(73 days)
Not Found
No
The document describes a hip prosthesis and its intended use, materials, and predicate devices. There is no mention of AI or ML technology in the description or any of the provided sections.
Yes
Explanation: The device is intended to provide increased patient mobility and reduce pain by replacing a damaged hip joint, which are therapeutic goals.
No
The device described is a total hip arthroplasty component, which is a prosthetic implant used for treatment, not diagnosis. This is indicated by its "Intended Use/Indications for Use" which describes replacement of a damaged hip joint and "Device Description" which describes the manufacturing materials and physical properties of the hip prosthesis.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a hip prosthesis) intended to be surgically implanted into the human body to replace a damaged hip joint. It is used to improve mobility and reduce pain.
- Lack of In Vitro Testing: There is no mention of this device being used to test samples outside of the body. Its function is entirely within the body.
Therefore, based on the provided information, the DePuy Solution System® Hip Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Solution System® Hip Prosthesis is intended for use in total hip arthroplasty (THA) in either a cementless or cemented application. Total hp arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint provide into subser patients where 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 Solution System® Hip Stem is indicated for comentless 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 prosthesis to the bone cement.
Product codes (comma separated list FDA assigned to the subject device)
87 LPH, LPH
Device Description
The subject device, DePuy Solution System® Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobaltchrome 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, 12.0 and 13.5 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Kobo581 page 1 of 2
Way 1 9 2005
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 |
| TRADE NAME: | DePuy Solution System® Hip Prosthesis |
| COMMON NAME: | Cementless or Cemented Porous Coated Hip Prosthesis |
CLASSIFICATION:
21 CFR 888.3358: Hip joint metal/polymer semi-constrained porous coated uncemented prosthesis, Class II Device
DEVICE PRODUCT CODE:
87 LPH
SUBSTANTIALLY EQUIVALENT DEVICES:
DePuy Solution System® Hip Prostheses (K030979, cleared April 24, 2003) Depuy Summit™ Cemented Hip Prosthesis (K013352, cleared December 17, 2001) DePuy Vision Solution Hip Prosthesis (K953703, cleared February 1, 1996)
DEVICE DESCRIPTION:
The subject device, DePuy Solution System® Hip Prosthesis, is manufactured from ASTM F-799 Forged Controlled-Carbon Cobalt-Chromium-Molybdenum alloy and has a sintered cobaltchrome 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, 12.0 and 13.5 mm sizes.
0000004
1
Page 292
INTENDED USE:
The DePuy Solution System® Hip Prosthesis is intended for use in total hip arthroplasty (THA) in either a cementless or cemented application. Total hp arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint provide into subser patients where is evidence of sufficient sound bone to seat and support the components.
SUBSTANTIAL EQUIVALENCE:
Based on the same intended use, indications, sterilization method, packaging and design, DePuy believes that the Solution System® Hip Prosthesis is substantially equivalent to the FDA-cleared DePuy Solution System® Hip Prosthesis (K030979), the Vision Solution Hip Prosthesis (K953703) and the Depuy Summit™ Cemented Hip Prosthesis (K013352).
0000005
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2006
DePuy Orthopaedics Inc. c/o Ms. Anne M. Schuler P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K060581
Trade/Device Name: Depuy Solution System® 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: April 14, 2006
Dear Ms. Schuler:
Received: April 19, 2006
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
3
Page 2 - Ms. Anne M. Schuler
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- 1020. 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 yours,
Herbert Lerner ws
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): K06058/
Device Name: DePuy Solution System® 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, 1. 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 Solution System® Hip Stem is indicated for comentless 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 prosthesis to the bone cement.
Hulut Lemerico
Division of General, Restorative and Neurological Devices
510(k) Number Kol 0581
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)