(202 days)
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Not Found
No
The summary describes a hip implant system and its indications for use. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities typically associated with AI/ML medical devices.
Yes
The device is a hip system intended for use in total hip arthroplasty to treat various hip joint impairments and conditions, which falls under the definition of a therapeutic device designed to alleviate or cure a medical condition.
No
This device is described as a "Hip System" intended for use in total hip arthroplasty, indicating it is a prosthetic implant for surgical replacement of a hip joint, not a device used to diagnose medical conditions.
No
The device description explicitly lists hardware components: "Encompass™ Hip Stem, Tri-plus™ Acetabular Shell, Tri-plus™ DCM Liner". This indicates it is a physical implant system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation in the hip joint to treat various conditions affecting the hip. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The device components listed (Hip Stem, Acetabular Shell, Liner) are all parts of a hip replacement prosthesis, which is an implantable medical device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVDs are designed for these purposes.
In summary, this device is a surgical implant used for treatment, not a diagnostic tool used to test samples.
N/A
Intended Use / Indications for Use
The device is Intended for use in total hij› arthroplasty. The device is intended for uncemented, press-fit use only.
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- Notably impaired hip joint due to usteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
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- Previously failed surgery.
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- Proximal femoral neck fractures or dislocation.
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- Idiopathic avascular necrosis of the femoral head.
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- Non-union of proximal femoral ne :k fractures.
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- Treatment of fractures that are un nanageable using other forms of therapy.
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- Benign or malignant bone tumors congenital dysplasia or other structural abnormalities where sufficient bo re stock exists to properly seat the prosthesis.
Product codes
LPH, MBL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hip joint, femoral head, proximal femoral
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings, and a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around it. The eagle is facing to the right.
APR 1 ] 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William J. Griffin Regulatory and Clinical Affairs Manager Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020
Re: K042565
Trade/Device Name: Encompass™ Plasma Sprayed, Press-fit Hip System: Encompass™ Hip Stem, Tri-plus™ Acetabular Shell, Tri-plus™ DCM Liner Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, MBL Dated: March 11, 2005 Received: March 14, 2005
Dear Mr. Griffin:
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.
1
Page 2 - Mr. William J. Griffin
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 yours,
Atyck Rhodes
Miriam Provost, Ph.D.
Miriam Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Ortho Development - K042565 - Porc us, Press-Fit Hip System, Plasma Coated
Indicat ons for Use
K042565 510(k) Number (if known): ____
Device Name: Encompass™ Plasma Sprayed , Press-Fit Hip System
Indications for Use
The device is Intended for use in total hij› arthroplasty. The device is intended for uncemented, press-fit use only.
-
- Notably impaired hip joint due to usteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
-
- Previously failed surgery.
-
- Proximal femoral neck fractures or dislocation.
-
- Idiopathic avascular necrosis of the femoral head.
-
- Non-union of proximal femoral ne :k fractures.
-
- Treatment of fractures that are un nanageable using other forms of therapy.
-
- Benign or malignant bone tumors congenital dysplasia or other structural abnormalities where sufficient bo re stock exists to properly seat the prosthesis.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Oflice of Device Evaluation (ODE)
Stud
(Division Sign-Off)
Division of General. Restorative,
and Neurological Devices
510(k) Numbe