(21 days)
Not Found
No
The summary describes a knee prosthesis and does not mention any AI or ML components, image processing, or data sets typically associated with AI/ML device development.
Yes
The device is indicated for patients with severe knee pain and disability due to various conditions, aiming to alleviate symptoms and restore function in the knee joint. This aligns with the definition of a therapeutic device designed to treat or manage a disease or condition.
No
The device description clearly states it is a knee prosthesis, which is an implant for treatment, not a diagnostic tool. The "Intended Use" section also describes conditions that lead to its use as a treatment for severe knee pain and disability, not for diagnosis.
No
The device description explicitly states it is a "part of the NexGen system of semiconstrained, nonlinked knee prostheses," which are physical implants. The intended use also describes conditions requiring surgical intervention and implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text describes a knee prosthesis, which is an implantable device used to replace a damaged knee joint. Its intended use is to treat severe knee pain and disability by surgically replacing the joint.
- Lack of Diagnostic Activity: The device itself does not perform any tests on bodily samples to diagnose a condition. It is a therapeutic device used to treat a pre-existing condition.
Therefore, based on the provided information, this device clearly falls outside the definition of an In Vitro Diagnostic.
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.
This device is indicated for cemented use only."
Product codes
JWH
Device Description
The proposed device is part of the NexGen system of semiconstrained, nonlinked 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
Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K072281 lpg1/2)
SEP - 6 2007
Summary of Safety and Effectiveness
| 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 15, 2007 |
| Trade Name: | NexGen ® Prolong ™ All-Poly Patella |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint patellofemorotibial metal/polymer/metal
semiconstrained cemented prosthesis
21 CFR § 888.3560 |
| Predicate Device: | NexGen Knee System, manufactured by Zimmer,
Inc., K933785, cleared January 30, 1995 |
| Device Description: | The proposed device is part of the NexGen system
of semiconstrained, nonlinked 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. - 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 indicated for cemented use only. |
:
1
K072281 (pg 212)
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
Except for a change in material, the NexGen Prolong All-Poly Patella is identical to the predicate device. This modification does not change the intended use or fundamental scientific technology.
Non-Clinical Performance and Conclusions:
Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
SEP - 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. % Mr. Brandon Hipsher, RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw. IN 46581
Re: K072281 Trade/Device Name: NexGen® Prolong™ All-Poly Patella 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 Dated: August 15, 2007 Received: August 16, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Barbere Buchur
Mark N. Me kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
h072281 lpg 1/1)
Indications for Use
510(k) Number (if known):
Device Name:
NexGen® Prolong™ All-Poly Patella
Indications for Use:
- · This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. l
- Collagen disorders and/or avascular necrosis of the femoral condyle. The ।
- 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 indicated for cemented use only.
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)
Aubane Buchs
Division Sign-Off
Division of Ge I. Zestorauve. and Neurological Devices
510(k) Number K072281
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