(260 days)
No
The document describes a standard knee replacement system with mechanical components and does not mention any AI/ML capabilities or data processing related to AI/ML.
Yes
The device is a total knee replacement system, which medically treats severe knee pain and disability, thereby serving a therapeutic purpose.
Question: Is this device a diagnostic device?
No
The provided text describes a total knee replacement system used for surgical intervention, not for diagnosing medical conditions. Its intended use is to replace knee components for individuals with severe knee pain and disability due to various arthritic conditions or failed prior surgeries.
No
The device description clearly states it includes physical components for total knee replacement (femoral components, tibial inserts, tibial trays, patellar components, and surgical instrumentation), which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total knee replacement. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device components are physical implants (femoral components, tibial inserts, etc.) designed to replace parts of the knee joint. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory analysis.
Therefore, the NEO™ PS Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NEO™ PS Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with excised posterior cruciate ligament, undergoing surgery for total knee replacement due to:
- . Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
- . Failed osteotomies, partial knee replacement, or failed prior total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
- . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- . Moderate valgus, varus, or flexion deformities.
NEO™ PS Total Knee System components are indicated for use only with cement and are single use devices.
Product codes
JWH
Device Description
The NEO PS Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation: The Neo PS Knee System femoral component, when used with the Neo PS articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
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)
The NEO PS Knee System has been evaluated for tibial tray fatigue strength, insert locking mechanism strength, femorotibial range of motion, PS post strength, femorotibial range of constraint, patellofemoral range of constraint, femorotibial contact areas/contact stress, and patellofemoral contact area and contact stress. All evaluations determined that the NEO PS Knee System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120313, K072619, K042271, K991581, K031729
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.
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K122500 (Page 1 of 2)
NEO PS Knee System 510(k) Summary
MAY 0 3 2013
| Device Proprietary Name: | NEO PS Knee System |
|---|---|
| Common Name: | Total Knee System |
| Classification regulation: | 888.3560 |
| Device Class: | Class II |
| Product Codes: | JWH (cemented knees) |
| Submitter's Name: | |
| Address: | |
| Contact Person: | |
| Telephone Number: | |
| Fax Number: | Pipeline Orthopedics |
| 3 Wing Drive, Suite 200, Cedar Knolls, NJ 07927 | |
| Robert C. Cohen | |
| (973) 267-8800 | |
| (973) 267-8810 |
Date Summary Prepared: August 6, 2012
Device Description:
The NEO PS Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation:
The Neo PS Knee System femoral component, when used with the Neo PS articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
Intended Use
The NEO™ PS Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with excised posterior cruciate ligament, undergoing surgery for total knee replacement due to:
- . Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
- . Failed osteotomies, partial knee replacement, or failed prior total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
- . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- . Moderate valgus, varus, or flexion deformities.
NEO™ PS Total Knee System components are indicated for use only with cement and are single use devices.
1
NEO PS Knee System 510(k) Summary
Predicate Devices:
The NEO CR Knee System is similar to several predicates including the following.
| Trade/Proprietary Name | Manufacturer | 510(K) # | Clearance Date |
|---|---|---|---|
| NEO CR Knee System | Pipeline | K120313 | 4/20/2012 |
| NexGen® LPS-Flex Knee System | Zimmer | K072619 | 11/21/2007 |
| K042271 | 10/13/2004 | ||
| K991581 | 07/30/1999 | ||
| Triathlon PS Knee System | Stryker | K031729 | 9/2/2003 |
Technological Characteristics:
The metals and standard UHMWPE material from which the components are manufactured are the same materials used in the predicate knee systems and comply with applicable implantable materials standards. A comparison of design features of the NEO PS Knee System to the predicate knee systems and performance testing confirm that the NEO PS Knee System is capable of withstanding the anticipated physiological conditions associated with the indications for use and is substantially equivalent to the predicate devices.
Performance Testing:
The NEO PS Knee System has been evaluated for tibial tray fatigue strength, insert locking mechanism strength, femorotibial range of motion, PS post strength, femorotibial range of constraint, patellofemoral range of constraint, femorotibial contact areas/contact stress, and patellofemoral contact area and contact stress.
Substantial Equivalence Information:
The NEO PS Knee System is similar to legally marketed devices listed previously in that they share similar indications for use and incorporate similar technological characteristics. All evaluations determined that the NEO PS Knee System is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 swooping lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
Pipeline Orthopedics % M Squared Associates, Incorporated Ms. Terry Sheridan Powell 901 King Street, Suite 102 Alexandria, Virginia 22314
Re: K122500
Trade/Device Name: NEO PS Knee System 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: April 24, 2013 Received: April 25, 2013
Dear Ms. Powell:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Terry Sheridan Powell
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K122500
Indications for Use Statement
510(k) Number: To be assigned
Device Name: NEO PS Knee System
Indications for Use:
The NEO™ PS Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with excised posterior cruciate ligament, undergoing surgery for total knee replacement due to:
- . Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
- . Failed osteotomies, partial knee replacement, or failed prior total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
- . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities. .
NEO™ PS Total Knee System components are indicated for use only with cement and are single use devices.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet际比:Frank -S
Division of Orthopedic Devices
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