(42 days)
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1) a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia: 2) avascular necrosis of the femoral head; 3) acute traumatic fracture of the femoral head or neck, 4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; and 5) certain cases of ankylosis.
Cemented Components:
Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement.
The subject device is a cobalt chromium molybdenum alloy modular and smooth stemmed prosthesis that is intended for cemented use to replace the femoral portion of the hip joint in total hip arthroplasty.
This document describes a 510(k) premarket notification for a medical device, the Excel Fracture Cemented Hip Stem - Size 1. The document is primarily focused on demonstrating substantial equivalence to a previously cleared device, not on presenting a study with acceptance criteria and device performance metrics.
Therefore, the requested information regarding acceptance criteria, device performance, study sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.
The 510(k) summary (K011367) states that the "[size 1 Excel Fracture Cemented Hip Stem is identical in design, material, manufacturing process and intended use to the Excel Fracture Cemented Hip Stem cleared as Response 2000 Cemented Hip Stem] (K00432), except for being a smaller size." This indicates that the regulatory approval relies on the pre-existing approval of the predicate device, assuming similar safety and effectiveness due to the high degree of similarity and the only difference being a smaller size.
Therefore, the information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria is not present in the provided 510(k) summary. These details would typically be found in the original submission for the predicate device (Response 2000 Cemented Hip Stem, K00432) or in a more comprehensive technical document not included here.
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011367
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
NAME OF FIRM:
510(K) CONTACT:
TRADE NAME:
COMMON NAME:
CLASSIFICATION:
DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Sally Foust Sr. Regulatory Associate (219) 371-4905 FAX (219) 371-4987
Excel Fracture Cemented Hip Stem
Hip Prosthesis
Class II device per 21 CFR, 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.
DEVICE PRODUCT CODE:
87 JDI
SUBSTANTIALLY EQUIVALENT DEVICE
Excel Fracture Cemented Hip Stem (cleared as Response 2000 Cemented Hip Stem) K00432
DEVICE DESCRIPTION AND INTENDED USE:
The subject device is a cobalt chromium molybdenum alloy modular and smooth stemmed prosthesis that is intended for cemented use to replace the femoral portion of the hip joint in total hip arthroplasty. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1) a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia: 2) avascular necrosis of the femoral head; 3) acute traumatic fracture of the femoral head or neck, 4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; and 5) certain cases of ankylosis.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Except for being a smaller size, the size 1 Excel Fracture Cemented Hip Stem is identical in design, material, manufacturing process and intended use to the Excel Fracture Cemented Hip Stem cleared as Response 2000 Cemented Hip Stem.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is written in a sans-serif font and is arranged in a circular pattern.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2001
Ms. Sally Foust Senior Regulatory Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw. Indiana 46581
Re: K011367
Trade Name: Excel Fracture Cemented Hip Stem - Size 1 Regulation Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: May 3, 2001 Received: May 4, 2001
Dear Ms. Foust:
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 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 (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.
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.
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Page 2 - Ms. Sally Foust
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,
C. Colin M. Wittwer, Ph.D., M.D.
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
510(k) Number (if known)
Device Name: Excel Fracture Cemented Hip Stem
INDICATIONS:
INDICATIONS.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by Total mp articulation in interiot articulation in patients where there is evidence of replacing the damaged seen and support the components. Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, r anot provious mp broplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
Cemented Components:
Cemented Components.
Femoral stem and acetabular cup total hip components labeled "For cemented use only" are indicated only for use with bone cement.
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(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011367
Over-The Counter Use
Prescription Use X 801.109)
OR
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§ 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.