(90 days)
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No
The summary describes a traditional knee implant system and does not mention any AI or ML components, image processing, or performance studies related to algorithmic analysis.
Yes
The device is described as a replacement for knee components and is indicated for conditions like arthritis, aiming to alleviate symptoms and restore function, which aligns with the definition of a therapeutic device.
No
This device is a knee system (tibial baseplate) intended for joint replacement, not for diagnosing conditions.
No
The device description clearly states "Tibial Baseplate, Cast, CorCr/Ti Porous and CoCr Non-Porous," indicating a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing knee joints due to various arthritic conditions or failed previous surgeries. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a "Tibial Baseplate," which is a component of a knee implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVDs are used for diagnosis, monitoring, or screening by analyzing samples taken from the body. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The Consensus® Knee System and the CoCr/Ti porous or CoCr nonporous tibial baseblate is design for use as a system, and is not intended for substitution with components of other systems. This device is intended for cemented use only. The indications for use are:
- Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or 1. degenerative arthritis.
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- Failed osteotomy or unicompartmental replacements.
- Replacement of unsatisfactory cemented or press fit knee components, if sufficient 3. bone stock exists.
Contraindications for use of the device are:
-
- Any active or suspected latent infection in or about the knee joint.
-
- Bone stock compromised by disease, infection, or prior implantation, which cannot provide adequate support and fixation of the prosthesis.
-
- Mental or neuromuscular disorders which would create an unacceptable risk of prosthesis instability or complications in postoperative care.
-
- Conditions that tend to place increased loads on implants such as age, weight and activity level, which are incompatible with a satisfactory clinical long-term result.
Product codes
JWH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
knee joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 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" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 AUG
Mr. William J. Griffin QS&RA Manager Hayes Medical, Inc. 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762
Re: K001456
Trade Name: Tibial Baseplate, Cast, CorCr/Ti Porous and CoCr Non-Porous Regulatory Class: II Product Code: JWH Dated: May 5, 2000 Received: May 9, 2000
Dear Mr. Griffin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
1
Page 2 - Mr. William Griffin
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Donna R. Vochner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 8 Statement of Indications for Use
The Consensus® Knee System and the CoCr/Ti porous or CoCr nonporous tibial baseblate is design for use as a system, and is not intended for substitution with components of other systems. This device is intended for cemented use only. The indications for use are:
- Primary intervention of rheumatoid arthritis, osteoarthritis, post traumatic arthritis or 1. degenerative arthritis.
-
- Failed osteotomy or unicompartmental replacements.
- Replacement of unsatisfactory cemented or press fit knee components, if sufficient 3. bone stock exists.
Contraindications for use of the device are:
-
- Any active or suspected latent infection in or about the knee joint.
-
- Bone stock compromised by disease, infection, or prior implantation, which cannot provide adequate support and fixation of the prosthesis.
-
- Mental or neuromuscular disorders which would create an unacceptable risk of prosthesis instability or complications in postoperative care.
-
- Conditions that tend to place increased loads on implants such as age, weight and activity level, which are incompatible with a satisfactory clinical long-term result.
Dune R. Lochner
(Division S. Division of · Restorative Devices 510(k) Numo: KOO14C