SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT
K041825 · Smith & Nephew, Inc. · JWH · Mar 11, 2005 · Orthopedic
Device Facts
Record ID
K041825
Device Name
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT
Applicant
Smith & Nephew, Inc.
Product Code
JWH · Orthopedic
Decision Date
Mar 11, 2005
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3560
Device Class
Class 2
Attributes
Therapeutic
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, 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 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. 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.
Device Story
Genesis II Deep Flexion Cruciate Retaining Articular Insert; UHMWPE tibial component; used with Genesis II Total Knee System components (cemented or porous/uncemented). Enables greater flexion range for patients with anatomical capability. Single-use device; implanted by orthopedic surgeons in clinical/hospital settings. Provides articular surface for knee joint; facilitates joint motion; supports long-term knee function. Benefits include improved range of motion for eligible patients.
Clinical Evidence
Bench testing only. Mechanical test data indicates the device is equivalent to currently used clinical devices and capable of withstanding expected in vivo loading without failure.
Technological Characteristics
UHMWPE tibial component; semi-constrained; designed for use with Genesis II Total Knee System femoral, tibial tray, and patellar components. Single-use.
Indications for Use
Indicated for rheumatoid, post-traumatic, or degenerative arthritis in older patients with compatible age, weight, and activity levels; failed osteotomies; unicompartmental or total knee replacement. Posterior stabilized systems indicated for primary/revision surgery where anterior/posterior cruciate ligaments are absent/incompetent and collateral ligaments remain intact.
Regulatory Classification
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).
Genesis II P/S High Flexion Articular Insert (K032295)
Submission Summary (Full Text)
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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
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.
| Identification of Device | Product Code | Classification Name | Code | Predicate<br>510(k) | Identification<br>of Device | Indications for Use | Predicate<br>510(k) |
|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Genesis II Deep Flexion<br>C/R Insert for use with<br>Genesis II Total Knee<br>System Components in<br>cemented applications | JWH -<br>Orthopaedics<br>Panel/87 | Knee joint patellofemorotibial<br>polymer/metal/polymer semi-<br>constrained cemented prosthesis -<br>Class II | 21 CFR<br>888.3560 | K951987<br>K953274 | Genesis II<br>Deep Flexion<br>C/R Insert for<br>use with<br>Genesis II<br>Total Knee<br>System<br>Components<br>in cemented<br>applications | The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to<br>be used in conjunction with the components of the Genesis II Total Knee<br>System.<br><br>The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-<br>traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients<br>whose age, weight, and activity level are compatible with an adequate long-<br>term result; failed osteotomies, unicompartmental replacement, or total knee<br>replacement. Posterior stabilized knee systems are designed for use in<br>patients in primary and revision surgery, where the anterior and posterior<br>cruciate ligaments are absent or incompetent and the collateral ligaments<br>remain intact.<br><br>The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with<br>existing cemented femoral, tibial tray, and patellar components of the<br>Genesis II Total Knee System cleared via K951987 and K953274. The<br>Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use<br>only. | K951987<br>K953274 |
| Genesis II Deep Flexion<br>C/R Insert for use with<br>Genesis II Total Knee<br>System Components in<br>uncemented<br>applications | MBH -<br>Orthopaedics<br>Panel/87 | Knee joint patellofemorotibial<br>metal/polymer porous-coated<br>uncemented prosthesis - Class II | 21 CFR<br>888.3565 | K030612 | Genesis II<br>Deep Flexion<br>C/R Insert for<br>use with<br>Genesis II<br>Total Knee<br>System<br>Components<br>in<br>uncemented<br>applications | The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to<br>be used in conjunction with the components of the Genesis II Total Knee<br>System.<br><br>The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-<br>traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients<br>whose age, weight, and activity level are compatible with an adequate long-<br>term result; failed osteotomies, unicompartmental replacement, or total knee<br>replacement. Posterior stabilized knee systems are designed for use in<br>patients in primary and revision surgery, where the anterior and posterior<br>cruciate ligaments are absent or incompetent and the collateral ligaments<br>remain intact.<br><br>The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with<br>existing cemented patellar and uncemented porous tibial trays and femoral<br>components of the Genesis II Total Knee System cleared via K030612. The<br>Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use<br>only. | 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
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