(259 days)
No
The 510(k) summary describes a mechanical knee implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat medical conditions such as osteoarthritis, rheumatoid arthritis, and traumatic arthritis, and to correct deformities or revise failed procedures, which are all therapeutic purposes.
No
The device is a knee replacement system intended for surgical implantation, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (femoral component, tibial component, patella button, stems, augments, pegs) which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing or revising a knee joint due to various conditions like arthritis, failed previous surgeries, or deformities. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a knee replacement system (femoral component, tibial component, patella button, stems, augments). This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body for treatment.
N/A
Intended Use / Indications for Use
- Osteoarthritis, rheumatoid arthritis or traumatic arthritis
- Failure of a previously failed joint replacement procedure
- Correction of varus, valgus or post-traumatic deformity
- Correction or revision of unsuccessful osteotomy or arthrodesis
The device is intended for use with bone cement (USA)
Product codes
JWH
Device Description
The AGC V2 Revision Knee System is an extension of Biomet's knee families. Specifically, the devices are similar to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The device consists of a femoral component with modular stems that articulates with a one-piece tibial component. The AGC V2 system employs Biomet's standard all polyethylene patella button.
Unique features of the AGC V2 System included the femoral stem angle being built into the stem itself rather than the boss of the femoral component like other systems. The device expands Biomet's existing AGC product line by providing a device with more constraint than current components and additional augments for the femoral component.
The AGC V2 tibial component provides a one-piece molded component with a high post posterior stabilized option. Pegs on the bottom of the tray provide stability for the augmentations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/2 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a stylized font. Below the logo, the words "Corporate Headquarters" are written in a smaller font.
Summary of Safety and Effectiveness
Biomet. Inc. Sponsor: Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Device: AGC V2 Revision Knee System
Classification Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis (CFR 888.3560)
Indications:
- Osteoarthritis, rheumatoid arthritis or traumatic arthritis 1.
-
- Failure of a previously failed joint replacement procedure
-
- Correction of varus, valgus or post-traumatic deformity
-
- Correction or revision of unsuccessful osteotomy or arthrodesis
The device is intended for use with bone cement (USA)
Device Description: The AGC V2 Revision Knee System is an extension of Biomet's knee families. Specifically, the devices are similar to the AGC Primary Knee cleared through 510(k) K833921, the AGC Revision (posterior stabilized) Knee cleared through 510(k) K912245 and Maxim Knee System cleared through K915132. The device consists of a femoral component with modular stems that articulates with a one-piece tibial component. The AGC V2 system employs Biomet's standard all polyethylene patella button.
Unique features of the AGC V2 System included the femoral stem angle being built into the stem itself rather than the boss of the femoral component like other systems. The device expands Biomet's existing AGC product line by providing a device with more constraint than current components and additional augments for the femoral component.
The AGC V2 tibial component provides a one-piece molded component with a high post posterior stabilized option. Pegs on the bottom of the tray provide stability for the augmentations.
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 the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Nerve damage
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Disassociation of components Bone fracture Infection Hematoma Dislocation Excessive wear
Substantial Equivalence: In function and overall design, Biomet's AGC V2 Revision Knee System is equivalent to almost all knee components on the market. These systems include:
AGC 2000 Total Knee Prosthesis (Biomet, Inc., Warsaw, IN) AGC Revision Knee Prosthesis (Biomet, Inc., Warsaw, IN) MCK (Maxim) Knee System (Biomet, Inc., Warsaw, IN)
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
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SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
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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 features a stylized eagle or bird design with three curved lines representing its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet INC Airport Industry Park P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K984054
Trade Name: AGC V2 Revision Knee System Regulatory Class: II Product Code: JWH Dated: May 6, 1999 Received: May 7, 1999
Dear Ms. Sandborn Beres:
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.
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Page 2 - Ms. Patricia Sandborn Beres
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.
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K984054
Device Name: AGC V2 Revision Knee System
Indications For Use:
- Osteoarthritis, rheumatoid arthritis or traumatic arthritis 1.
- Failure of a previously failed joint replacement procedure 2.
- Correction of varus, valgus or post-traumatic deformity 3.
- Correction or revision of unsuccessful`osteotomy or arthrodesis 4 .
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The device is intended for use with bone cement (USA)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Acòde
(Division Sign-Off)
Division of General Restorative Devices K984054
510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)