K Number

Device Name

GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT

Manufacturer

SMITH & NEPHEW, INC.

Date Cleared

2003-08-21

(27 days)

Product Code

JWH

Regulation Number

888.3560

Intended Use

The Genesis II Posterior Stabilized High Flexion Articular Insert is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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 Posterior Stabilized High Flexion 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 Posterior Stabilized High Flexion Articular Insert is for single use only. The Genesis II Posterior Stabilized High Flexion 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 Posterior Stabilized High Flexion Articular Insert is for single use only.

Device Description

The Genesis II Posterior Stabilized High Flexion Articular Inserts are URMWPE 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K951987, K953274, K030612, K991581

Reference Devices

K951987, K953274, K030612

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical medical device (a knee implant component) and its intended use and mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The device is an articular insert for a total knee replacement system, indicated for various forms of arthritis and failed previous surgeries, which are conditions that it aims to alleviate or correct.

Diagnostic

Explanation: The Genesis II Posterior Stabilized High Flexion Articular Insert is a medical device designed for total knee replacement, intended to replace damaged or diseased knee joints and restore function. It does not provide information about the patient's health status or disease, which is the function of a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly states it is a "URMWPE tibial component," which is a physical implant, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The provided text describes a Genesis II Posterior Stabilized High Flexion Articular Insert, which is a component of a total knee replacement system. It is a physical implant designed to be surgically placed in the knee joint.
Intended Use: The intended use clearly states that this device is for treating conditions like arthritis and failed knee replacements by being implanted into the knee.
No mention of testing samples: There is no indication in the description or intended use that this device is used to analyze samples from the body.

Therefore, based on the provided information, the Genesis II Posterior Stabilized High Flexion Articular Insert is a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Genesis II Posterior Stabilized High Flexion Articular Insert 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 Posterior Stabilized High Flexion Articular Insert 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 Posterior Stabilized High Flexion 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 Posterior Stabilized High Flexion Articular Insert is for single use only.

Product codes (comma separated list FDA assigned to the subject device)

JWH, MBH

Device Description

The Genesis II Posterior Stabilized High Flexion Articular Inserts are URMWPE tibial components which provide the ability for greater flexion to those patients who bave the anatomical capability to allow a greater flexion range. The insect 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee joint

Indicated Patient Age Range

older patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K951987, K953274, K030612, K991581

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

AUG 21 2003

K032295

p. 1/2

Smith & Nephew, Inc. Summary of Safety and Effectiveness Genesis II P/S High Flexion Articular Insert

Date of Summary: August 20, 2003

Contact Person and Address Jason Sells Regulatory/Clinical Affairs Specialist I Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116

Name of Device: Genesis II Postcrior Stabilized High Flexion Articular Insert Common Name: Articular insert

Device Description

(901) 399-5520

| Identification of

Device	Product Code	Classification Name
Genesis II PS
High Flex Insert
for use with
Genesis II Total
Knee System
Components in
cemented
applications	JWH -
Orthopedics
Panel/87	Knee joint
patellofemorotibial
polymer/metal/polymer
semi-constrained
cemented prosthesis -
Class II	21 CFR
888.3560	K951987
K953274	Identification of Device	Indications for Use
Genesis II PS
High Flex Insert
for use with
Genesis II Total
Knee System
Components in
uncemented
applications	MBH -
Orthopedics
Panel/87	Knee joint
patellofemorotibial
metal/polymer porous-
coated uncemented
prosthesis - Class II	21 CFR
888.3565	K030612	Genesis II PS
High Flex Insert
for use with
Genesis II Total
Knee System
Components in
cemented
applications	The Genesis II Posterior Stabilized High Flexion Articular Insert
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 Posterior Stabilized High Flexion 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 Posterior Stabilized High
Flexion Articular Insert is for single use only. | K951987
K953274 |
| Genesis II PS
High Flex Insert
for use with
Genesis II Total
Knee System
Components in
uncemented
applications | The Genesis II Posterior Stabilized High Flexion Articular Insert
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 inpatients 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 Posterior Stabilized High Flexion 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 Posterior Stabilized
High Flexion Articular Insert is for single use only. | K030612 | | | | | |

Device Classification

K032295

p. 2/2

Mechanical and Clinical Data

Substantial Equivalence Information

The substantial equivalence of the Genesis II Posterior Stabilized High Flexion Articular Insert is based on its similarities in indications for use, design features, operational principles, and material composition to the following prodicate devices - Smith & Nephew's Genesis II Total Knee System (K951987, K953274, K030612) and Zimmer's Nexgen LPS Knee System (K991581).

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2003

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

Re: K032295

Trade/Device Names: Genesis II PS High Flex Insert for use with Genesis II Total Knee System Components in cemented applications and Genesis II PS High Flex Insert for use with Genesis II Total Knee System Components in uncemented applications Regulation Numbers: 21 CFR 888.3560 and 21 CFR 888.3565 Regulation Names: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis and Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Codes: JWH and MBH

Dated: July 24, 2003 Received: July 25, 2003

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 10 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.

Page 2 - Mr. Jason Sells

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark A. Mcllhenny

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

K032295

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Genesis II Posterior Stabilized High Flexion Articular Insert Indications Statement

The Genesis II Posterior Stabilized High Flexion Articular Insert is indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
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 absent or incompetent and the collateral ligaments remain intact.

Mark N Millenn

ivision Sion-Division of General, Restorative and Neurological Devices 510(k) Number -

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

K032295

p. 2/2

Genesis II Posterior Stabilized High Flexion Articular Insert Indications Statement

The Genesis II Posterior Stabilized High Flexion Articular Insert is indicated for:

1. Rheumatoid arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
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 absent or incompetent and the collateral ligaments remain intact.

Mark N Milken

Orvision of General. Restorative and Neurological I

510(k) Number .

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) ાર

Over-the-Counter Use