(22 days)
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a femoral stem used in total hip arthroplasty to treat severely painful and/or disabled joints, avascular necrosis, fractures, and failed previous surgeries, which are all therapeutic interventions.
No
The device description indicates it is a "collarless, tapered, cemented femoral stem" used as part of a total hip prosthesis, which is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "collarless, tapered, cemented femoral stem," which is a physical implant, not software.
Based on the provided information, the DePuy C-Stem AMT is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to treat hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (femoral stem) used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The DePuy C-Stem AMT is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Indications:
The DePuy C-Stem AMT is indicated for cemented use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia;
-
- Avascular necrosis of the femoral head;
-
- Acute traumatic fracture of the femoral head or neck;
-
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
Intended Use:
The subject C-Stem AMT is intended for cemented use as part of the femoral component in a total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
KWA, JDI, LZO, LPH
Device Description
The C-Stem AMT hip is a collarless, tapered, cemented femoral stem. It may be used with commercially available modular femoral heads, either metal or ceramic, to form the femoral component of a total hip prosthesis to articulate against either a metal or poly insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, femoral neck
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.
DePuy C-Stem AMT, K042959
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
510 (k) Summary
AUG 2 9 2008
(As required by 21 CFR 807.92 and 21 CFR 807.93)
NAME OF SPONSOR:
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910
Electronic Mail: Rinver7(@dpyus.jnj.com
510(K) CONTACT:
DATE PREPARED: PROPRIETARY NAME: COMMON NAME: CLASSIFICATION:
July 24, 2008
Rhonda Myer
DePuy C-Stem AMT
Cemented hip stem prosthesis
Regulatory Affairs Associatc Telephone: (574) 371-4927 Facsimile: (574) 371-4987
Class III per 21 CFR 888.3330: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (KWA)
Class II per 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis (JDI)
Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (LZO)
Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis (LPH)
DEVICE PRODUCT CODE:
87 KWA, JDI, LZO, LPH
SUBSTANTIALLY EQUIVALENT DEVICE:
DePuy C-Stem AMT, K042959
DEVICE DESCRIPTION:
The C-Stem AMT hip is a collarless, tapered, cemented femoral stem. It may be used with commercially available modular femoral heads, either metal or ceramic, to form the
1
K0822J39 #d/d
femoral component of a total hip prosthesis to articulate against either a metal or poly insert.
INDICATIONS AND INTENDED USE:
Indications:
The DePuy C-Stem AMT is indicated for cemented use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia;
-
- Avascular necrosis of the femoral head;
-
- Acute traumatic fracture of the femoral head or neck;
-
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
Intended Use:
The subject C-Stem AMT is intended for cemented use as part of the femoral component in a total hip arthroplasty.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject C-Stem AMT is substantially equivalent to the previously cleared DePuy C-Stem AMT, K042959.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black and white, and the text is in a simple sans-serif font. The logo is simple and recognizable.
AUG 2 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs Associate P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K082239
Trade/Device Name: DePuy C-Stem AMT Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, JDI, LZO, LPH Dated: August 6, 2008 Received: August 7, 2008
Dear Ms. Myer:
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
3
Page 2 - Ms. Rhonda Myer
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K082239 510 (k) Number (if known):
Device Name: DePuy C-Stem AMT
Indications for Use:
The DePuy C-Stem AMT is indicated for cemented use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia;
-
- Avascular necrosis of the femoral head;
-
- Acute traumatic fracture of the femoral head or neck;
-
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Mark N. Mckee Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number