(143 days)
The Global Resurfacing Unicompartmental (GRU) Knee System is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial conclyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant that is intended for use with bone cement.
The Global Resurfacing Unicompartmental Knee System consists of femoral and tibial components. The femoral component is anatomic in design, to provide coverage of the condyle from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right geometries. A central keel and post on the back of the femoral component assists in cement fixation and rotational stability. The device is manufactured from cobalt chrome alloy that conforms to ASTM F-75-01. The tibial component is semi-lunar in configuration and manufactured from compression molded ultra-high molecular weight polyethylene (UHMWPE) that conforms to ASTM F-648-00. The tibial component is universal in geometry.
The provided text is related to a 510(k) premarket notification for a medical device: the Global Resurfacing Unicompartmental Knee System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for a novel technology or AI algorithm.
Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment, as typically found in AI/ML device submissions, is NOT present in this document.
The document primarily covers:
- Device Name: Global Resurfacing Unicompartmental (GRU) Knee System
- Sponsor: Global Orthopaedic Technology USA, Inc.
- Classification Name: Knee Joint, Femorotibial, Metal/Polymer, Semi-constrained, Cemented Prosthesis (21 CFR 888.3530)
- Intended Use: Partial replacement of articulating surfaces of the knee when only one side is affected due to various conditions (degenerative disease, fractures, deformity, revision arthroplasty). Single-use, intended for implantation with bone cement.
- Device Description: Consists of anatomic femoral component (cobalt chrome alloy ASTM F-75-01) and semi-lunar tibial component (UHMWPE ASTM F-648-00).
- Potential Risks: Standard risks associated with joint replacement devices (e.g., reaction to bone cement, loosening, infection, fracture, wear).
- FDA Decision: Substantial equivalence based on the 510(k) submission, allowing the device to be marketed.
In summary, the provided text does not contain the information required to populate the requested table and answer the specific questions related to acceptance criteria and performance studies for an AI/ML device.
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K03351
MAR 1 1 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
- Global Orthopaedic Technology USA, Inc. Sponsor: 5349 Fled Leaf Court Oviedo, Florida 32765
Global Resurfacing Unicompartmental Knee System Device:
Classification Name: Knee Joint, Femorotibial, Metal/Polymer, Semi-constrained, Cemented Prosthesis (21 CFR 888.3530)
Intended Use: Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant intended for implantation with bone cement.
Device Description: The Global Resurfacing Unicompartmental Knee System consists of femoral and tibial components.
The femoral component is anatomic in design, to provide coverage of the condyle from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right geometries. A central keel and post on the back of the femoral component assists in cement fixation and rotational stability. The device is manufactured from cobalt chrome alloy that conforms to ASTM F-75-01.
The tibial component is semi-lunar in configuration and manufactured from compression molded ultra-high molecular weight polyethylene (UHMWPE) that conforms to ASTM F-648-00. The tibial component is universal in geometry.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to bone cernent Deformity of the joint Cardiovascular disorders Fracture of bone cement Implant loosening/migration Nerve damage
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Bone fracture Infection Hematoma Dislocation Excessive wear
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2004
Mr. Carl Knobloch Chief Operating Officer Global Orthopaedic Technology, USA, Inc. 5349 Red Leaf Court Oviedo, Florida 32765
Re: K033351
Trade/Device Name: Global Resurfacing Unicompartmental (GRU) Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: February 16, 2004 Received: February 17, 2004
Dear Mr. Knobloch:
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. Carl Knobloch
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely vours.
Mark N. Millman
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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Confidential
Indications for Use
510(k) Number (if known): K033351
Device Name: Global Resurfacing Unicompartmental (GRU) Knee System
Indications For Use: The Global Resurfacing Unicompartmental (GRU) Knee System is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial conclyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant that is intended for use with bone cement.
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 Do
Mullins
Division of General, Restorative, and Neurological Devices
510(k) Number K033351
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§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.