(85 days)
No
The document describes a traditional hip implant device and does not mention any AI or ML components or functionalities.
Yes
The device is a total hip arthroplasty system, which is a medical intervention designed to treat and alleviate painful and/or disabled hip joints, thereby restoring function and mobility.
No
The device is a total hip arthroplasty (hip replacement) intended to replace a damaged hip joint, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a hip stem manufactured from metal alloy with a porous coating, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The provided text describes a total hip arthroplasty device, specifically a hip stem. This is an implantable medical device used inside the body to replace a damaged joint.
- Intended Use: The intended use clearly states it's for replacing the damaged hip joint articulation in patients, which is a surgical procedure performed in vivo.
The description, intended use, and nature of the device all point to it being a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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 or 3. neck.
- Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. 5.
The AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prostheses to the bone cement.
Product codes
87LPH, LPH, JDI
Device Description
The AML hip stem is manufactured from ASTM F-75 Cobalt-Chromium-Molybdenum alloy and has a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
OCT 1 9 2001
K0/>364
108 2
510(k) Summary
DePuy Orthopaedics, Inc. Name of Sponsor: 700 Orthopaedic Drive Warsaw. Indiana 46581-0988 Est. Reg. No. 1818910 Marcia J. Arentz 510(k) Contact: Senior Regulatory Associate Phone: (219) 371-4944 FAX: (219) 371-4987 AML® Hip Prosthesis Trade Name: Total Hip Joint Replacement Prosthesis with porous Common Name: coating Class II Device per 21 CFR 888.3358: Classification: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis Code: 87LPH Prosthesis Hip Semi-constrained, Device Product Code: Metal/Polymer, Porous Uncemented No performance standards have been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for femoral hip stems. Porocoat® Prodigy™ Hip Prosthesis K931641 Substantially Equivalent Device: Vision AML® Hip Prosthesis K953694 AML Hip Prosthesis K003800 The AML hip stem is manufactured from ASTM F-Device Descriptions: 75 Cobalt-Chromium-Molybdenum alloy and has a cobalt-chrome-molybdenum alloy bead sintered porous coating (Porocoat®) applied to the stem. The porous coating is applied to the entire stem with the exception of the tapered stem tip region. Total hip arthroplasty is intended to provide increased Intended use: 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.
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510(k) Summary (continued)
20P2
Indications for use:
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 or 3. neck.
- Failed previous hip surgery including joint 4. reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. ડ.
Substantial equivalence:
Based on similarities of design, commonly used materials, identical sterilization processes, the same indications for use and intended use, DePuy believes that the modified AML Hip Prosthesis is substantially equivalent to the FDA-cleared Prodigy Hip Prosthesis system, the Vision AML Hip System and the AML Hip Prosthesis.
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Image /page/2/Picture/1 description: The image shows a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
OCT 1 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marcia J. Arentz Senior Regulatory Associate DePuy, Inc. P.O. Box 988 700 Orthopedic Drive Warsaw, Indiana 46581-0988
Re: K012364 Trade Name: AML Hip Prosthesis Regulation Number: 21 CFR 888.3358, 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous Coated Uncemented Prosthesis and Hip Joint Metal/Polymer/Metal Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: LPH, JDI Dated: July 24, 2001 Received: July 26, 2001
Dear Ms. Arentz:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have levice your becally in (x).) it is substantially equivalent (for the indications for use above and we nave determined an marketed in interstate commerce prior to May 28, 1976, the stated in the cherosure) to device Amendments, or to devices that have been reclassified in enacificin date of the Medical Dories Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provincils of the general controls provisions of the Act. The general therefore, mance the Act include requirements for annual registration, listing of devices, controls provisions or the free headling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see acover) and additional controls. Existing major regulations (1 renarch Approval), it they of Sale of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good A substantially equirante 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 Drug Nammasult in regulatory action. In addition, FDA may publish comply with the Crici rogerming 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 - Mr. Don Selvey
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Susan Walker, us
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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):_Ko 1> GG
Device Name: AML Hip Prosthesis
Indications for Use:
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.
OR
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- ર. Certain cases of ankylosis.
The AML® Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prostheses to the bone cement.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
R. Mark McMillan
isricing Sionral. Restorative