(70 days)
This device is indicated for 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 be obtained at the time of surgery.
This device is indicated for use when the posterior cruciate ligament is absent or deficient.
This device is intended for use as part of a cemented or uncemented knee prosthesis.
This device is part of the NexGen system of semiconstrained, nonlinked condylar knee prostheses.
The provided text is for a 510(k) premarket notification for a medical device, the "NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a new, extensive clinical trial to establish novel acceptance criteria and performance against those criteria.
Therefore, the document does not contain the acceptance criteria or a study designed to prove the device meets specific performance acceptance criteria in the typical sense of a clinical or analytical validation study for a new technology with novel performance claims.
Instead, the document states:
- Non-Clinical Performance and Conclusions: "Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device."
- Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."
This indicates that the device's acceptance was based on demonstrating equivalence to a previously cleared predicate device (Prolong™ Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component, K013991) through non-clinical testing, rather than establishing new, independent performance metrics. The implicit "acceptance criteria" here are that the new device performs equivalently to the predicate device in relevant non-clinical tests.
Since a typical performance study with defined acceptance criteria and detailed results is not present, I cannot fill out the requested table or answer the specific questions about sample size, ground truth, expert qualifications, etc., as that information is not in the provided text.
In summary, based on the provided text:
- Acceptance Criteria/Reported Device Performance: Not explicitly stated as new criteria. The device's safety and effectiveness were demonstrated by meeting "performance requirements" in non-clinical testing and being "as safe and effective as the predicate device."
- Sample size used for the test set and the data provenance: Not applicable/not provided. No clinical test set data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
- Adjudication method for the test set: Not applicable/not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. Clinical data was explicitly stated as "not needed."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical knee prosthesis, not an AI algorithm.
- The type of ground truth used: Not applicable/not provided. The comparison was to a predicate device based on non-clinical testing.
- The sample size for the training set: Not applicable/not provided. No training set is mentioned as this is not an AI device.
- How the ground truth for the training set was established: Not applicable/not provided.
The key takeaway is that for this 510(k) submission, the "study" proving the device met "acceptance criteria" was non-clinical testing demonstrating equivalence to a predicate device, as opposed to a novel performance study against new, predefined clinical metrics.
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Summary of Safety and Effectiveness
| Submitter: | MAY 26 2006Zimmer, Inc.P.O. Box 708 |
|---|---|
| Warsaw, IN 46581-0708 | |
| Contact Person: | Brandon HipsherAssociate, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | March 16, 2006 |
| Trade Name: | NexGen ® Complete Knee Solution Ultracongruent(UC-Flex) Fixed Bearing Articular SurfaceComponent |
| Common Name: | Total Knee Prosthesis |
| Classification Nameand Reference: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis21 CFR § 888.3560 |
| Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis21 CFR § 888.3565 | |
| Predicate Device: | Prolong ™ Highly Crosslinked PolyethyleneCruciate Retaining (CR) Articular SurfaceComponent, manufactured by Zimmer, Inc.,K013991, cleared December 27, 2001 |
| Device Description: | This device is part of the NexGen system ofsemiconstrained, nonlinked condylar kneeprostheses. |
| Intended Use: | This device is indicated for patients with severeknee pain and disability due to:- Rheumatoid arthritis, osteoarthritis, traumaticarthritis, polyarthritis.- Collagen disorders and/or avascular necrosis ofthe femoral condyle.- Post-traumatic loss of joint configuration |
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particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus or flexion deformities. ﮯ
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is indicated for use when the posterior cruciate ligament is absent or deficient. This device is intended for use as part of a cemented or uncemented knee prosthesis.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
The proposed device is manufactured, packaged and sterilized using the same materials and processes as the predicate device.
Non-Clinical Performance and Conclusions:
Non-clinical testing demonstrated that this device met performance requirements and is as safe and effective as the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2006
Zimmer, Inc. % Mr. Brandon Hipsher, RAC Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K060722
Trade/Device Name: NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH, MBH
Dated: March 16, 2006 Received: March 17, 2006
Dear Mr. Hipsher:
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 such 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); good manufacturing practice requirements as set
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Page 2 - Mr. Brandon Hipsher
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Lerner us
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO607222
Device Name:
NexGen® Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component
Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. l
- 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 be obtained at the time of surgery.
This device is indicated for use when the posterior cruciate ligament is absent or deficient.
This device is intended for use as part of a cemented or uncemented knee prosthesis.
Prescription Use X (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)
Helene Lehner
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K060722
002
§ 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.