(211 days)
The indications for Biomet's Non-Cemented Porous Coated Knee Components include:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved.
- Correction of varus, valgus or posttraumatic deformity
- Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
All devices are metallic knee femoral and tibial base-plate components. The components are identical to those cleared in previous 510(k) submissions for cemented application.
The porous coated components that are subject of this 510(k) are intended for use with components (tibial bearings, all polyethylene patellar components, non-porous coated femoral and tibial base-plates) previously covered by 510(k) submission for cemented use.
This 510(k) summary for the Biomet's Non-Cemented Porous Coated Knee Components explicitly states "Clinical and Non-Clinical Testing: None provided." Therefore, there is no study described in this document that proves the device meets acceptance criteria.
The submission is based on substantial equivalence to predicate devices that were previously cleared for cemented application. The current submission seeks clearance for non-cemented application of the same metallic knee femoral and tibial base-plate components.
As no testing was provided, the following information cannot be extracted from the document:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided as no testing was submitted.
- Sample sizes used for the test set and the data provenance: Not applicable, as no test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, no studies were done.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable, as no testing and thus no ground truth establishment for a test set occurred.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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JUN - 2 2004
510(k) Summary
Applicant/Sponsor: Biomet, Inc.
Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist
Proprietary Names: AGC® Total Knee, Ascent™ Total Knee System, Maxim® Complete Knee System, Maxim® Accel Knee System also known as the Vanguard Knee System
Common Name: Porous coated knee replacement components
Classification Name: Knee ioint patellofemorotibial metal/polymer porous coated uncemented (21 CFR 888.3565)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: AGC® Total Knee System Knee (K833921, K912245), Ascent™ Total Knee System (K982869, K994326), Maxim® Complete Knee System (K915132), Maxim® Accel Knee System (Vanguard) (K023546), Trabecular Metal Tibial and Patellar Components for the NexGen Knee System (K031462), Genesis II Total Knee System (K030612), Profix Total Knee System (K030623)
Device Description: All devices are metallic knee femoral and tibial base-plate components. The components are identical to those cleared in previous 510(k) submissions for cemented application.
The porous coated components that are subject of this 510(k) are intended for use with components (tibial bearings, all polyethylene patellar components, non-porous coated femoral and tibial base-plates) previously covered by 510(k) submission for cemented use.
Intended Use: Non-cemented total knee replacement
Indications for Use: The indications for Biomet's Non-Cemented Porous Coated Knee Components include:
-
- Painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic arthritis, where one or more compartments are involved.
-
- Correction of varus, valgus or posttraumatic deformity
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Summary of Technologies: The devices to be covered by this 510(k) are identical to devices covered by previously cleared 510(k) submissions for cemented application.
Clinical and Non-Clinical Testing: None provided
All trademarks are property of Biomet, Inc.
MAHANG, ADDRESS PO Box 587 Warsaw, IN 46581 058
Smenna, Appriss SO E. Bell Drive Warsaw. IN 1658 !
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN -- 2 2004
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
:
Re: K033489
Trade/Device Name: Biomet's Non-Cemented Porous Coated Knee Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. Regulatory Class: II Product Code: MBH Dated: March 3, 2004 Received: March 4, 2004
Dear Ms. Beres:
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 for abound in 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 - Ms. Patricia Sandborn Beres
This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket 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 yours,
Miriam C. Provost
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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Indications for Use
510(k) Number (if known): K033489
Device Name: Biomet's Non-Cemented Porous Coated Knee Components
Indications For Use: The indications for Biomet's Non-Cemented Porous Coated Knee Components include:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved.
-
- Correction of varus, valgus or posttraumatic deformity
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
Prescription Use × (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 Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
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510(k) Number K633489
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.