(79 days)
Not Found
No
The document describes a traditional knee replacement system and does not mention any AI or ML components or functionalities.
Yes
The device is a knee replacement system intended for total knee replacement, which is a surgical procedure to alleviate pain and restore function in severe knee conditions, aligning with the definition of a therapeutic device.
No
This device is a total knee replacement system, which is a therapeutic device designed to replace a damaged knee joint, not to diagnose a condition.
No
The device description explicitly states that the system includes physical components such as femoral components, 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:
- 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: The NEO CR Knee System is described as components for total knee replacement, including femoral components, tibial trays, and patellar components. These are implants designed to be surgically placed within the body.
- Intended Use: The intended use is for total knee replacement surgery in skeletally mature individuals with severe knee pain and disability due to various conditions. This is a surgical procedure, not a diagnostic test performed on samples outside the body.
The information clearly indicates that this is a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NEO CR Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact 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, failed partial knee replacement, or failed 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 CR Knee System components are indicated for use only with cement and are single use devices.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The NEO CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial trays, patellar components and surgical instrumentation.
The Neo CR Knee System femoral component, when used with the Neo CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
Mentions image processing
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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 Knee System has been evaluated for tibial tray fatigue strength, insert locking mechanism strength, femorotibial range of motion, femorotibial range of constraint, patellofemoral range of constraint, femorotibial contact areas/contact stress, and patellofemoral contact area and contact stress.
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
K 12.0313 (1/2)
APR 2 0 2012
NEO CR Knee System 510(k) Summary
NEO CR Knee System Device Proprietary Name:
Total Knee System Common Name:
888.3560 Classification regulation:
Device Class: Class II
Product Codes:
JWH (cemented knees)
Submitter's Name: Pipeline Orthopedics 3 Wing Drive, Suite 200, Cedar Knolls, NJ 07927 Address: Robert C. Cohen Contact Person: Telephone Number: (973) 267-8800 (973) 267-8810 Fax Number:
April 17, 2012 Date Summary Prepared:
Device Description:
The NEO CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial trays, patellar components and surgical instrumentation.
The Neo CR Knee System femoral component, when used with the Neo CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
Intended Use
The Neo CR Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact 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, failed partial knee replacement, or failed 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 CR Knee System components are indicated for use only with cement and are single use devices.
1
NEO CR 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 |
|-------------------------------------------------------------------------------------|--------------|----------|-------------------|
| NexGen Complete Knee Solution
Cruciate Retaining (CR)-Flex Femoral
Components | Zimmer | K023211 | 10/17/2002 |
| Gender Solutions Natural-Knee Flex
System | Zimmer | K073286 | 03/07/2008 |
| Triathlon Cruciate Retaining (Cr) Total
Knee System | Stryker | K040267 | 5/5/2004 |
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 CR Knee System to the predicate knee systems and performance testing confirm that the NEO CR 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 Knee System has been evaluated for tibial tray fatigue strength, insert locking mechanism strength, femorotibial range of motion, 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 CR 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 CR Knee System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pipeline Orthopedics, Incorporated % M Squared Associates Ms. Terry Sheridan Powell Consultant 901 King Street, Suite 200 Alexandria, Virginia 22314
Received: February 1, 2012
Re: K120313
Trade/Device Name: NEO CR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: Class II Product Code: JWH Dated: January 30, 2012
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.
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 that I Dr man matures and regulations administered by other Federal agencies. You must or any I vith 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
APR 2 0 2012
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 go to http://www.fda.gov/AboutFD/VCentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
for Datha
Mrs. Linda
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:
To be assigned K120313
NEO CR Knee System Device Name:
The NEO CR Knee System components are indicated for use in Indications for Use: skeletally mature individuals, with severe knee pain and disability, with an intact 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, failed partial knee replacement, or failed 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 CR 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
· Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number: K120313
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