(172 days)
Not Found
No
The description focuses on the mechanical components and materials of a knee joint prosthesis, with no mention of AI or ML capabilities.
Yes
The Pipeline Knee System is a knee joint prosthesis used to alleviate severe knee pain and disability stemming from various conditions, which aligns with the definition of a therapeutic device designed to treat or manage a disease or condition.
No
The Pipeline Knee System is a knee joint prosthesis intended for treatment of severe knee pain and disability, not for diagnosing a condition.
No
The device description clearly states that the Pipeline Knee System is a "patellofemorotibial polymer/metal/polymer semiconstrained cemented knee joint prosthesis" and includes physical components like "femoral components, tibial trays, biomimetic cruciate retaining (CR) tibial inserts, patellar components, and associated instrumentation." This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Pipeline Knee System is a prosthetic implant designed to replace a damaged knee joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to alleviate pain and disability in patients with severe knee conditions by replacing the joint. This is a therapeutic intervention, not a diagnostic one.
The provided information clearly describes a surgical implant used for treatment, not a device used to test samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Pipeline Knee System is indicated for skeletally mature 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 otherwise be obtained at the time of surgery.
Pipeline 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 Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained cemented knee joint prosthesis. The system includes femoral components, tibial trays, biomimetic cruciate retaining (CR) tibial inserts, patellar components, and associated instrumentation. The tibial trays are manufactured from highly crosslinked vitamin E polyethylene. The patellar components are manufactured from vitamin E polyethylene. The CR inserts are designed for use when the posterior cruciate ligament is intact.
The Pipeline Total Knee System femoral component, when used with the Pipeline Knee System 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 patients
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 Pipeline Knee System has been evaluated through non-clinical performance testing 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, and wear simulation. In addition, testing of the following properties was provided to support the substantial equivalence of the highly-crosslinked Vitamin E polyethylene: tensile strength, yield strength, elongation, density, crystallinity, wear resistance and particle size characterization, free radical concentration, thermal properties, impact strength, small punch strength, oxidation resistance, trans vinylene index, and biocompatibility testing.
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.
K113122, K040267, K093552, K121443, K113482, K111711, K113369, K111481, K040770, K122870, K000235
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 Knee System 510(k) Summary: K123692
MAY 2 4 2013
| Device Proprietary Name: | Pipeline 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 102, Cedar Knolls, NJ 07927 | ||
| Robert C. Cohen | ||
| (973) 267-8800 | ||
| (973) 267-8810 |
Date Summary Prepared: May 23, 2013
Device Description
The Pipeline Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained cemented knee joint prosthesis. The system includes femoral components, tibial trays, biomimetic cruciate retaining (CR) tibial inserts, patellar components, and associated instrumentation. The tibial trays are manufactured from highly crosslinked vitamin E polyethylene. The patellar components are manufactured from vitamin E polyethylene. The CR inserts are designed for use when the posterior cruciate ligament is intact.
The Pipeline Total Knee System femoral component, when used with the Pipeline Knee System articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
Purpose of Submission:
The Pipeline Knee System subject of this 510(k) represents an evolution of the component designs and a line extension to the original Pipeline Knee System cleared by the FDA on March 20, 2012 via 510(k) #K113122.
Intended Use:
The Pipeline Knee System is indicated for skeletally mature 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 .
1
Pipeline Knee System 510(k) Summary: K123692
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 otherwise be obtained at the time of surgery.
Pipeline Knee System components are indicated for use only with cement, and are single use devices.
| Trade/Proprietary Name | Manufacturer | 510(K) # |
|---|---|---|
| Pipeline CR Total Knee System | Pipeline | K113122 |
| Triathlon Knee Systems | Stryker | K040267 |
| Evolution MP (medial pivot) Total | ||
| Knee Systems | Wright Medical | |
| Technology | K093552 | |
| Journey II Knee System: | ||
| CR Knee System, | ||
| Deep Dished Articular Insert, | ||
| BCS Knee System | Smith & Nephew | K121443 |
| K113482 | ||
| K111711 | ||
| Persona Personalized Knee (CR, UC, | ||
| PS Inserts) | Zimmer | K113369 |
| Corin Trinity Acetabular System | ||
| ECIMA Liners | Corin USA | K111481 |
| Vanguard Patellar Components | Biomet | K040770 |
| iTotal Cruciate Retaining Knee | ||
| Replacement System with iPoly XE | ||
| Tibial Inserts and Patellae | ConforMIS Inc. | K122870 |
| Natural Knee II Durasul Tibial Insert | ||
| and Patella | Sulzer Orthopedics | K000235 |
Predicate Devices:
Technological Characteristics/Substantial Equivalence:
The Pipeline Knee System is similar to legally marketed devices listed previously in that they share the same indications for use, are manufactured from the same or similar materials, incorporate similar design/technological characteristics, and have performance characteristics adequate to withstand anticipated physiologic loading,
Performance Data
The Pipeline Knee System has been evaluated through non-clinical performance testing 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
2
Pipeline Knee System 510(k) Summary: K123692
stress, and wear simulation. In addition, testing of the following properties was provided to support the substantial equivalence of the highly-crosslinked Vitamin E polyethylene: tensile strength, yield strength, elongation, density, crystallinity, wear resistance and particle size characterization, free radical concentration, thermal properties, impact strength, small punch strength, oxidation resistance, trans vinylene index, and biocompatibility testing.
3
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human figures or abstract shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2013
Pipeline Orthopedics, LLC % M Squared Associates, Incorporated Ms. Terry Sheridan Powell 901 King Street, Suite 102 Alexandria, Virginia 22314
Re: K123692
Trade/Device Name: Pipeline Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: April 22, 2013 Received: April 23, 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. Iisting 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
4
Page 2 - Ms. Terry Sheridan Powell
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 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/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.
Image /page/4/Picture/7 description: The image shows the name "Erin L. Keith" in a stylized font. The name is written in black ink and appears to be a logo or signature. The letters are bold and have a unique design, making the name stand out.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Tote assigned - K123692 510(k) Number:
Device Name: Pipeline Knee System
Indications for Use: The Pipeline Knee System is indicated for skeletally mature 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 otherwise be obtained at the time of surgery..
Pipeline Knee System components are indicated for use only with cement, and are single use devices.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)
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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices