(172 days)
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.
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.
The document is a 510(k) summary for the Pipeline Knee System, which is a knee joint prosthesis. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria for device performance.
Therefore, the provided text does not contain acceptance criteria for device performance in the way one would expect for a diagnostic or AI-driven decision support system (e.g., sensitivity, specificity, accuracy thresholds). Similarly, it doesn't describe a study that "proves" the device meets such criteria through statistical analysis of clinical outcomes.
Instead, the document details non-clinical performance testing to support the substantial equivalence of the new Pipeline Knee System to existing predicate devices.
Given this context, I will address the requested information based on what is available in the provided text, while also noting what is not present due to the nature of this type of submission.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Proxy) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Mechanical Performance: Ability to withstand anticipated physiologic loading. (Implicit within the submission's goal of demonstrating substantial equivalence to legally marketed devices for the same indications for use and material/design characteristics.) | 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 - Patellofemoral contact area and contact stress - Wear simulation. |
| Material Properties: Highly crosslinked Vitamin E polyethylene material properties are comparable to legally marketed devices, ensuring safety and performance. (Implicit within the submission's goal of demonstrating substantial equivalence to legally marketed devices for the same indications for use and material/design characteristics.) | Testing provided to support the substantial equivalence of the highly cross-linked Vitamin E polyethylene for the following properties: - 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 - Biocompatibility testing. |
| Indications for Use: The device is suitable for the stated indications and is comparable to predicate devices in this regard. | The Pipeline Knee System's indications for use are similar to legally marketed predicate devices, for skeletally mature patients with severe knee pain and disability due to various conditions (e.g., rheumatoid arthritis, osteoarthritis, traumatic arthritis, collagen disorders, avascular necrosis, post-traumatic loss of joint configuration, deformities, salvage of failed attempts). |
Additional Requested Information:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes non-clinical performance testing of a physical medical device (knee prosthesis), not a software device or AI algorithm with a 'test set' of data. The testing involves mechanical and material property assessments on device components or prototypes. There is no mention of patient data or clinical data utilized as a 'test set'.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As this is non-clinical testing of a physical device, there is no 'ground truth' established by medical experts in the context of imaging or clinical diagnoses. The "truth" for mechanical and material properties is determined by engineering standards and measurement techniques.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. There is no 'test set' or adjudication process involving human experts for establishing ground truth in this non-clinical testing context.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a 510(k) submission for a physical knee prosthesis, not an AI or imaging diagnostic device. Therefore, no MRMC study or AI-assisted performance evaluation was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This filing pertains to a physical orthopedic implant. There is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the non-clinical performance data, the 'ground truth' is based on established engineering and material science principles, standardized test methods (likely ASTM or ISO standards), and physical measurements of the device's mechanical and material properties. It is not an expert consensus on clinical cases, pathology, or outcomes data, as these are not relevant for demonstrating substantial equivalence of a device's physical and material characteristics.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI algorithm; therefore, there is no concept of a 'training set'.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not applicable.
{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 Orthopedics3 Wing Drive, Suite 102, Cedar Knolls, NJ 07927Robert 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) TotalKnee Systems | Wright MedicalTechnology | 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 SystemECIMA Liners | Corin USA | K111481 |
| Vanguard Patellar Components | Biomet | K040770 |
| iTotal Cruciate Retaining KneeReplacement System with iPoly XETibial Inserts and Patellae | ConforMIS Inc. | K122870 |
| Natural Knee II Durasul Tibial Insertand 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
§ 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.