The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System.

The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact.

The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.

The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee System cleared via K030612. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.

Device Description

The Genesis II Deep Flexion Cruciate Retaining Articular Inserts are UHMWPE tibial components which provide the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibial tray components cleared in K030612.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert:

Acceptance Criteria and Device Performance

This 510(k) submission primarily relies on substantial equivalence to predicate devices. As such, the "acceptance criteria" are not explicitly defined as numerical thresholds for specific performance metrics in the same way they might be for a novel device or a detailed clinical trial. Instead, the acceptance criteria are implicitly that the new device performs equivalently to the predicate devices in terms of its mechanical properties and intended use.

The study presented is a mechanical test data review rather than a human-involved clinical study.

Acceptance Criteria Category	Reported Device Performance
Mechanical Strength & Durability	"capable of withstanding expected in vivo loading without failure"
Equivalence to Existing Devices	"equivalent to devices currently used clinically"
Indications for Use (same as predicate)	Substantially equivalent to predicate devices (K951987, K953274, K030612, K032295)
Design Features (similar to predicate)	Substantially equivalent to predicate devices
Operational Principles (similar to predicate)	Substantially equivalent to predicate devices
Material Composition (similar to predicate)	Substantially equivalent to predicate devices

Study Details

Given the nature of this 510(k) summary, which focuses on substantial equivalence based primarily on mechanical testing, many of the typical clinical study parameters are not applicable.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices. The study refers to "mechanical test data" for the device, implying a set of prototypes or manufactured units were subjected to various tests.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective, though mechanical testing typically occurs in a lab setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is typically established by engineering standards and validated testing protocols, not human expert consensus.
Adjudication method for the test set: Not applicable. Mechanical testing outcomes are typically objectively measured against established engineering specifications, not adjudicated by human experts.
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 knee implant component, and this type of study is irrelevant to its evaluation.
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.): The "ground truth" for the mechanical testing would be the established engineering requirements, material properties, and performance benchmarks derived from predicate devices, demonstrated through validated mechanical and material testing.
The sample size for the training set: Not applicable. There is no "training set" as this is not an AI or algorithm-based device.
How the ground truth for the training set was established: Not applicable.

Summary

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Smith & Nephew, Inc. Summary of Safety and Effectiveness Genesis II Deep Flexion Cruciate Retaining Articular Insert

Contact Person and Address

Date of Summary: July 6, 2004

Kim Kelly Project Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 (901) 399-6566

W/R/1 2005

Name of Device: Genesis II Deep Flexion Cruciate Retaining Articular Insert Common Name: Articular insert

Device Description

Identification of Device	Product Code	Classification Name	Code	Predicate510(k)	Identificationof Device	Indications for Use	Predicate510(k)
Genesis II Deep FlexionC/R Insert for use withGenesis II Total KneeSystem Components incemented applications	JWH -OrthopaedicsPanel/87	Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis -Class II	21 CFR888.3560	K951987 K953274	Genesis IIDeep FlexionC/R Insert foruse withGenesis IITotal KneeSystemComponentsin cementedapplications	The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended tobe used in conjunction with the components of the Genesis II Total KneeSystem.The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patientswhose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total kneereplacement. Posterior stabilized knee systems are designed for use inpatients in primary and revision surgery, where the anterior and posteriorcruciate ligaments are absent or incompetent and the collateral ligamentsremain intact.The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used withexisting cemented femoral, tibial tray, and patellar components of theGenesis II Total Knee System cleared via K951987 and K953274. TheGenesis II Deep Flexion Cruciate Retaining Articular Insert is for single useonly.	K951987 K953274
Genesis II Deep FlexionC/R Insert for use withGenesis II Total KneeSystem Components inuncementedapplications	MBH -OrthopaedicsPanel/87	Knee joint patellofemorotibialmetal/polymer porous-coateduncemented prosthesis - Class II	21 CFR888.3565	K030612	Genesis IIDeep FlexionC/R Insert foruse withGenesis IITotal KneeSystemComponentsinuncementedapplications	The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended tobe used in conjunction with the components of the Genesis II Total KneeSystem.The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patientswhose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total kneereplacement. Posterior stabilized knee systems are designed for use inpatients in primary and revision surgery, where the anterior and posteriorcruciate ligaments are absent or incompetent and the collateral ligamentsremain intact.The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used withexisting cemented patellar and uncemented porous tibial trays and femoralcomponents of the Genesis II Total Knee System cleared via K030612. TheGenesis II Deep Flexion Cruciate Retaining Articular Insert is for single useonly.	K030612

Mechanical and Clinical Data

A review of the mechanical test data indicated that the Genesis II Deep Flexion Cruciate Retaining Articular Insert is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.

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Indications for Use

Substantial Equivalence Information

The substantial equivalence of the Genesis II Deep Flexion Cruciate Retaining Articular Insert is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices - Smith & Nephew's Genesis II Total Knee System (K951987, K953274, and K030612) and the Genesis II P/S High Flexion Articular Insert (K032295).

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo is a circular seal with text around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread. The bird is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

MAR 1 1 2005

Re: K041825

Trade/Device Name: Genesis II Deep Flexion Cruciate Retaining Articular Insert Regulation Number: 21 CFR 888.3560, 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; and Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: JWH, MBH

Dated: February 8, 2005 Received: February 9, 2005

Dear Mr. Sells:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Mr. Jason Sells

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IN Fart 6077, laboring (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manisting of substantial equivalence of your device to a legally premailted predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrioliance at (240) 276-0120. Also, please note the regulation entitled, eonaler the Orition of Computible to the transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mack A. Millican

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Genesis II Deep Flexion Cruciate Retaining Articular Insert

Indications for Use:

The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in
the Genesis II Deep Flexion Cruciall Total Knoo System The Genesis II Beep Ronton Crain Crain Crain II Total Knee System.

The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, post-traumatic arthritis, The Genesis II Total Knee System is Indicated for moder age, weight, and activity level are
osteoarthritis, or degenerative arthritis in older patients whose age, weigement osteoarthritis, or degenerative annifilis in three ages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - compatible with an adequare long-term resort, lance systems are designed for use in patients in patients in patients in or total knee replacement. Postenor stablized know of each of the ligaments are absent or primary ond the collateral ligaments remain intact.

The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented
Santa Cruciate Retaining Articular of the Canasia II Total Knoo System cleared The Genesis II Deep Flexion Cruciale Netaining Fri. In Total Knee System cleared via
femoral, tibial tray, and patellar components of the Genesis II Total Kneed in the femoral, fibial tray, and patellar components of the Genesis II.
K951987 and K953274. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.

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

Over-The-Counter Use 121 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)

storative. and Neurological

510(k) Number K041825

Page 1 of _

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Indications for Use

510(k) Number (if known):

Device Name: Genesis II Deep Flexion Cruciate Retaining Articular Insert

Indications for Use:

The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System.

The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, me Ocheolo il Total Ande Bysterthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, componible with an odequate ting castems are designed for use in patients in or total replacement. It , where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.

The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee pattern cleared via K030612. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.

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)

Muk N Miller
Division Sign Off

Division of General, Restorative,
and Neurological Devices

10(k) Number K041825

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.