(124 days)
The DePuy Duraloc Acetabular Cup Liners are intended to be used with the Duraloc System Acetabular Cups to resurface the acetabular socket in cemented or cementless total hip arthroplasty.
The subject DePuy Duraloc Acetabular Cup Liners are polyethylene acetabular cup liners which are available with 28mm or 32mm inner diameters, and with a neutral or a 10° lip. The 28mm liners are available in sizes to fit Duraloc metal acctabular shells with outer diameters of 48-74mm. The 32mm liners are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 52-74mm. The Duraloc polyethylene liners are locked into the Duraloc metal shells with a metal wire locking ring which is supplied with the metal shells. The subject polyethylene liners are identical in design to the acetabular cup liners cleared with the Modified DePuy Acetabular Cup System and the DePuy Modified AML+ Acetabular Cup System. The only difference between the subject Duraloc polyethylene liners and those that have been previously cleared by FDA is that the subject liners are manufactured from crosslinked polyethylene which has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to oxidation compared to gamma radiation sterilized standard UHMWPE.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) premarket notification letter from the FDA to DePuy Inc. regarding their Duraloc® Acetabular Cup System. It confirms that the device is substantially equivalent to previously marketed devices and can be brought to market.
The information provided includes:
- Device name and intended use.
- Company contact information.
- Regulatory classification and product codes.
- A brief description of the device's design and its manufacturing from crosslinked polyethylene.
- The FDA's finding of substantial equivalence based on the provided submission.
However, it does not include any details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
- Whether a multi-reader, multi-case comparative effectiveness study was done, or any effect sizes of human readers with/without AI assistance.
- Whether a standalone algorithm performance study was done.
- The type of ground truth used.
- Sample size for the training set or how ground truth for the training set was established.
This type of information is typically found in design validation reports or clinical study summaries, which are not part of this particular FDA correspondence. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive performance studies in all cases.
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| NAME OF FIRM: | DePuy Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988 |
|---|---|
| 510(k) CONTACT: | Cheryl HastingsManager, Clinical Affairs |
| TRADE NAME: | DePuy Duraloc® Acetabular Cup System |
| COMMON NAME: | Acetabular Cup Prosthesis |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrainedcementless prosthesis |
| DEVICE PRODUCT CODE: | 87 LPH |
| SUBSTANTIALLY EQUIVALENTDEVICES: | Modified DePuy Acetabular Cup System |
DePuy Modified AML+ Acetabular Cup System
DEVICE DESCRIPTION AND INTENDED USE:
The subject DePuy Duraloc Acetabular Cup Liners are polyethylene acetabular cup liners which are available with 28mm or 32mm inner diameters, and with a neutral or a 10° lip. The 28mm liners are available in sizes to fit Duraloc metal acctabular shells with outer diameters of 48-74mm. The 32mm liners are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 52-74mm. The Duraloc polyethylene liners are locked into the Duraloc metal shells with a metal wire locking ring which is supplied with the metal shells. The subject polyethylene liners are identical in design to the acetabular cup liners cleared with the Modified DePuy Acetabular Cup System and the DePuy Modified AML+ Acetabular Cup System.
The only difference between the subject Duraloc polyethylene liners and those that have been previously cleared by FDA is that the subject liners are manufactured from crosslinked polyethylene which has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to oxidation compared to gamma radiation sterilized standard UHMWPE.
The DePuy Duraloc Acetabular Cup Liners are intended to be used with the DePuy Duraloc metal acetabular shells to resurface the acetabular socket in cemented or cementless total hip replacement
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Hastings Manager, Clinical Affairs DePuy Inc. P.O. Box 988 700 Orthopaedic Drive 46581-0988 Warsaw, Indiana
NOV 1 2 1997
K972596 Re: DePuy Duraloc® Acetabular Cup System Trade Name: Regulatory Class: II Product Codes: LPH and JDI Dated: October 22, 1997 Received: October 23, 1997
Dear Ms. Hastings:
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, Druq, 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 Requlations, Title 21, Parts 800 to 895. ਉ 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 regulations.
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Page 2 - Ms. Cheryl Hastings
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.
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
follyfe
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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510(k) Number (if known) _K972596
Device Name DePuy Duraloc Acetabular Cup Liners
Indications for Use:
The DePuy Duraloc Acetabular Cup Liners are intended to be used with the Duraloc System Acetabular Cups to resurface the acetabular socket in cemented or cementless total hip arthroplasty.
Concurrence of CDRH, Office of Device Evaluation
bcada
(Division Sign-Off)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972596
Prescription Use _ X
OR (Per 21 CFR 801.109) Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
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§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.