(56 days)
No
The document describes a mechanical hip stem and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Total hip arthroplasty" system intended to replace a damaged hip joint, which is a therapeutic intervention aimed at treating a medical condition and improving patient mobility and reducing pain.
No
The device description indicates it is a "collarless, tapered, press-fit femoral stem" for total hip arthroplasty, and its intended use is to replace a damaged hip joint. This classifies it as a therapeutic or prosthetic device, not one used for diagnosis.
No
The device description clearly states it is a physical femoral stem made of wrought stainless steel, which is a hardware component.
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 information clearly describes a surgical implant (a hip stem) intended to be surgically placed inside the patient's body to replace a damaged hip joint. It is a physical component of a total hip prosthesis.
- Lack of IVD Characteristics: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
This device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Total hip arthroplasty is intended to provide increased patient mobility and reduce paint by replacing Total hip arthroplasty is intended in patients where there is evidence of sufficient sound bone to the damaged hip joint articulation in patients where is indicated in the fo the damaged hip joint articulation in patients where is evilence of the following conditions:
seat and support the components. Total hip replacement is indicated in the follo
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Avascular nocrobis of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
- Failed previous hip surgery including joint reconstruction, internent Failed previous mp surgery morading John oplasty, or total hip replacement.
- Certain cases of ankylosis. 5.
The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only.
Product codes
JDI, LZO
Device Description
The C-Stem AMT hip is a collarless, tapered, press-fit femoral stem. It is manufactured from wrought stainless steel (Ortron 90° conforming to ISO 5832-9) and is polished overall. The stem is offered in 7 sizes, with each body size having either a standard or high offset. It may be used with commercially available modular femoral heads, either metal or ceramic, to form the femoral component of a total hip prosthesis. Accessory items include previously cleared cement restrictors and centralizers.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
EC 22 2004
Image /page/0/Picture/2 description: The image shows a logo with a black circle on the left, followed by the letters "D-N" in a stylized font. Below the logo, there is text that reads "a Johnson&Johnson company". The text is smaller and less clear than the logo itself.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 20 October 2004 DATE PREPARED: DePuy Orthopaedics, Inc. SPONSOR OF 510(k): 700 Orthopaedic Drive, Warsaw, IN 46581-0988 Establishment Registration Number: 1818910 Dina L. Weissman, J.D. 510(K) CONTACT: Legal Consultant, Regulatory Affairs Tel: (574) 371-4905, Fax: (574) 371-4987 Email: Dweissma@dpyus.jnj.com DePuy® C-Stem AMT Hip Prosthesis TRADE NAME: Total Hip Joint Replacement Prosthesis COMMON NAME: Class II per CFR 888.3350 (JDI) CLASSIFICATION: Hip joint metal/polymer semi-constrained cemented prosthesis Unclassified (LZO) Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous, uncemented 87JDI or 87LZO DEVICE PRODUCT CODE: C-stem (K982918) cleared October 12, 1998 SUBSTANTIALLY
DEVICE DESCRIPTION:
EQUIVALENT DEVICES:
The C-Stem AMT hip is a collarless, tapered, press-fit femoral stem. It is manufactured from wrought stainless steel (Ortron 90° conforming to ISO 5832-9) and is polished overall. The stem is offered in 7 sizes, with each body size having either a standard or high offset. It may be used with commercially available modular femoral heads, either metal or ceramic, to form the femoral component of a total hip prosthesis. Accessory items include previously cleared cement restrictors and centralizers.
Titan hip (K001991) cleared August 31, 2000
INDICATIONS FOR USE:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where 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, theumatoid arthritis, theumatoid arthritis, or congenital ﺎﺕ ﺍﻟﻤﺴﺘﺸﻔﻴﺎﺕ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﺎﺑﺎﺕ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﺎﺑﺎﺕ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﺎﺑﺎﺕ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤ hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface 4. replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
- The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only.
SUBSTANTIAL EQUIVALENCE:
Neither the intended use nor the fundamental scientific technologies of the DePuy" C-Stem AMT have changed from the legally marketed predicate devices, the DePuy Titan Porocoat® Hip Prosthesis (K001991) and the DePuy C-Stem System (K982918). They have the same material, intended use, indication method, packaging and method of manufacture. The design, while not identical to the predicates, does not raise of safety or effectiveness. DePuy believes that the DePuy C-Stem AMT is substantially equivalent to these two previously cleared devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2004
Ms. Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K042959
Trade/Device Name: C-Stem AMT Hip Prosthesis Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI, LZO Dated: November 19, 2004 Received: November 22, 2004
Dear Ms. Weissman:
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.
2
Page 2 - Dina L. Weissman, J.D.
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,
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
3
Indications for Use
510(k) Number (if known): _Ko4 1959 510(R) Name: DePuy® C-Stem AMT Hip Stem
Indications for Use:
Total hip arthroplasty is intended to provide increased patient mobility and reduce paint by replacing Total hip arthroplasty is intended in patients where there is evidence of sufficient sound bone to
the damaged hip joint articulation in patients where is indicated in the fo the damaged hip joint articulation in patients where is evilence of the following conditions:
seat and support the components. Total hip replacement is indicated in the follo
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Avascular nocrobis of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
- Failed previous hip surgery including joint reconstruction, internent Failed previous mp surgery morading John oplasty, or total hip replacement.
- Certain cases of ankylosis. 5.
The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only.
Prescription Use XXXXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Allen Witte
(Division Sign-Off) (Division of General, Restorative, Divisions Neurological Devices
510(k) Number K042955