(83 days)
No
The document describes a ceramic femoral head, a mechanical component of a hip replacement system. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML.
Yes
The device is a component of a hip system intended to restore patient mobility, which is a therapeutic function for medical conditions like arthritis and fractures.
No
The provided text describes an implantable medical device, a ceramic femoral head, used in hip replacement surgery. It is a device intended for treatment and restoration of function, not for diagnosing a condition.
No
The device description clearly states it is a "Ceramic Femoral Head," which is a physical hardware component for a hip replacement system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a ceramic femoral head) that is intended for cemented implantation during primary/revision surgery to restore patient mobility. This device is placed inside the body.
The information provided about the device's intended use, indications, and description all point to it being a surgical implant, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Headloc™ Ceramic Femoral Head for the Primaloc™ Cemented Hip System is intended for single-use cemented implantation during primaryrevision surgery. The ceramic head allows for primary articulation between the acetabular cup and femoral stem to restore patient mobility. Indications for use are:
- Osteoarthritis, rheumatoid arthritis, or other osteoarthroses;
- Certain femoral neck fractures or dislocations;
- Post-traumatic arthritis;
- Idiopathic avascular necrosis of the femoral head;
- Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis;
- Previous failed surgery;
- Total hip replacement where the surgeon indicates a ceramic head
The Headloc™ Ceramic Head may be used with the Primaloc™ Cemeted Hip System which is cleared for use under Premarket Notification K962448.
Product codes
LZO
Device Description
Headloc™ Ceramic Femoral Head
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head, acetabular cup
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 is a circular seal for the Department of Health & Human Services USA. The seal features the department's name encircling an emblem. The emblem is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol J. Freasier Regulatory Affairs/Quality Assurance Specialist Ortho Development Corporation 106 West Business Park Drive Draper, Utah 84020
K971426 Re : Headloc™ Zirconia Ceramic Heads Regulatory Class: II JUL - 9 1997 Product Code: LZO Dated: April 16, 1997 Received: April 18, 1997
Dear Ms. Freasier:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the zirconia Headlor™ Ceramic Femoral Heads are to be used only with CoCrMo or Ti6Al4V alloy hip stems with the CeramTec 2°52'30" Morse taper trunnions.
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.
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Page 2 - Ms. Carol J. Freasier
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895: A~ : : substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
2
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Ortho Development Corporation Premarket Notification for Headloc™ Ceramic Femoral Heads 510(k) Number (if known): K97 1435
Device Name: Headloc™Ceramic Femoral Head
Indications for Use
The Headloc™ Ceramic Femoral Head for the Primaloc™ Cemented Hip System is intended for single-use cemented implantation during primaryrevision surgery. The ceramic head allows for primary articulation between the acetabular cup and femoral stem to restore patient mobility. Indications for use are:
- Osteoarthritis, rheumatoid arthritis, or other osteoarthroses;
- Certain femoral neck fractures or dislocations;
- Post-traumatic arthritis;
- Idiopathic avascular necrosis of the femoral head;
- Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis;
- Previous failed surgery;
- Total hip replacement where the surgeon indicates a ceramic head
The Headloc™ Ceramic Head may be used with the Primaloc™ Cemeted Hip System which is cleared for use under Premarket Notification K962448.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971426 |
| Prescription Use | X |
|---|---|
| ------------------ | ---------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)