(143 days)
The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, 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. .
The Neo Total Knee System components are indicated for use only with cement and are single use devices.
The NEO Total Knee System was cleared for marketing in April 2012, under 510(k) #K120313. The predicate knee system includes a cruciate retaining (CR) femoral component design, tibial trays, CR tibial inserts for use with intact posterior cruciate ligament(PCL), and patellar components. The subject 510(k) adds ultra congruent (UC) tibial inserts for use when the PCL is sacrificed. There are no changes to materials or to system component size offering.
The Neo Knee System CR femoral components, when used with the mating Neo Knee System CR and UC articular surfaces, are designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
The provided document is a 510(k) summary for the NEO Total Knee System - Line Extension. This document does not describe a study involving an AI/CADeX device. Instead, it describes a medical device (a knee implant) and its performance through mechanical and material testing, not a clinical or comparative effectiveness study involving human readers or AI.
Therefore, many of the requested categories in the prompt do not apply to this document. I will answer the questions that can be addressed based on the provided text, and explicitly state when a question is not applicable.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to legally marketed predicate devices. This is achieved by showing that the new components (ultra congruent tibial inserts) perform comparably to or within acceptable limits for a total knee replacement system. The performance criteria are related to the mechanical and material integrity of the implant components.
| Acceptance Criteria (Implicit from Performance Testing) | Reported Device Performance |
|---|---|
| Material Compliance: Materials used are safe and comply with applicable implantable materials standards. | The metal and the standard UHMWPE material are the same as used in the predicate Neo Total Knee System and comply with applicable implantable materials standards. |
| Mechanical Strength & Durability (Fatigue, Locking Mechanism): Tibial tray fatigue strength and insert locking mechanism strength are adequate for in vivo loading. | New testing submitted in this 510(k) or previously submitted in K120313 evaluated tibial tray fatigue strength and insert locking mechanism strength. The testing confirms the system is capable of withstanding expected in vivo loading. |
| Femorotibial & Patellofemoral Kinematics/Constraint: Appropriate range of motion and constraint for femorotibial and patellofemoral joints. | Testing evaluated femorotibial range of motion, femorotibial range of constraint, and patellofemoral range of constraint. The Neo Knee System CR femoral components, used with mating CR and UC articular surfaces, are designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees. |
| Contact Mechanics (Area/Stress): Femorotibial and patellofemoral contact areas and stresses are within acceptable limits. | Testing evaluated femorotibial contact areas/contact stress and patellofemoral contact area and contact stress. The testing confirms the system is capable of withstanding expected in vivo loading. |
| UHMWPE Characterization: The UHMWPE material properties are appropriate. | Characterization of the UHMWPE was performed. The testing confirms the system is capable of withstanding expected in vivo loading. |
| Substantial Equivalence: Overall device is substantially equivalent to predicate devices based on design, materials, and performance. | The NEO Total Knee System is considered substantially equivalent to the predicate devices due to sharing the same indications for use, materials, manufacturing methods, and similar design, technological, and performance characteristics as the predicate Neo CR Knee System and other cited predicate devices. |
Study Proving Device Meets Acceptance Criteria:
The study referenced is a series of "Performance Testing" and a comparison of "Technological Characteristics" to predicate devices. This is a non-clinical, benchtop, and analytical comparison study as typically used for 510(k) submissions for medical devices like implants.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the document. For benchtop mechanical testing, typical sample sizes might be N=5 or N=10 per test condition, but this is not mentioned.
- Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted lab. The terms "retrospective" or "prospectively" do not apply to this type of mechanical testing.
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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. This submission describes the mechanical and material performance of an orthopedic implant, not a diagnostic device that requires expert interpretation for a ground truth. The "ground truth" here is the physical measurement of performance against established standards or predicate device performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As above, this does not involve human interpretation or adjudication for a diagnostic task.
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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. No MRMC or AI study was performed. This is a 510(k) for a physical implant, not an AI/CADeX device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No algorithm or AI device is described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this type of device is based on engineering and material science principles, established mechanical testing standards (e.g., ISO or ASTM for implants), and performance data from legally marketed predicate devices. The goal is to demonstrate that the new component (UC tibial inserts) performs equivalently or acceptably within the established parameters for total knee systems.
-
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned, this question does not apply.
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NEO Total Knee System - Line Extension 510(k) Summary
| Device Proprietary Name: | NEO Total Knee System |
|---|---|
| Common Name: | Artificial Total Knee System |
| Classification regulation: | 888.3560 - Knee joint patellofemorotibialpolymer/metal/polymer semi-constrainedcemented prosthesis |
| Device Class: | Class II |
| Product Codes: | JWH (cemented knees) |
| Submitter's Name: | Pipeline Orthopedics |
| Address: | 3 Wing Drive, Suite 102Cedar Knolls, NJ 07927 |
| Contact Person: | Robert C. Cohen |
| Telephone Number: | (973) 267-8800 |
| Fax Number: | (973) 267-8810 |
| Date Summary Prepared: | May 10, 2013 |
Device Description:
The NEO Total Knee System was cleared for marketing in April 2012, under 510(k) #K120313. The predicate knee system includes a cruciate retaining (CR) femoral component design, tibial trays, CR tibial inserts for use with intact posterior cruciate ligament(PCL), and patellar components. The subject 510(k) adds ultra congruent (UC) tibial inserts for use when the PCL is sacrificed. There are no changes to materials or to system component size offering.
The Neo Knee System CR femoral components, when used with the mating Neo Knee System CR and UC articular surfaces, are designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.
Intended Use
The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, 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.
Exhibit 6: Page 1 of 3
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- Post-traumatic loss of joint configuration, particularly when there is ● patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities. o
The Neo Total Knee System components are indicated for use only with cement and are single use devices.
Predicate Devices:
The NEO Total Knee System is similar to several predicates including the following.
| Trade/Proprietary Name | Manufacturer | 510(K) # | Clearance Date |
|---|---|---|---|
| Neo CR Total Knee | Pipeline Orthopedics | K120313 | 04/20/2012 |
| Triathlon Knee System, CS (condylarstabilizing) tibial inserts | Stryker Orthopaedics(Stryker HowmedicaOsteonics) | K063423 | 01/22/2007 |
| Journey II Deep Dished ArticularInserts | Smith & NephewOrthopaedics | K113482 | 02/27/2012 |
Purpose of Submission:
The 510(k) submission includes a line extension that adds ultra congruent (UC) tibial inserts to the predicate Neo Total Knee System.
Technological Characteristics:
The metal and the standard UHMWPE material from which the components are manufactured are the same materials used in the predicate Neo Total Knee System and comply with applicable implantable materials standards. A comparison of design features of the subject to the predicate knee systems and performance testing confirm that the subject NEO Total 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 Total Knee System has been evaluated, either by new testing submitted in this 510(k) or by testing previously submitted in predicate 510(k) #K120313, 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, and characterization of the UHMWPE. The testing confirms that the NEO Total Knee System, including the subject UC inserts and the compatible predicate femoral components, tibial trays, and patellar components (510(k) #K120313), is capable of withstanding
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NEO Total Knee System - Line Extension 510(k) Summary
expected in vivo loading and is substantially equivalent to.competitive legally marketed knee systems.
Conclusions:
The NEO Total Knee System shares the same indications for use and materials and manufacturing methods as the predicate Neo CR Knee System, and is similar in design and technological and performance characteristics to one or more of the cited predicate devices. The NEO Total Knee System is therefore substantially equivalent to the predicate devices.
Exhibit 6: Page 3 of 3
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2013
Pipeline Orthopedics % Ms. Terry Powell M Squared Associates, Incorporated 901 King Street Suite 102 Alexandria, Virginia 22314
Re: K131368
Trade/Device Name: NEO Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 13, 2013 Received: August 14, 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
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Page 2 - Ms. Terry 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 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/Safetv/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/ResourcesforYou/Industrv/default.htm.
Sincerely vours.
Image /page/4/Picture/7 description: The image shows the name "Erin Keith" in a bold, sans-serif font. The letters appear to be slightly distressed or textured, giving them a worn or vintage look. The name is presented in a straightforward manner, with each letter clearly legible despite the textured effect.
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: To-be assigned-K131368
Device Name: NEO Total Knee System
Indications for Use:
The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, 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. .
The Neo Total Knee System components are indicated for use only with cement and are single use devices.
Prescription Use _ X _________________________________________________________________________________________________________________________________________________________ (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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey/L.Hanley,Ph.D
Division of Orthopedic Devices
Page 1 of __ 1__
§ 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.