(84 days)
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No
The provided text does not contain any mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use and indications for a femoral stem.
Yes
The device is intended for hip arthroplasty applications to treat impaired hip joints due to various conditions like arthritis, fractures, and bone tumors, which are therapeutic interventions.
No
The provided text describes the intended use of a device for hip arthroplasty applications, specifically an uncemented press-fit femoral stem, which is a therapeutic device (an implant). It does not mention any function related to diagnosing a disease or condition. Its purpose is to treat conditions like osteoarthritis or fractures, not identify them.
No
The provided text only describes the intended use and indications for use of a medical device, which is a femoral stem (a hardware implant). It does not provide any information about the device's description, particularly whether it is software or hardware.
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 used in hip arthroplasty (joint replacement surgery). This is a surgical procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not fit that description.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, laboratory procedures, or diagnostic testing.
Therefore, this device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for use with an uncemented press-fit femoral stem. The device is intended for use in hip arthroplasty applications whose indications include:
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia.
- 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.
Product codes
LZO
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 neck
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circle around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1414 17 2008
Ortho Development Corporation c/o Mr. William J. Griffin Regulatory and Clinical Affairs Manager 12187 South Business Park Drive Draper, Utah 84020
Re: K053587
Trade/Device Name: Ortho Development Ceramic Femoral Heads with Press-fit Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: March 1, 2006 Received: March 2, 2006
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 interstatc 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, FIJA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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
1
Page 2 – Mr. William J. Griffin
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) 276-0120. 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/dsma/dsmamain.html
Sincerely yours,
Herbert Semmel
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
| 510(k) Number (if known): | K053587 |
|---|---|
| Device Name: | Ortho Development Ceramic Femoral Heads with Press-fit Stems |
ﺤﻤﺪ
Indications for Use
The device is intended for use with an uncemented press-fit femoral stem. The device is intended for use in hip arthroplasty applications whose indications include:
-
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic arthritis, protrusion acetabuli and painful hip dysplasia.
-
- Previously failed surgery.
- Proximal femoral neck fractures or dislocation. 3.
-
- 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)
(Division Si-Off)
Division of Ceneral, Restorative,
and Neurological Devices
510(k) Number K053581