(53 days)
Not Found
Not Found
No
The document describes a physical medical device (femoral heads) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a component of a hip replacement prosthesis, which is a medical device used to restore joint function rather than directly providing therapy.
No
Explanation: This device, an Ortho Development Ceramic Femoral Head, is intended for use in hip arthroplasty applications. It is a prosthetic implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states "Ortho Development Ceramic Femoral Heads," indicating a physical hardware component (ceramic femoral heads) is the device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device described is a "Ceramic Femoral Head," which is a component of a hip implant used in surgery.
- Intended Use: The intended use clearly states it's for "hip arthroplasty applications" and lists conditions related to the hip joint itself, not analysis of bodily fluids or tissues.
This device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for use with a cemented 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 1. 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 turnors, 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 U.S. Department of Health and Human Services. The logo features a stylized depiction of three human figures connected together, representing health and human services. The figures are arranged in a row, with their heads slightly overlapping. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AFR 2 x 2006
Ortho Development Corporation c/o Mr. William J. Griffin Regulatory and Clinical Affairs Manager 12187 South Business Park Drive Draper. Utah 84020
Re: K060577
Trade/Device Name: Ortho Development Ceramic Femoral Heads 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 2, 2006 Received: March 6, 2006
Dear Mr. Griffin:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices is classified (see above) into either class II (Special Controls) or class III (PMA). they 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 devices comply 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 devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification 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 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 vours,
Hichel Lemur as
· Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Ortho Development - 510(k) Ceramic Femoral Heads with CoCr Cemented Femoral Stems
Indications for Use
KC60577 510(k) Number (if known):
Device Name: Ortho Development Ceramic Femoral Heads
Indications for Use
The device is intended for use with a cemented 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 1. 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 turnors, 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 of General, Restorative. and Neurological Devices
510(k) Number kV60577