(22 days)
The CB DDH Femoral Stem is intended for noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and revisions of hip replacement components.
The Co-Cr-Mo Color Buffed DDH Femoral Stem is designed to replace a diseased or damaged femoral neck. The proximal area of the stem has been reduced slightly to allow a better fit in patients with more of a cylindrical canal.
This 510(k) summary for the Color Buffed (CB) DDH Femoral Stem explicitly states that clinical testing was NOT used for the support of this 510(k). Instead, mechanical testing was used to demonstrate substantial equivalence to a previously cleared device (K992903).
Therefore, the requested information regarding acceptance criteria derived from clinical studies, device performance in clinical settings, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be provided based on the provided document.
The document indicates:
- Clinical Testing: "Clinical data was not used for the support of this 510(K)."
- Non-Clinical Testing: "Mechanical testing was used to demonstrate substantial equivalence."
Without clinical data, none of the detailed information you requested regarding acceptance criteria and a study proving those criteria are met (which would inherently involve clinical performance metrics) can be extracted from this submission.
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KO12019
JUL 2 0 2001
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Summary of Safety and Effectiveness
Applicant/Sponsor: Biomet Orthopedics, Inc. 56 E. Bell Drive Warsaw, Indiana 46582
- Dalene T. Binkley Contact Person: Telephone: (219) 267-6639 Fax: (219) 372-1683
Proprietary Name: Color Buffed (CB) DDH Femoral Stem
Common Name: Femoral Hip Stem
Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis.
Device Description: The Co-Cr-Mo Color Buffed DDH Femoral Stem is designed to replace a diseased or damaged femoral neck. The proximal area of the stem has been reduced slightly to allow a better fit in patients with more of a cylindrical canal.
Intended Use: The CB DDH Femoral Stem is intended for noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and revisions of hip replacement components.
Basis of Substantial Equivalence: The CB DDH Femoral Stem is nearly identical to the Color Buffed Cemented Femoral (K992903) that was cleared previously. The intended use, material, stem finish, diameter and over-all length is the same. The only minor changes to the femoral were the reductions in neck length and angle and proximal body.
Non-Clinical Testing: Mechanical testing was used to demostrate substantial equivalence.
Clinical Testing: Clinical data was not used for the support of this 510(K).
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
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00046
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@hiomet.com
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.
Public Health Service
JUL 2 0 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet, Inc. P.O.Box 587 Warsaw, Indiana 46581
Re: K012019
Trade Name: Color Buffed (CB) DDH Femoral Stem Regulatory Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: June 26, 2001 Received: June 28, 2001
Dear Ms. Binkley:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have neviewed your becaon b I (x) it is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreased to device Amendments, or to devices that have been reclassified in may enacificin uate of the Medical Doviet Panesal Food, Drug, and Cosmetic Act (Act). You may, a therefore, market the device, subject to the general control provisions of the Act. The general therefore, market the device, but include requirements for annual registration, listing of devices, control provisions of the river morations against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see above) into such additional controls. Existing major regulations (Premarket Approval), it they of Subject to ade of Federal Regulations, Title 21, Parts 800 to 895. arrecting your devroe car or reanination assumes compliance with the current Good A substantially cquiralent decemination 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 Inspections, the Food and Drag Temission in regulatory action. In addition, FDA may publish comply with the GMI Tegarater in the Federal Register. Please note: this response to your premarks contrission 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) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed nonication. The I Driving of sustin for your device and thus, permits your device to proceed to the market.
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Page 2 - Ms. Dalene T. Binkley
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, (201) 591 1059. Traditional (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,
СВтокилитогр
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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510 (k) NUMBER (IF KNOWN):
DEVICE NAME: Color Buffed (CB) DDH Femoral Stem
INDICATIONS FOR USE:
The CB DDH Femoral Stem is intended for noninflammatory degenerative joint disease The CB DDH Femoral Stein is intended for theumatoid arthreis; correction of finctional
including osteoarthritis and avascular necrosis; theumatoid arterio frequents of the including osteourinis and avascular necrosis, hisacture, and trochanteric fractures of the deformity; treatment of not-unfolion, ichorar nook freetars, and revisions of of hip replacement components.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
DSmitchell MD for our
(Division Sign-Off Division of General, Restorative and Neurological Device
00008
510(k) Number K012019
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing 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.