(151 days)
Not Found
No
The document describes a mechanical knee replacement system and its components. There is no mention of software, algorithms, image processing, AI, or ML.
Yes.
The device is indicated for use in individuals with severe knee pain and disability due to various conditions, aiming to alleviate symptoms and restore function through total knee replacement.
No
Explanation: The document describes a total knee replacement system, which is a prosthetic device used for treatment, not for diagnosing medical conditions. The "Intended Use" section lists conditions for which the device is indicated, but the device itself does not perform the diagnosis.
No
The device description explicitly lists hardware components such as femoral components, tibial inserts, tibial trays, patellar components, and surgical instrumentation, indicating it is a physical medical device system, not software-only.
Based on the provided information, 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 and Intended Use: The description clearly states that the Pipeline CR Total Knee System components are used for total knee replacement surgery. This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, diagnostic testing, or the detection of diseases through in vitro methods.
Therefore, the Pipeline CR Total Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing 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 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.
Pipeline CR Total 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 Pipeline Primary CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation.
The Pipeline CR Total Knee System femoral component, when used with the Pipeline CR 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)
Performance testing confirm that the Pipeline Primary CR Knee System is capable of withstanding the anticipated physiological conditions associated with the indications for use.
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
Pipeline Primary CR Knee System 510(k) Summarv - K113122
| Device Proprietary Name: | Pipeline Primary CR Knee System |
|---|---|
| Common Name: | Total Knee System |
| Classification regulation: | 888.3560 (implants/instruments) |
| Device Class: | Class II |
| Product Codes: | JWH (cemented knees) |
| Submitter's Name: | Pipeline Orthopedics |
| Address: | 3 Wing Drive, Suite 200, Cedar Knolls, NJ 07927 |
| Contact Person: | Robert C. Cohen |
| Telephone Number: | (973) 267-8800 |
(973) 267-8810
Date Summary Prepared: February 16, 2012
Device Description:
Fax Number:
The Pipeline Primary CR Knee System includes components designed for total knee The system includes femoral components, tibial inserts, tibial trays, replacement. patellar components and surgical instrumentation.
The Pipeline CR Total Knee System femoral component, when used with the Pipeline CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
Intended Use:
The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing 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 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. ●
Pipeline CR Total Knee System components are indicated for use only with cement and are single use devices.
Page 1 of 2.
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Pipeline Primary CR Knee System 510(k) Summary - K113122
Predicate Devices:
The Pipeline Primary 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 Pipeline Primary CR Knee System to the predicate knee systems and performance testing confirm that the Pipeline Primary 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.
Substantial Equivalence Information:
The Pipeline Primary 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 Pipeline Primary CR Knee System is substantially equivalent to the predicate devices.
Page 2 of 2
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 0 2012
Pipeline Orthopedics, Incorporated % M Squared Associates Ms. Terry Sheridan Powell Consultant 901 King Street, Suite 200 Alexandria, Virginia 22314
Re: K113122
Trade/Device Name: Pipeline Cruciate Retaining (CR) Primary 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: March 16, 2012 Received: March 19, 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. 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
3
Page 2 - Ms. Terry S. Powell
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 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/AboutFDA/CentersOffices/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/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 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
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: K113122
Pipeline Primary CR Knee System Device Name:
Indications for Use: The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing 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 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. .
Pipeline CR 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
(Division Sign-Off)
Division of Surgical. Innopedie, and Kestorative Devices
510(k) Number K113122
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