(30 days)
Not Found
No
The summary describes a mechanical knee prosthesis and explicitly states that AI, DNN, or ML were not found in the description.
Yes
The device is a knee prosthesis, which is used to treat severe knee pain and disability, thus providing a therapeutic benefit for patients.
No
The provided text describes a knee prosthesis (a medical implant), which is a treatment device, not a diagnostic one. Its intended use is to address severe knee pain and disability stemming from various conditions, rather than to identify or characterize those conditions.
No
The device description explicitly states it is a "Tibial Tray," which is a physical implant component of a knee prosthesis, not software.
No, 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 provided text describes a surgical implant (a knee prosthesis) that is physically placed within the patient's body to replace a damaged joint.
- Intended Use: The intended use clearly states it's for treating severe knee pain and disability due to various conditions, which is achieved through surgical implantation, not through testing bodily samples.
The information provided is consistent with a medical device intended for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
NexGen TM Tibial Trays may be used with or without bone cement (biological fixation).
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The NexGen Trabecular Metal (TM) Tibial Tray is part of the Zimmer NexGen family of semiconstrained, nonlinked condylar knee prostheses.
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
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 device demonstrated that it is substantially equivalent to the predicate device.
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
§ 888.3565 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
K072160
Summary of Safety and Effectiveness
SEP - 5 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: | August 3, 2007 |
| Trade Name: | NexGen ® Trabecular Metal™ Tibial Tray |
| 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 Device: | NexGen Porous, Uncemented Tibial Baseplates,
manufactured by Zimmer, Inc., K031061, cleared
October 9, 2003. |
| Device Description: | The NexGen Trabecular Metal (TM) Tibial Tray is
part of the Zimmer NexGen family of
semiconstrained, nonlinked condylar knee
prostheses. |
| Intended Use: | 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 |
1
| - 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. | |
| NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). | |
| Comparison to Predicate Device: | Except for minor modifications, the NexGen TM Tibial Tray is identical to the predicate device. The modifications do not change the intended use or the fundamental scientific technology. |
| Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Mechanical testing of the subject device demonstrated that it is substantially equivalent to the predicate device. | |
| Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
. . . . .
:
"
and the comments of the comments of the comments of the comments of
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2007
Zimmer, Inc. % Mr. Brandon Hipsher, RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, IN 46581
Re: K072160 Trade/Device Name: NexGen® Trabecular Metal™ Tibial Tray Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial/metal/metal constrained cemented prothesis Regulatory Class: II Product Code: MBH, JWH Dated: August 31, 2007 Received: September 5, 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, 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 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.
3
Page 2 - Mr. Brandon Hipsher, RAC
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/dsma/dsmamain.html
Sincerely yours,
Harbara Buenn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Trabecular Metal™ Tibial Tray
Indications for Use:
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.
NexGen TM Tibial Trays may be used with or without bone cement (biological fixation).
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)
Barbara Bourin
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K072160