(247 days)
Not Found
No
The device description and intended use clearly describe a physical implant (articular insert) for a total knee system. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies focus on mechanical testing, not algorithmic performance.
No
This device is a component of a total knee replacement system, which is a surgical implant designed to replace diseased or damaged knee joints. It is used to restore function and alleviate pain, rather than for therapeutic treatment in the sense of actively healing or curing a condition.
No
The device is an articular insert for a total knee replacement system, used as a treatment, not for diagnosing a condition.
No
The device description explicitly states that the Genesis II Deep Flexion Cruciate Retaining Articular Inserts are "UHMWPE tibial components," indicating they are physical hardware implants made of Ultra-High Molecular Weight Polyethylene.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Genesis II Deep Flexion Cruciate Retaining Articular Insert is a component of a Total Knee System. It is a physical implant made of UHMWPE (Ultra-high-molecular-weight polyethylene) designed to be surgically implanted into the knee joint.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is mechanical, providing articulation within the knee joint.
Therefore, this device falls under the category of a medical device (specifically, a prosthetic implant), but not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
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.
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)
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.
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, K032295
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
§ 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.
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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
510(k) | Identification
of Device | Indications for Use | Predicate
510(k) |
|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Genesis II Deep Flexion
C/R Insert for use with
Genesis II Total Knee
System Components in
cemented applications | JWH -
Orthopaedics
Panel/87 | Knee joint patellofemorotibial
polymer/metal/polymer semi-
constrained cemented prosthesis -
Class II | 21 CFR
888.3560 | K951987
K953274 | Genesis II
Deep Flexion
C/R Insert for
use with
Genesis II
Total Knee
System
Components
in cemented
applications | 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. | K951987
K953274 |
| Genesis II Deep Flexion
C/R Insert for use with
Genesis II Total Knee
System Components in
uncemented
applications | MBH -
Orthopaedics
Panel/87 | Knee joint patellofemorotibial
metal/polymer porous-coated
uncemented prosthesis - Class II | 21 CFR
888.3565 | K030612 | Genesis II
Deep Flexion
C/R Insert for
use with
Genesis II
Total Knee
System
Components
in
uncemented
applications | 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 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. | 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).
2
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
3
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
4
p. 1/2
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
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