(87 days)
Fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.
Not Found
I am sorry, but the provided text is a letter from the FDA regarding a medical device clearance. It does not contain information about acceptance criteria, study details, or performance data for a device. The document is primarily about the regulatory approval of "Concert Radiopaque Bone Cement" and its intended use.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 8 2002
Mr. Roy Bogert VP of Engineering and Regulatory Affairs Immedica, Inc. 100 Passaic Avenue Chatham, New Jersey 07928
Re: K013755
Trade Name: Concert Radiopaque Bone Cement Regulation Number: 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: II Product Code: LOD Dated: November 9, 2001 Received: November 13, 2001
Dear Mr. Bogert:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becaon 9 ro(x) nevironment (for the indications for use to use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encrossure) to device Amendments, or to devices that have been reclassified in enacinent date of the Medical Dorios Faderal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provisions of the reasonal controls provisions of the Act. The general therefore, market the device, sabject to equirements for annual registration, listing of devices, Controls provisions or the receing, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (600 above) and additional controls. Existing major regulations (Frenariot Approval), it they of our Code of Federal Regulations, Title 21, Parts 800 to 895. alleount your do rive sent determination assumes compliance with the current Good A substantany equirement, 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 mspections, the Food and Dating may result in regulatory action. In addition, FDA may publish Comply with the Orill regulared 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to begin manuting , quivalence of your device to a legally marketed nonticate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Mr. Roy Bogert
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark H. 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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page 1 of 1
510(k) Number (if known): __ Kol 3755
Device Name: Concert™ Radiopaque Bone Cement
Indications For Use:
Fixation of prostheses to living bone in orthopedic musculoskeletal surgical I Tration of prostile505 to in this osteoarthritis, traumatic arthritis, osteoporosis, procedures for rhoumators anisease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
for Mark N Millerson
(Division Sign-Off)
Division of General, Restorative
and Neurolo...
| 510(k) Number | K013735 |
|---|---|
| --------------- | --------- |
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”