(74 days)
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Not Found
No
The device description focuses solely on the material, design, and mechanical features of a hip replacement component, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an acetabular component intended for use in treating osteoarthritis, rheumatoid arthritis, and traumatic arthritis, which are medical conditions, and it is a permanent implant.
No
The device description outlines a manufactured component (acetabular component) intended for surgical implantation to treat arthritis, and its function is to replace a joint, not to diagnose a condition.
No
The device description clearly details a physical implant (acetabular component) made of specific materials and with various physical features (sizes, coatings, pins, screw holes, polyethylene inserts). This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is an "HHS Acetabular Component," which is a component of a hip replacement implant. It is a physical device implanted into the body.
- Intended Use: The intended use is for treating osteoarthritis, rheumatoid arthritis, and traumatic arthritis by replacing the hip joint. This is a surgical procedure, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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- Ostcoarthritis
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- Rheumatoid Arthritis
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- Traumatic Arthritis
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- Where the use of a more conservative procedure has failed or is unacceptable.
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- Intended for non-comented use, single use only
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The Signal Medical Corporation HHS Acetabular Component is manufactured of ASTM I-136 or F-75. The design is made available in twelve (12) sizes ranging from 48mm to 70mm, in two mm increments. The cup is coated with an F-67 sintered beaded surface for F-136 or F-75 beads for an F-75 cup to enhance bone ingrowth. The device is designed in three models, one with three circumferentially spaced pins or spikes at 120 degree intervals to provide for a primary skeletal fixation and reduce the chance of rotation, one with screw holes and one with both screw holes and spikes. The ultra high molecular weight polyethylene inserts, ASTM F648, are secured to the acetabular shell using a crown-taper fit. They are designed to accept 28mm femoral heads on their inside diameter from 48mm to 70mm and 32mm femoral heads from 54mm to 70mm. This device is intended for single use only.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip joint
Indicated Patient Age Range
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
§ 888.3358 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
OCT 0 4 2002
KO22382
510K SUMMARY OF SAFETY AND EFFECTIVENESS
The Signal Medical Corporation HHS Acetabular Component is manufactured of ASTM I-136 or F-75. The design is made available in twelve (12) sizes ranging from 48mm to 70mm, in two mm increments. The cup is coated with an F-67 sintered beaded surface for F-136 or F-75 beads for an F-75 cup to enhance bone ingrowth. The device is designed in three models, one with three circumferentially spaced pins or spikes at 120 degree intervals to provide for a primary skeletal fixation and reduce the chance of rotation, one with screw holes and one with both screw holes and spikes. The ultra high molecular weight polyethylene inserts, ASTM F648, are secured to the acetabular shell using a crown-taper fit. They are designed to accept 28mm femoral heads on their inside diameter from 48mm to 70mm and 32mm femoral heads from 54mm to 70mm. This device is intended for single use only.
Indications for use
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- Ostcoarthritis
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- Rheumatoid Arthritis
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- Traumatic Arthritis
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- Where the use of a more conservative procedure has failed or is unacceptable.
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- Intended for non-comented use, single use only
Contact Information
If further information is required, please contact Dr. Louis Serafin, Signal Medical Corporation, 3777 Lapeer Road Suite 3C, Port Huron, Michigan 48060, phone (810) 966-3917.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 04 2002
Louis A. Serafin, Jr., M.D. President Signal Medical Corporation 3777 Lapeer Road 3-C Port Huron, Michigan 48060
Re: K022382
Trade/Device Name: HHS Acetabular Component Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: July 15, 2002
Received: July 22, 2002
Dear Dr. Serafin:
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 - Dr. Louis A. Serafin, Jr.
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 and additionally 21 CFR Part 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 vour 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 Part 807.97). 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.
O Mark A. Millerson
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
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Page ી
STORE MURIDOr (IT Knownly: (If Knowni):
De William Mannes HHS ACETABULAR HIP COMPONENT
undlications For Used
OSTEOARTHRITIS
RHEUMATOID ARTHRITIS
TRAUMATIC ARTHRITIS
WHERE THE USE OF A MORE CONSERVATIVE PROCEDURE HAS FAILED OR IS UNACCEPTABLE
INTENDED FOR NON-CEMENTED USE SINGLE USE ONLY
threase Do not maile retom this time-communiti on amount of Justing a Belliony ro
Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
---|---|---|
for Mark N. Millerson | ||
(Division Sign-Off) | ||
Division of General, Restorative and Neurological Devices | ||
510(k) Number | K022382 | |
Prescription Use | OR | Over-The- |
Counter Use | ||
(Per 21 CFR 801.109) |
(Optional Format