(275 days)
When used with the AGC and Maxim Knee Systems, the indications for use of the Titanium Femoral Component include 1)painful and disabled knee joint resulting from osteoarthritis, rheumatiod arthritis, or traumatic arthritis where one or more compartments are involved, 2)failure of a previous joint replacement procedure. 3)correction of varus, valgus or post traumatic deformity, and 4)correction or revision of unsuccessful osteotomy or arthrodesis.
Device designed for use in patients with metal sensitivity.
Standard surgical and rehabilitative procedures are indicated with this device.
This device is a single use implant for use with bone cement
The femoral components of the AGC and Maxim Knee Systems are identical to their Co-Cr-Mo predecessors with the exception of the material used in manufacturing and a limited component availability. The AGC titanium component is available in primary universal components of five different sizes. The Maxim titanium component is available in five sizes of the primary universal component and five sizes of the revision universal component.
The titanium components are all N ion implanted, to Biomet engineering specification 1.4, in order to reduce the wear of both the titanium femoral component and the ultrahigh molecular weight polyethylene (UHMWPE).
The provided document is a 510(k) summary for a medical device, the Titanium Femoral Component, and does not contain information about acceptance criteria or a study proving the device meets said criteria.
Instead, the document focuses on:
- Substantial Equivalence: It asserts that the Titanium Femoral Component is substantially equivalent to other knee components already on the market from various manufacturers, including:
- Maxim Knee System (Biomet, Inc.)
- AGC 2000 Total Knee Prosthesis (Biomet, Inc.)
- MG II Total Knee (Zimmer, Inc.)
- Kinemax Plus Total Knee System (Howmedia, Inc.)
- Genesis Total Knee System (Smith & Nephew Richards, Inc.)
- Device Description: Details the material (titanium, N ion implanted) and available sizes, noting it's similar to predecessors made of Co-Cr-Mo.
- Intended Use: Specifies its use with the AGC and Maxim Knee Systems for conditions like osteoarthritis, rheumatoid arthritis, previous joint replacement failure, and deformity correction, particularly for patients with metal sensitivity and for use with bone cement.
- Potential Risks: Lists general risks associated with joint replacement devices.
- FDA Communication: A letter from the FDA confirming the finding of substantial equivalence, allowing the device to be marketed, with specific limitations regarding its use as a cemented device only.
Therefore, because this is a 510(k) submission based on substantial equivalence to predicate devices rather than a de novo submission requiring clinical performance data against specific acceptance criteria, it does not include the details requested in your prompt. The "acceptance criteria" here are implicitly satisfying the FDA's requirements for substantial equivalence to legally marketed predicate devices.
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MAR 1 0 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
Device: Titanium Femoral Component
Classification Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis (CFR 888.3560)
- Intended Use: When used with the AGC and Maxim Knee Systems, the indications for use of the Titanium Femoral Component include 1)painful and disabled knee joint resulting from osteoarthritis, rheumatiod arthritis, or traumatic arthritis where one or more compartments are involved, 2)failure of a previous joint replacement procedure. 3)correction of varus, valgus or post traumatic deformity, and 4)correction or revision of unsuccessful osteotomy or arthrodesis.
Device designed for use in patients with metal sensitivity.
Standard surgical and rehabilitative procedures are indicated with this device.
This device is a single use implant for use with bone cement
-
Device Description: The femoral components of the AGC and Maxim Knee Systems are identical to their Co-Cr-Mo predecessors with the exception of the material used in manufacturing and a limited component availability. The AGC titanium component is available in primary universal components of five different sizes. The Maxim titanium component is available in five sizes of the primary universal component and five sizes of the revision universal component.
The titanium components are all N ion implanted, to Biomet engineering specification 1.4, in order to reduce the wear of both the titanium femoral component and the ultrahigh molecular weight polyethylene (UHMWPE). -
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 Blood vessel damage Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migrating Fracture of the component Nerve damage
Soft tissue imbalance Delaved wound healing Metal sensitivity
Bone fracture Infection Hematoma Dislocation Excessive wear
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- Substantial Equivalence: In function and overall design, the Titanium Femoral Component is equivalent to other knee components on the market. These components include:
Maxim Knee System (Biomet, Inc., Warsaw, IN) AGC 2000 Total Knee Prosthesis (Biomet, Inc., Warsaw, IN) MG II Total Knee (Zimmer, Inc., Warsaw, IN) Kinemax Plus Total Knee System (Howmedia, Inc., Rutherford, NJ) Genesis Total Knee System (Smith & Nephew Richards, Inc., Memphis, TN)
:
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 1999
Mr. Fred McClure Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K981996 Re: Titanium Femoral Components Regulatory Class: II Product Code: JWH December 9, 1998 Dated: Received: December 10, 1998
Dear Mr. McClure:
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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone and Inconably therefore, market your device subject to the general controls provisions of the Act and the following limitations:
- This device may not be labeled or promoted for non-1. cemented use.
- All labeling for this device, including package label and 2. labeling included within the package, must prominently state that the device is intended for cemented use only.
- Any non-cemented fixation of this device is considered 3. investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Druq Administration (FDA) to conduct the investiqation.
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Page 2 - Mr. Fred McClure
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 In addition, FDA may publish further announcements action. 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 Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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
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Page 3 - Mr. Fred McClure
obtained from the Division of Small Manufacturers Assistance obtained from one (800) 638-2041 or (301) 443-6597 or at at Its Coll Irec nambor (o://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Zupp V. S. Sager
/ 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
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Page 1 of 1
510(k) NUMBER (IF KNOWN): _K981996
DEVICE NAME: Titanium Femoral Component
INDICATIONS FOR USE:
When used with the AGC and Maxim Knee Systems, the indications for use of the Titanium Femoral Component include 1)painful and disabled knee joint resulting from osteoarthritis, rheumatiod arthritis, or traumatic arthritis where one or more compartments are involved, 2)failure of a previous joint replacement procedure, 3)correction of varus, valgus or post traumatic deformity, and 4)correction or revision of unsuccessful osteotomy or arthrodesis.
Device designed for use in patients with metal sensitivity.
Standard surgical and rehabilitative procedures are indicated with this device.
This device is a single use implant for use with bone cement.
Kussell U. Hagen facsim
(Division Sign-Off) Division of General Restorative Devices 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| Prescription Use | |||
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or
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.