(78 days)
Not Found
No
The summary describes a knee prosthesis with specific design features for increased flexion and gender-specific anatomy. There is no mention of AI, ML, image processing, or any data-driven algorithms in the intended use, device description, or performance studies.
Yes
The device is a knee prosthesis intended to rehabilitate knees damaged by various joint diseases and deformities, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device described is a knee prosthesis, which is an implant used to replace a damaged knee joint, not to diagnose a condition.
No
The device description clearly indicates that the device is a physical knee prosthesis (femoral components), which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "semiconstrained, nonlinked condylar knee prosthesis." This is a medical implant designed to replace a damaged knee joint.
- Intended Use: The intended use describes the conditions for which the knee prosthesis is indicated (e.g., degenerative joint disease, inflammatory joint disease) and how it is used in surgery (cemented or uncemented). This is a surgical intervention, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or any other activity typically associated with in vitro diagnostics.
Therefore, this device is a medical device (specifically, a knee implant), not an IVD.
N/A
Intended Use / Indications for Use
Gender Solutions "Natural-Knee" Flex System:
- · Components with CST porous coating are indicated for uncemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
- · Components without CSTi are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (ID), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
- · The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong "Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Femoral Component:
- · This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis,
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- · This device is intended for cemented use only.
- · Specific uses with CR-Flex GSF femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The Gender Solutions Natural-Knee Flex (N-K Flex) and NexGen CR-Flex GSF components are semiconstrained, nonlinked condylar knee prosthesis that are designed to have a maximum active flexion of 155 degrees. The GSM and GSF femoral component designations indicate that the design of the femoral components has been modified to address specific anatomical features of the distal femur that can be seen in patients of either gender, but are more typical of male and female patients, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Skeletally mature individuals
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)
Non-Clinical Performance and Conclusions: Mechanical testing of the subject devices demonstrates that they are substantially equivalent to the predicate devices.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices.
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.
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
KO71107 (ps 1 of 3)
Summary of Safety and Effectiveness
JUL - 6 2007
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher, RAC
Senior Associate, Corporate Regulatory Affairs
Telephone: (574) 371-8083
Fax: (574) 372-4605 |
| Date: | April 18, 2007 |
| Trade Name: | Gender Solutions™ Natural-Knee® Flex System;
NexGen® Complete Knee Solution CR-Flex Gender
Solutions Female (GSF) Femoral Component |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint patellofemorotibial
polymer/metal/polymer semiconstrained cemented
prosthesis
21 CFR § 888.3560 |
| | Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis
21 CFR § 888.3565 |
| Predicate Devices: | Gender Solutions Natural-Knee Flex System,
manufactured by Zimmer, Inc., K070214, cleared
March 16, 2007.
NexGen Knee Gender Solutions Female (GSF)
Femoral Components, manufactured by Zimmer,
Inc., K060370, cleared April 28, 2006. |
| Device Description: | The Gender Solutions Natural-Knee Flex (N-K
Flex) and NexGen CR-Flex GSF components are
semiconstrained, nonlinked condylar knee
prosthesis that are designed to have a maximum
active flexion of 155 degrees. The GSM and GSF
femoral component designations indicate that the
design of the femoral components has been
modified to address specific anatomical features of |
:
. .
1
Kc71107 (pg. 2 of 3)
the distal femur that can be seen in patients of either gender, but are more typical of male and female patients, respectively.
Intended Use:
N-K Flex System:
- · Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
- · Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
- · The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal™ CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90prefix 17 or 20mm Prolong " Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
NexGen CR-Flex GSF Femoral Components:
- · This device is indicated for patients with severe knee pain and disability due to:
- -Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- -Collagen disorders, and/or avascular necrosis of the femoral condyle.
- -Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
2
K071107 (pg. 3 of 3)
| | - Moderate valgus, varus, or flexion
deformities.
- The salvage of previously failed surgical
attempts or for a knee in which satisfactory
stability in flexion cannot be obtained at the
time of surgery.
• This device is intended for cemented use only.
• Specific uses with CR-Flex GSF femorals: - Provides increased flexion capability for
patients who have both the flexibility and
desire to increase their flexion range. - The CR-Flex GSF femoral, when used with
90-prefix NexGen CR articular surfaces, 00-
prefix 10, 12 or 14mm or 90-prefix 17 or
20mm Prolong Highly Crosslinked
Polyethylene CR articular surfaces, or with
Gender Solutions™ Natural-Knee® Flex
Congruent articular surfaces, is designed for
use with a functional posterior cruciate
ligament and when load bearing range of
motion (ROM) is expected to be less than or
equal to 155 degrees. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | Except for changes in component compatibility, the
subject components are identical to the predicate
device. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: |
| | Mechanical testing of the subject devices
demonstrates that they are substantially equivalent
to the predicate devices. |
| | Clinical Performance and Conclusions: |
| | Clinical data and conclusions were not needed for
these devices. |
.
. .
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL -6 2007
JUL
Zimmer, Inc. % Mr. Brandon Hipsher, RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K071107
Trade/Device Name: Gender Solutions™ Natural-Knee® Flex System; NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Female (GSF) Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: MBH, JWH Dated: June 1, 2007 Received: June 4, 2007
Dear Mr. Hipsher:
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.
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - Mr. Brandon Hipsher, RAC
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 (240) 276-0120. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours, Mark N. Melkerson Director Division of General, Restorativ and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K071107
Indications for Use
510(k) Number (if known):
Device Name:
Gender Solutions™ Natural-Knee® Flex System; NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Femoral Component
Indications for Use:
Gender Solutions "Natural-Knee" Flex System:
- · Components with CST porous coating are indicated for uncemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
- · Components without CSTi are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (ID), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
- · The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong "Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Femoral Component:
- · This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis,
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
- · This device is intended for cemented use only.
- · Specific uses with CR-Flex GSF femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.
Prescription Use X (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)
| (Division Sign-Off)
Division of General, Restorative,
| and Neurological Devices | Page 1 of 1 |
|---|---|
| -------------------------------------------------------------------------------------- | ------------- |
| 510(k) Number | K071107 |
|---|---|
| --------------- | --------- |