 Mrad XLPE) material.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Genesis II XLPE Resurfacing Patellar Components. It is a regulatory submission to the FDA, demonstrating substantial equivalence to previously cleared devices. It describes mechanical testing performed to support a material change, not a study proving a device meets specific clinical acceptance criteria or a comparative effectiveness study.

Therefore, many of the requested sections in your prompt (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance, type of ground truth) are not applicable or not explicitly detailed in this type of regulatory submission. The document focuses on showing mechanical equivalency rather than clinical performance.

However, I can extract information related to the acceptance criteria for the mechanical testing and the reported performance from the document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the mechanical tests (Static Shear and Fatigue Shear Testing). Instead, it states that the tests were conducted "to further support a determination of substantial equivalence" and that "Test results demonstrated that the proposed devices are substantially equivalent to the previously cleared predicate device." This implies that the acceptance criterion was the demonstration of performance comparable to the predicate device, although the specific thresholds for "comparable" are not provided.

Acceptance Criteria Category	Specific Acceptance Criteria (as implied)	Reported Device Performance
Mechanical Performance	Performance comparable to the previously cleared predicate device for material properties.	"Test results demonstrated that the proposed devices are substantially equivalent to the previously cleared predicate device." (for both Static Shear and Fatigue Shear Testing)
Material Change	Highly cross-linked polyethylene (XLPE) material properties are equivalent to the material in reference predicate K071071.	The change in material to highly cross-linked polyethylene is "identical to the material in reference predicate K071071."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the document.
Data Provenance: Not explicitly stated, but these would be bench (mechanical) tests performed in a laboratory setting, likely by Smith & Nephew or a contracted testing facility. This is not clinical data (retrospective or prospective from a country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in this context would refer to clinical or diagnostic accuracy, which is not evaluated here. The "truth" for mechanical testing is derived from engineering principles and standards, not expert clinical consensus.

4. Adjudication method for the test set

Not Applicable. This is not a clinical study involving human assessment that would require adjudication. Mechanical tests have objective outputs that are compared against predefined engineering specifications or predicate device performance.

5. 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

No. This is a submission for a medical implant (knee replacement components), not an AI diagnostic device. Therefore, no MRMC comparative effectiveness study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not a software algorithm; it is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Engineering Standards. For mechanical testing, the "ground truth" would be established by industry-accepted mechanical testing standards (e.g., ISO, ASTM) and comparison to the known performance characteristics of the predicate device, rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. (See #8)

Summary

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

October 28, 2015

Smith & Nephew, Incorporated Allison Chan Regulatory Affairs Specialist 7135 Goodlett Farms Parkways Cordova, Tennessee 38018

Re: K150241

Trade/Device Name: Genesis II XLPE Resurfacing Patellar Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, KRO, KRR Dated: September 25, 2015 Received: September 28, 2015

Dear Ms.Chan:

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. Iisting 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

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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 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150241

Device Name

Genesis II XLPE Resurfacing Patellar Components

Indications for Use (Describe)

The Genesis II XLPE Resurfacing Patellar Components are intended to be used with Smith & Nephew Total Knee Systems and Patello-Femoral Replacement Knee Systems and their cleared Indications for Use.

Indications for Total Knee Replacement

Rheumatoid arthritis.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
Failed osteotomies, unicompartmental replacement, or total knee replacement.
Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are incomnetent.
Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral collateral ligament) are absent or incompetent.

Indications for Patello-Femoral Replacement

Degenerative arthritis in the distal femur and patella;
A history of patellar dislocation or patellar fracture; and
Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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	510(k) SummaryGenesis II XLPE Resurfacing Patellar Components
Submitted by:	Smith & Nephew, Inc.1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	March 25, 2015
Contact Person and Address:	Allison ChanRegulatory Affairs SpecialistT 901-399-1098F 901-566-7022
Name of Device:	Genesis II XLPE Resurfacing Patellar Components
Common Name:	Knee prosthesis
Device Classification Name andReference:	21 CFR 888.3560 Knee joint patellofemorotibialmetal/polymer/metal semi-constrained cementedprosthesis
	21 CFR 888.3565 Knee joint patellofemorotibialmetal/polymer porous-coated uncemented prosthesis
	21 CFR 888.3510 Knee joint femorotibial metal/polymerconstrained cemented prosthesis
	21 CFR 888.3540 Knee joint patellofemoralpolymer/metal semi-constrained cemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	JWH, MBH, KRO, KRR

Device Description

Smith & Nephew Total Knee Systems ●
Smith & Nephew Patello-Femoral Knee Systems
Competitor PFJ Patella-Femoral Knee Implants K051086 .
Legion Hinge Knee System K081111 ●
Genesis II Constrained System K962137 ●

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Components of this premarket notification include

. Round and Oval Patellar components manufactured from highly cross-linked polyethylene (7.5 Mrad XLPE) material.

Intended Use

The Genesis II XLPE Resurfacing Patellar Components are intended to be used with Smith & Nephew Total Knee Systems and Patello-Femoral Replacement Knee Systems and their cleared Indications for Use.

Indications for Total Knee Replacement

Rheumatoid arthritis. 1.
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
1. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
1. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

Indications for Patello-Femoral Replacement

Degenerative arthritis in the distal femur and patella; 1.
1. A history of patellar dislocation or patellar fracture; and
1. Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Comparison of Technological Characteristics with the Predicate Device

The Genesis II XLPE resurfacing patellar components are substantially equivalent in design and fundamental scientific technology to the defined predicate devices and do not raise any new issues of safety and efficacy. At a high level, the subject and predicate devices are based on the following same technological elements

. Use only with cement and single use
Same articular and cement interface geometry .

No technological differences exist between the subject and predicate device.

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

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Mechanical Testing

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted to support the material change from conventional polyethylene to highly cross linked polyethylene (XLPE) on the Genesis II resurfacing patellar components. Test results demonstrated that the proposed devices are substantially equivalent to the previously cleared predicate device. The specific types of non-clinical testing conducted are listed below.

Static Shear Testing
. Fatigue Shear Testing

Substantial Equivalence Information

The substantial equivalence of the Genesis II XLPE resurfacing patellar components is based on it similarities in the indications for use, design feature, and operational principles to the predicate systems listed in the table below. In addition the change in material to highly crosslinked polyethylene is identical to the material in reference predicate K071071.

Design AspectReviewed	Genesis II XLPEresurfacing patellarcomponents	Genesis II KneeSystem	Anthem TotalKnee System
510(k) Number	Subject 510(k)	K951987	K142807
Predicate Type	Not Applicable	Primary	Primary
Manufacturer	Smith & Nephew	Smith & Nephew	Smith & Nephew
Similar Indicationsfor Use	Yes	Yes	Yes
SimilarSterilizationMethods	Yes	Yes	Yes
ArticulatingSurface	Round and oval	Round	Round and oval
Material	XLPE	Patellarcomponents -UHMWPE	Patellarcomponents -UHMWPE

Table 5.1: Substantially Equivalent Primary Predicates to the Genesis II XLPE Resurfacing Patellar Components

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is submitted to request clearance for the modified Genesis II XLPE resurfacing patellar components. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the above predicate knee systems.

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.