(28 days)
Not Found
No
The device description and intended use are purely mechanical, describing a ceramic component for hip replacement. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a femoral head component used in total hip arthroplasty to replace a damaged hip joint, which is a therapeutic intervention aimed at increasing patient mobility and reducing pain.
No
The device is a component of a total hip replacement, used to replace a damaged hip joint, not to diagnose a condition.
No
The device description clearly states it is a physical component (femoral head) made of an alumina composite material, intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The DePuy Ceramic Femoral Head is a physical implant designed to replace the damaged femoral head in a total hip arthroplasty procedure. It is used in vivo (within the body) as a component of a surgical procedure.
- Lack of Specimen Examination: The device does not examine any specimens from the human body. Its function is mechanical and structural within the hip joint.
Therefore, based on the provided information, the DePuy Ceramic Femoral Head clearly falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
Product codes (comma separated list FDA assigned to the subject device)
87 LZO
Device Description
The DePuy Ceramic Femoral Head is composed of an alumina composite material and is available in a 36mm head diameter with a +12-offset option. The internal bore of the ceramic femoral head, which is designed to interlock with the external taper on the femoral hip stem, is available in a 12/14 Articul/eze taper option.
The ceramic head is designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K040644
page 1 of 2
| NAME OF FIRM: | DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988 |
|---|---|
| 510(k) CONTACT: | Rebecca L. Lennard Project Engineer |
| TRADE NAME: | DePuy Ceramic Femoral Head |
| COMMON NAME: | Ceramic Femoral Ball Prosthesis |
| CLASSIFICATION: | 888.3353: Hip joint femoral metal/ceramic/polymer, semi-constrained cemented or nonporous, uncemented prosthesis; Class II |
| DEVICE PRODUCT CODE: | 87 LZO |
| SUBSTANTIALLY EQUIVALENT DEVICE: | DePuy Ceramic Femoral Heads, K031803 |
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Ceramic Femoral Head is composed of an alumina composite material and is available in a 36mm head diameter with a +12-offset option. The internal bore of the ceramic femoral head, which is designed to interlock with the external taper on the femoral hip stem, is available in a 12/14 Articul/eze taper option.
The ceramic head is designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement.
INDICATIONS FOR USE:
The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
1
BASIS OF SUBSTANTIAL EQUIVALENCE:
DePuy considers the Ceramic Femoral Head to be substantially equivalent to the DePuy Ceramic Femoral Heads submitted in K031803 based on similarities in design, same material composition, same sterilization and packaging methods, same intended use/indications for use, and similar labels.
K040644
page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2004
Ms. Rebecca L. Lennard Project Engineer DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K040644
Trade/Device Name: DePuy Ceramic Femoral Head 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 10, 2004 Received: March 11, 2004
Dear Ms. Lennard:
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.
3
Page 2 - Ms. Rebecca L. Lennard
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 (301) 594-4659. 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,
Mark H. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ KOHO6 H4 Device Name: DePuy Ceramic Femoral Head
Indications for Use:
The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) |
|---|---|---|---|
| ---------------------------------------------- | --- | -------- | --------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices |
(Posted November 13, 2003)
| 510(k) Number | K040644 |
|---|---|
| --------------- | --------- |