(102 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:
- Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head 3. or neck.
- Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarhroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The non-porous Corail AMT Hip Stem is indicated for cementless use only.
- Certain cases of ankylosis.
The Corail AMT Hip is a tapered stem available both collarless and collared. This hip stem is manufactured from F-136 titanium (Ti-6Al-4V) and has a layer of hydroxyapatite (HA) coating applied. The Corail AMT Hip is available in standard offset, lateralized high offset and a Coxa vara lateralized offset. The standard offset stems, collared and collarless, are available in 11 sizes (Size 8 to Size 20). The lateralized high offset and the lateralized Coxa vara high offset are available in 8 sizes (Size 9 to Size 16).
The provided text is a 510(k) summary for the Corail AMT™ Hip Prosthesis. It does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document primarily focuses on:
- Device Description: What the Corail AMT Hip is, its materials, and available sizes.
- Intended Use and Indications for Use: Why the device is used and the conditions it's designed to treat (e.g., osteoarthritis, avascular necrosis).
- Substantial Equivalence: A declaration that the Corail AMT Hip is substantially equivalent to previously marketed predicate devices (HA Coating K953111 DePuy Corail® Hip stem and DePuy Titan™ K001991). This is the primary mechanism for clearance for Class II and some Class III devices in the US, rather than proving performance against specific acceptance criteria.
- Regulatory Classification: Identifying the device as Class II and Class III and the relevant CFR sections.
- FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot fulfill your request for: Acceptance Criteria, Reported Device Performance, Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC study details, Standalone study details, Type of Ground Truth, Training Set Sample Size, or how Training Set Ground Truth was established.
The 510(k) process for this type of device (a hip prosthesis) typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that establish acceptance criteria and performance against them in the way a novel AI or diagnostic device might. The focus is on comparing the new device's technological characteristics, materials, and intended use to those of the predicate device. If they are sufficiently similar, the new device is deemed as safe and effective as the predicate.
{0}------------------------------------------------
FEB 1 1 2005
K042992
510(k) Summary
Name of Sponsor:
510(k) Contact:
Trade Name:
Common Name:
Device Classification And Product Code:
Substantially Equivalent Device:
Device Descriptions:
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Est. Reg. No. 1818910
Nancy S. Friddle Senior Regulatory Associate Phone: (574) 371-4923 FAX: (574) 371-4987
Corail AMTTM Hip Prosthesis
Total Hip Prosthesis
Class II
LZO; 21 CFR 888.3353; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Class III
KWA; 21 CFR 888.3330; Hip joint metal/metal semi-constrained, with an uncemented acctabular component, prosthesis
HA Coating K953111 DePuy Corail® Hip stem DePuy Titan™ K001991 (Marketed by name Summit™)
The Corail AMT Hip is a tapered stem available both collarless and collared. This hip stem is manufactured from F-136 titanium (Ti-6Al-4V) and has a layer of hydroxyapatite (HA) coating applied. The Corail AMT Hip is available in standard offset, lateralized high offset and a Coxa vara lateralized offset. The standard offset
00000006
{1}------------------------------------------------
510(k) Summary (continued)
stems, collared and collarless, are available in 11 sizes (Size 8 to Size 20). The lateralized high offset and the lateralized Coxa vara high offset are available in 8 sizes (Size 9 to Size 16).
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:
- Severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head 3. or neck.
- Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarhroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The non-porous Corail AMT Hip Stem is indicated for cementless use only.
The Corail AMT Hip Prosthesis has the same intended use, is made from the same material and has a similar design as the predicate devices and is therefore substantially equivalent.
No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems.
0000007
Intended use:
Indications for use:
Substantial equivalence:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird, represented by three curved lines that suggest wings or feathers.
Public Health Service
ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ
ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
FEB 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nancy S. Friddle Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K042992
Trade/Device Name: Corail AMTTM Hip Prosthesis Regulation Number: 21 CFR 888.3330 and 21 CFR 888.3353 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis and Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Regulatory Class: III Product Code: KWA, LZO, LWJ, and MEH Dated: December 30, 2004 Received: January 3, 2005
Dear Ms. Friddle:
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.
{3}------------------------------------------------
Page 2 - Ms. Nancy S. Friddle
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 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 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), please contact the Office of Compliance at 240-276-0120. 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/industry/support/index.html.
Sincerely vours.
Mark McMillan
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use 510(k) Number (if known): _ KO42992 Corail AMTTM Hip Prosthesis Device Name:
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 ostcoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral hoad or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. న్న
The non-porous Corail AMT Hip Stem is indicated for cementless use only.
Over-The-Counter Use Prescription Usc ਮ 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. Millison
Division of General, Restorative, and Neurological Devices
KC42992
510(k) Number-
0000008
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.