(85 days)
Not Found
No
The device description and intended use focus on mechanical components (augments) for knee replacement systems. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
This device is a medical implant (NexGen Augments used with NexGen Knee Systems) intended to treat severe knee pain and disability caused by various conditions, which aligns with the definition of a therapeutic device.
No
The device description and indications for use clearly show that this device is an implantable augment used in knee replacement surgery, not a tool for diagnosis.
No
The device description clearly states that the device is comprised of "tibial and femoral augments of various shapes and sizes," which are physical components (hardware) used in knee replacement surgery.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to treat knee pain and disability due to various conditions. It is a device implanted within the body.
- Device Description: The description details physical components (augments) that are attached to other knee implant components using bone cement or screws. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For NexGen Augments used with NexGen Knee Systems - Cruciate Retaining (CR), Cruciate Retaining Augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK): 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.
· CR and LPS porous coated femoral and tibial baseplate components may be used cemented biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.
· NexGen Augments that may be used with cemented CR, CRA, PS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.
For NexGen Augments used with NexGen Rotating Hinge Knee System:
This device is indicated for patients with:
- Moderate to severe knee instability.
- Significant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
- Valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts.
This device is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, KRO
Device Description
The NexGen augments are used with the following NexGen Knee Systems:
NexGen Rotating Hinge Knee NexGen Complete Knee Solution:
- · Cruciate Retaining Augmentable (CRA)
- Legacy Constrained Condylar (LCCK)
- · Cruciate Retaining (CR)
- · Posterior Stabilized (PS)
- · Legacy Posterior Stabilized (LPS)
This submission includes tibial and femoral augments of various shapes and sizes. Augments are attached via bone cement or screw to tibial baseplate and femoral components indicated for cemented use only. Use of these augments is optional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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:
Shelf Life Testing:
Accelerated aging testing conducted demonstrated that the subject NexGen augments have a shelf life of 10 years.
Performance Testing:
Non-clinical testing demonstrated that the subject NexGen augments have adequate attachment strength to resist joint reaction forces generated during weight-bearing activities and that PMMA coated titanium substrate to bone cement demonstrated an increased maximum shear load compared to uncoated titanium.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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
§ 888.3560 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be interconnected. The profiles are rendered in a simple, line-art style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
Zimmer, Incorporated Mr. Mark D. Warner Sr. Specialist. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K152494
Trade/Device Name: Zimmer® NexGen® Complete Knee Solution Tibial and Femoral Augments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, KRO Dated: August 31, 2015 Received: September 2, 2015
Dear Mr. Warner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152494
Device Name
Zimmer® NexGen® Complete Knee Solution Tibial and Femoral Augments
Indications for Use (Describe)
For NexGen Augments used with NexGen Knee Systems - Cruciate Retaining (CR), Cruciate Retaining Augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK): 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.
· CR and LPS porous coated femoral and tibial baseplate components may be used cemented biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.
· NexGen Augments that may be used with cemented CR, CRA, PS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.
For NexGen Augments used with NexGen Rotating Hinge Knee System:
This device is indicated for patients with:
-
Moderate to severe knee instability.
-
Significant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.
-
Valgus, varus, or flexion deformities.
-
The salvage of previously failed surgical attempts.
This device is intended for cemented use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image features the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized letter "Z" inside it. Below the circle is the word "zimmer" in lowercase blue letters.
| 510(k) Summary | |
|---|---|
| Sponsor: | Zimmer, Inc. |
| P.O. Box 708 | |
| Warsaw, IN 46581-0708 | |
| Contact Person: | Mark Warner |
| Sr. Specialist, Regulatory Affairs | |
| Telephone: (574) 372-4150 | |
| Fax: (574) 372-4605 | |
| Date: | August 31, 2015 |
| Trade Name: | Zimmer® NexGen® Complete Knee Solution Tibial and |
| Femoral Augments | |
| Common Name: | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, |
| Cemented, Polymer/Metal/Polymer | |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, | |
| Metal/Polymer | |
| Classification Names | |
| and References: | Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis, 21 CFR 888.3560, | |
| JWH | |
| Knee joint femorotibial metal/polymer constrained | |
| cemented prosthesis, 21 CFR 888.3510, KRO | |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | NexGen Complete Knee Solution Cruciate Retaining |
| (Augmentable) and Legacy Constrained Condylar Knee, | |
| manufactured by Zimmer, Inc. (K946150) | |
| NexGen Complete Knee Solution Rotating Hinge Knee, | |
| manufactured by Zimmer, Inc. (K013385) | |
| Purpose and Device | |
| Description: | The NexGen augments are used with the following |
| NexGen Knee Systems: |
4
NexGen Rotating Hinge Knee NexGen Complete Knee Solution:
- · Cruciate Retaining Augmentable (CRA)
- Legacy Constrained Condylar (LCCK)
- · Cruciate Retaining (CR)
- · Posterior Stabilized (PS)
- · Legacy Posterior Stabilized (LPS)
This submission includes tibial and femoral augments of various shapes and sizes. Augments are attached via bone cement or screw to tibial baseplate and femoral components indicated for cemented use only. Use of these augments is optional.
For NexGen augments used with NexGen Knee Systems -Cruciate Retaining (CR), Cruciate Retaining augmentable (CRA), Posterior Stabilized (PS), Legacy Posterior Stabilized (LPS), and Legacy Constrained Condylar Knee (LCCK):
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.
CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.
NexGen augments that may be used with cemented CR, CRA, PS, LPS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.
Intended Use:
5
| | For NexGen augments used with NexGen Rotating Hinge
Knee System: |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | This device is indicated for patients with:
- Moderate to severe knee instability.
- Significant bone loss and/or ligament deficiencies caused
by neoplasms, trauma, rheumatoid arthritis, osteoarthritis,
traumatic arthritis, polyarthritis, collagen disorders,
and/or avascular necrosis of the femoral condyle. - Valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts.
This device is intended for cemented use only. |
| Comparison to Predicate Device: | NexGen tibial and femoral augments were initially cleared
in K946150, K013385. The subject devices include
additional shapes and sizes of the predicate devices. They
have the same intended use, function, and fundamental
technology as the predicate devices. The difference
between the subject and predicate devices do not raise new
issues of safety and effectiveness. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Shelf Life Testing:
Accelerated aging testing conducted demonstrated that the
subject NexGen augments have a shelf life of 10 years. |
| | Performance Testing:
Non-clinical testing demonstrated that the subject NexGen
augments have adequate attachment strength to resist joint
reaction forces generated during weight-bearing activities
and that PMMA coated titanium substrate to bone cement
demonstrated an increased maximum shear load compared
to uncoated titanium. |
| | Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this
device. |