(87 days)
Not Found
No
The document describes a mechanical hip prosthesis and its intended use, with no mention of AI or ML technology in the device description, intended use, or any other section.
Yes
The device is a total hip arthroplasty system, which is a medical implant intended to replace a damaged hip joint, thereby relieving pain and increasing mobility. This aligns with the definition of a therapeutic device as it directly treats a condition (damaged hip joint) to improve a patient's health.
No
The device described is a total hip arthroplasty system, which is an orthopedic implant used for joint replacement, not for diagnosing medical conditions. Its intended use is to replace a damaged hip joint, not to provide diagnostic information.
No
The device description clearly states it is a "three-piece, uncemented femoral hip prosthesis consisting of a proximal body, a distal stem and a locking nut," which are physical hardware components.
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.
- Device Description: The provided description clearly states that this device is a femoral hip prosthesis, which is an implantable device used in surgery to replace a damaged hip joint.
- Intended Use: The intended use describes a surgical procedure (total hip arthroplasty) to replace a joint, not to perform tests on bodily samples.
Therefore, based on the provided information, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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 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, rheumatoid 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.
This device is intended for single use.
Product codes
87LPH
Device Description
The Spectrum Modular System is a three-piece, uncemented femoral hip prosthesis consisting of a proximal body, a distal stem and a locking nut. The proximal bodies and distal stems are interchangeable, allowing each to be independently positioned. They are available in a variety of proximal body lengths, distal body diameters and lengths.
Mentions image processing
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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)
K001991, K001660, K992667, K955296
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
K033893 page 17
MAR 1 2 2004
510(k) Summary
| Name of Sponsor: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) Contact: | Dina L. Weissman, J.D.
Legal Consultant, Regulatory Affairs
Phone: (574) 371-4905
FAX: (574) 371-4987
Email: Dweissma@dpyus.jnj.com | |
| Trade Name: | Spectrum Modular System | |
| Common Name: | Femoral Hip Joint Uncemented Prosthesis | |
| Classification: | Class II device per 21 CFR 888.3358:
Hip joint metal/polymer semi-constrained
uncemented prosthesis | |
| Device Product Code: | 87LPH Hip joint metal/polymer semi-
constrained uncemented prosthesis | |
| | No performance standards have been established
under Section 514 of the Federal Food, Drug,
and Cosmetic Act for femoral hip stems. | |
| Substantially Equivalent Devices: | Titan Porocoat Hip Prosthesis | K001991 |
| | Malory Head Modular Calcar | K001660 |
| | ZMR Hip System Revision Taper | K992667 |
| | Link Mp Reconstruction Hip | K955296 |
| Device Descriptions: | The Spectrum Modular System is a three-piece,
uncemented femoral hip prosthesis consisting of
a proximal body, a distal stem and a locking nut.
The proximal bodies and distal stems are
interchangeable, allowing each to be
independently positioned. They are available in
a variety of proximal body lengths, distal body
diameters and lengths. The system is | |
1
510(k) Summary (continued)
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 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, rheumatoid 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, surface hemiarthroplasty, and arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
Substantial equivalence:
The Spectrum Modular System uncemented femoral hip prosthesis has the same intended use and basic design as the predicate devices and is therefore substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diana L. Weissman, J.D. Depuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Drive Warsaw, Indiana 46581-0988
Re: K033893 Trade/Device Name: Spectrum Modular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: December 15, 2003 Received: December 16, 2003
MAR 1 2 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.
3
Page 2 - Ms. Diana 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 (301) 594-4639. 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 may be obtained 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 vours.
Sincerely yours,
L. Mark A. McMillan
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
510(k) Number (if known): Ko 3 S89 3
Device Name: Spectrum Modular System
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 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, rheumatoid 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.
This device is intended for single use.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General, R. storative, and Neurological Devices
510(k) Number K033893