(87 days)
The Duraloc® Option Acetabular Cup System is for total hip replacement.
A 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:
-
- 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. 3.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The acetabular cups are indicated for cementless application.
The Duraloc® Option Acctabular Cup System consists of a UHMWPE acetabular cup liner secured to a porous-coated Ti-6A1-4V acetabular shell. The acetabular system articulates with previously cleared 28mm fernoral heads, as well as with 22.225mm femoral heads internally documented by DePuy as line extensions to femoral heads cleared in K920317 and K980513.
The 28mm femoral heads were cleared in K920317 on March 19, 1992, K893872 on July 11, 1989, K883460 on October 11, 1998, K860701 on March 19, 1986, K891082 on June 9, 1989 and K011533 on January 28, 2002.
The acetabular cups are sized from 46mm to 66mm, in 2 mm increments. The liners are available in two styles: neutral and lipped. Liners with a 22,225mm inner diameter are offered in the outer diameter of 46mm. Liners with a 28mm inner diameter are offered in outer diameters of 48/50mm, 52mm, 54/56mm, 58/60mm, and 62/64/66mm.
The liner interlock allows the liner to be rotated to match the patient's anatomy. A locking ring, manufactured from Co-Cr-W-Ni alloy, is used to secure the liner.
The cups and liners are intended to be used in total hip arthroplasty to provide increased patient mobility and to reduce pain by replacing damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components.
The acetabular cups are indicated for cementless application.
The provided text describes a 510(k) summary for a medical device, the Duraloc® Option Acetabular Cup System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving device efficacy through clinical studies with acceptance criteria in the way a new drug or novel medical device might.
The 510(k) summary does not include:
- Acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for an AI/CADe device.
- Details of a study proving the device meets specific performance acceptance criteria.
- Information on sample sizes, ground truth establishment, expert qualifications, or adjudication methods for a diagnostic algorithm.
- Any mention of AI, CADe, or image analysis.
- Multireader multi-case (MRMC) studies or standalone performance studies.
Instead, the document focuses on:
- Substantial Equivalence: Comparing the Duraloc® Option Acetabular Cup System to previously cleared hip prosthesis devices (DePuy Pinnacle Acetabular System and DePuy Duraloc Cementless Acetabular Cup System).
- Device Description: Detailing the components and materials of the acetabular cup system.
- Intended Use and Indications: Specifying the conditions for which the device is intended, which are related to total hip arthroplasty to replace damaged hip joint articulation in various severe conditions like osteoarthritis, traumatic arthritis, avascular necrosis, etc.
Therefore, it is not possible to answer the detailed questions about acceptance criteria, study design, expert involvement, or AI performance based on the provided text. The document pertains to a hardware medical device (hip prosthesis) seeking 510(k) clearance, not a software/AI medical device that would have performance metrics like those requested in the prompt.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF SPONSOR: | DePuy® Inc.P.O. Box 988Warsaw, IN 46581-0988Registration Number: 1818910 |
|---|---|
| 510(k) CONTACT: | Dina L. Weissman, J.D.Legal Consultant, Regulatory AffairsTelephone: (574) 371-4905Fax: (574) 371-4987Email: dweissma@dpyus.jnj.com |
| TRADE NAME:COMMON NAME: | Duraloc® Option Acetabular Cup SystemHip Prosthesis |
| REGULATORY CLASSIFICATION: | 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis888.3353 Prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented, CLASS II |
DEVICE PRODUCT CODE: 87 LPH and 87 LZO
SUBSTANTIALLY EQUIVALENT DEVICES:
- DePuy Pinnacle Acetabular System (K001534) .
- DePuy Duraloc Cementless Acetabular Cup System (K961186) .
DEVICE DESCRIPTION AND INTENDED USE:
The Duraloc® Option Acctabular Cup System consists of a UHMWPE acetabular cup liner secured to a porous-coated Ti-6A1-4V acetabular shell. The acetabular system articulates with previously cleared 28mm fernoral heads, as well as with 22.225mm femoral heads internally documented by DePuy as line extensions to femoral heads cleared in K920317 and K980513.
The 28mm femoral heads were cleared in K920317 on March 19, 1992, K893872 on July 11, 1989, K883460 on October 11, 1998, K860701 on March 19, 1986, K891082 on June 9, 1989 and K011533 on January 28, 2002.
The acetabular cups are sized from 46mm to 66mm, in 2 mm increments. The liners are available in two styles: neutral and lipped. Liners with a 22,225mm inner diameter are offered in the outer diameter of 46mm. Liners with a 28mm inner diameter are offered in outer diameters of 48/50mm, 52mm, 54/56mm, 58/60mm, and 62/64/66mm.
The liner interlock allows the liner to be rotated to match the patient's anatomy. A locking ring, manufactured from Co-Cr-W-Ni alloy, is used to secure the liner.
The cups and liners are intended to be used in total hip arthroplasty to provide increased patient mobility and to reduce pain by replacing damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components.
The acetabular cups are indicated for cementless application.
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Image /page/1/Picture/1 description: The image shows a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2004
Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy, Inc. P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K040544
Trade/Device Name: Duraloc® Option Acetabular Cup System Regulation Number: 21 CFR 888.3358 and 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis and Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Regulatory Class: II
Product Codc: LPH and LZO Dated: March 1, 2004 Received: March 2, 2004
Dear Dr. Weissman:
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 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) 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
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Page 2 - Dina L. Weissman, J.D.
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated 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.
Sincerely yours,
Mark A. Milliman
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): K040544 Device Name: Duraloc® Option Acetabular Cup System Indications for Use:
The Duraloc® Option Acetabular Cup System is for total hip replacement.
A 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:
-
- 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. 3.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The acetabular cups are indicated for cementless application.
Prescription Use XXXX Over-The-Counter Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millkeum
Division of General, Restorative and Neurological Devices
K040544
mber
510(k) Number.
§ 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.