(18 days)
Not Found
No
The document describes a mechanical hip prosthesis and its materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to treat a severely painful and/or disabled joint, avascular necrosis, or acute traumatic fracture of the femoral head or neck, which are considered therapeutic purposes.
No
The DePuy AML® Hip Prosthesis is a prosthetic implant used for total hip arthroplasty, which is a treatment, not a diagnostic procedure.
No
The device description clearly states it is a physical hip prosthesis manufactured from metal alloy with a porous coating, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a hip prosthesis, which is a surgically implanted device used to replace a damaged hip joint. Its purpose is to restore mobility and reduce pain by physically replacing the joint articulation.
- Lack of Diagnostic Activity: The device itself does not perform any tests on biological samples to diagnose or monitor a condition. It is a physical implant.
Therefore, based on the provided information, the DePuy AML® Hip Prosthesis is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Depuy AML® Hip Prosthesis is intended for use in total hip arthroplasty (THA) in either a cementless or cemented application. Total hip arthroplasy 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.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The AML® Hip Stem is indicated for cementless use with 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 prosthesis to the bone cement.
Product codes
LPH
Device Description
The subject device, DePuy AML® Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobalt-chrome molybdenum alloy bead 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. The stems are available in 10.5 and 12.0 mm sizes.
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
JUL 17 2006
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
EST REG No.. 1818910 |
|-----------------|--------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Anne Schuler
Sr Regulatory Affairs Associate
Tel: (574) 372-7098
Fax: (574) 371-4987 |
| DATE PREPARED: | June 26, 2006 |
| TRADE NAME: | DePuy AML® Hip Prosthesis |
| COMMON NAME: | Cementless or Cemented Porous Coated Hip Prosthesis |
CLASSIFICATION:
21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis, Class II Device
DEVICE PRODUCT CODE: 87 LPH
SUBSTANTIALLY EQUIVALENT DEVICES:
DePuy AML® Hip Prosthesis (K012364, cleared October 19, 2001) DePuy Solution System® Hip Prosthesis (K060581, cleared May 19, 2006) DePuy Vision Solution Hip Prosthesis (K953703, cleared February 1, 1996)
DEVICE DESCRIPTION:
The subject device, DePuy AML® Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobalt-chrome molybdenum alloy bead 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. The stems are available in 10.5 and 12.0 mm sizes.
INTENDED USE:
The Depuy AML® Hip Prosthesis is intended for use in total hip arthroplasty (THA) in either a cementless or cemented application. Total hip arthroplasy 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.
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SUBSTANTIAL EQUIVALENCE:
Based on the same intended use, indications, sterilization method, packaging and design, DePuy believes that the AML® Hip Prosthesis is substantially equivalent to the FDA-cleared DePuy AML® Hip Prosthesis (K012364), the Solution System® Hip Prosthesis (K060581) and the Vision Solution® Hip Prosthesis (K953763).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with intertwined snakes, a symbol often associated with medicine and healthcare. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2006
DePuy Orthopaedics, Inc. % Ms. Anne M. Schuler Sr. Regulatory Affairs Associate P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K061833
Trade/Device Name: Depuy AML® Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: June 28, 2006 Received: June 30, 2006
Dear Ms. Schuler:
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 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.
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Page 2 - Ms. Anne M. Schuler
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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson 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): Device Name: DePuy 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 ts 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.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. 5.
The AML® Hip Stem is indicated for cementless use with 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 prosthesis to the bone cement.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Verhare Budrund for MKM
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K061833 |
|---|---|
| --------------- | --------- |
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