(83 days)
Not Found
Not Found
No
The provided 510(k) summary focuses solely on the intended use and indications for a total hip arthroplasty device and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is intended for use in total hip arthroplasty to treat various hip joint impairments and conditions, which directly addresses medical conditions and restores function.
No
Explanation: The device is intended for total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint. This indicates a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The provided text only describes the intended use and indications for use of a total hip arthroplasty device. It does not contain any information about the device's description, particularly whether it is software-only or includes hardware components. The indications clearly point to a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for total hip arthroplasty, which is a surgical procedure involving the replacement of a joint. This is a therapeutic intervention performed directly on the patient's body.
- Indications for Use: The indications listed are all conditions affecting the hip joint and surrounding bone, requiring surgical intervention.
- Anatomical Site: The anatomical sites mentioned (Hip joint, femoral head, proximal femoral neck) are all parts of the human body where a surgical implant would be placed.
In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
This device is a surgical implant used inside the body (in vivo) for treatment. Therefore, it does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only.
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- Notably impaired hip joint due to osteoarthritis, 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 neck fractures.
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- Treatment of fractures that are unmanageable using other forms of therapy.
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- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Product codes
LPH, MBL
Device Description
Not Found. Partial information: Encompass™ Press-Fit Hip Stem, 10x17 and 12x17 Extended Stems
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head
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.
Not Found
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
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol with three curved lines forming its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2006
Mr. William J. Griffin Manager, Regulatory and Clinical Affairs Ortho Development Corporation 12187 S. Business Park Drive Draper, Utah 84020
Received: January 26, 2006
Re: K053293
KUS3293
Trade/Device Name: Encompass™ Press-Fit Hip Stem, 10x17 and 12x17 Extended Stems 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: January 24, 2006
Dear Mr. Griffin:
We have reviewed your Section 510(k) premarket notification of intent to market the devices WE liave reviewed your bection 910(t) promises are substantially equivalent (for the relerenced above and nave determined re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interslate comments, or to to May 20, 1978, the endedations of the provisions of the Amendments, of to devices that nave been require approval of a premarket approval of a premarket approval rederal Food, Drug, and Cosmette rior ( roo ( roo ket the device, subject to the general controls application (PMA). Tou may, mercione, market ins act include requirements for annual provisions of the Act. "The general controls provisions proctice, labeling, and prohibitions against misbranding and adulteration.
If your devices is classified (see above) into either class II (Special Controls) or class III (PMA), If your devices is classified (sec above) into it visting major regulations affecting your device
they may be subject to such additional controls. Existing major they may be subject to saen additional bonations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Ood or ements 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 devices comply with other requirements of the Act that FDA has made a decemmandi that young ther Federal agencies. You must or any Pederal Statutes and regulations adminding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), adomig (21 OFR Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Griffin
This letter will allow you to begin marketing your devices as described in your Section > 19(k) I his letter will anow you to ocgain marketing your avvivalence of your devices to + 'egally premarket notification. "The PDF Intamig of basication for your device and thus, permits your devices to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do not the cated on the more the regulation carithed, Contact the Office of Comphance at (210) 276-01607 (21CFR Part 807.97). You may >blain " Misoranding by reference to premarker notifications of Single the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Oolisanner Filoww.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Ortho Development -- K053293 -- Press-Fit Hip Stem Encompass 10x17 and 12x17 Extended Stem Sizes
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Encompass™ Press-Fit Hip Stem, 10x17 and 12x17 Extended Stems
Indications for Use
The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only.
-
- Notably impaired hip joint due to osteoarthritis, 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 neck fractures.
-
- Treatment of fractures that are unmanageable using other forms of therapy.
-
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.
Prescription Use × (Part 21 CFR 801 Subpart D) 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, Office of Device Evaluation (ODE)
(Divisi Sign-Off)
Divisio of General, Restorative,
and Ne .. ological Devices
$10(k) Number.