(169 days)
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No
The summary describes a traditional knee replacement system and contains no mention of AI, ML, or related concepts.
Yes
The device is a total knee replacement system intended for the reconstruction of painful and/or severely disabled knee joints resulting from various arthritic conditions or previously failed prostheses, which are therapeutic interventions.
No
Explanation: The device described is a total knee replacement system, which is a prosthetic device used for reconstruction of knee joints, not for diagnosing medical conditions.
No
The device description clearly identifies it as a "Total Knee Replacement System," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that this is a "Total Knee Replacement System" intended for the "reconstruction of painful and/or severely disabled knee joints." This is a surgical implant used within the body to replace a damaged joint.
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The BUECHEL-PAPPASTM (B-P) Fixed Bearing New Jersey (NJ) Total Knee Replacement System is intended for the reconstruction of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Additionally, it is intended for Subjects with severe arthritis (e.g. Posttraumatic, rheumatoid or osteoarthritis.). with sufficient bone stock (i.e. cortical bone present to support the platform of the components) and ligamentous support (i.e. intact medial and lateral collateral ligaments) to allow stable, anatomical positioning of components and supporting tissue structures, who are skellatly mature and have not responded to conservative treatment (i.e. injections, therapy, etc.). Porous components and textured components are intended for cemented use.
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 joints
Indicated Patient Age Range
Skeletally mature subjects.
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)
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Reference Device(s)
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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.
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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alex Canonaco JAN 3 0 2002 Product Engineer Endotec, Inc. 20 Valley Street South Orange, New Jersey 07079
Re: K012702
Trade/Device Name: Buechel-Pappas (B-P) Fixed Bearing New Jersey Total Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: November 30, 2001 Received: December 3, 2001
Dear Mr. Canonaco:
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 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.
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Page 2 - Mr. Alex Canonaco
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Milken
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
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C. INDICATIONS FOR USE
510(k) Number (if known):_K012702
Device Name: Buechel-Pappas (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE REPLACEMENT SYSTEM
Indications For Use:
The BUECHEL-PAPPASTM (B-P) Fixed Bearing New Jersey (NJ) Total Knee Replacement System is intended for the reconstruction of painful and/or severely disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Additionally, it is intended for Subjects with severe arthritis (e.g. Posttraumatic, rheumatoid or osteoarthritis.). with sufficient bone stock (i.e. cortical bone present to support the platform of the components) and ligamentous support (i.e. intact medial and lateral collateral ligaments) to allow stable, anatomical positioning of components and supporting tissue structures, who are skellatly mature and have not responded to conservative treatment (i.e. injections, therapy, etc.). Porous components and textured components are intended for cemented use.(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
Mask
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number -
Division of General Restorative Devices 510(k) Number OR Prescription Use_
Over-The-Counter Use_
12702