(18 days)
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No
The document describes a mechanical medical device (acetabular liners) and its intended use, materials, and performance testing. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is an acetabular liner for total hip replacement, which is a medical procedure aimed at treating painful and disabling joint disease, clearly indicating a therapeutic purpose.
No
The device is an acetabular liner for total hip replacement, which is a therapeutic device, not one used for diagnosis.
No
The device description clearly indicates it is a physical acetabular liner made of polyethylene, intended for mechanical assembly in hip replacement surgery. It is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "total hip replacement" and "mechanical assembly to predicate Trident® series acetabular shells." This describes a surgical implant used within the body.
- Device Description: The description details a physical implantable component ("acetabular liners") made of polyethylene, designed to be part of a hip replacement system.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
Product codes (comma separated list FDA assigned to the subject device)
87 LPH
Device Description
The existing Trident® Acetabular System features acetabular liners in neutral, hooded and eccentric versions. The subject Trident® Elevated Rim Liners are an addition to the existing liners. They feature an elevated superior rim. The elevated rim is intended to provide added resistance to dislocation during high flexion/adduction angles. The subject liners will also be offered in five new sizes. The subject liners, like the predicate liners, are manufactured using Crossfire® polyethylene.
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
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis was employed to ensure that the risk of cam-out for the subject device is less than the risk associated with predicate devices. Hip wear simulator testing of a similar cup liner was used to demonstrate the comparable safety and effectiveness of the thinner liners in the subiect series to the predicate devices.
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).
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§ 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.
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K020497
1 OF=2
Line Extension to the Trident® Acetabular System - Trident® Elevated Rim Liners
Special 510(k) Premarket Notification
Special 510(k) Summary
Line Extension to the Trident® Acetabular System - Trident® Elevated Rim Liners
| Proprietary Name: | Trident® Elevated Rim Liner |
|---|---|
| Common Name: | Artificial Hip Components |
| Classification Name and Reference: | Hip joint, metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, 21 CFR §888.3358 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 LPH |
| Predicate Proprietary Name(s): | Osteonics® Secur-Fit™ AD Generation II |
| Acetabular Component System; and | |
| Line Extension, Osteonics® Trident® Polyethylene | |
| Inserts | |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code(s): | 87 LPH and LZO |
| For Information contact: | Nancy J. Rieder |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale New Jersey 07401-1677 |
Description/Technological Comparison
The existing Trident® Acetabular System features acetabular liners in neutral, hooded and eccentric versions. The subject Trident® Elevated Rim Liners are an addition to the existing liners. They feature an elevated superior rim. The elevated rim is intended to provide added
Phone: (201) 934-4364 Fax: (201) 760-8435
Page 1
1
Special 510(k) Premarket Notification
resistance to dislocation during high flexion/adduction angles. The subject liners will also be offered in five new sizes. The subject liners, like the predicate liners, are manufactured using Crossfire® polyethylene.
Intended Use
The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are ● less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
Testing Summary
Engineering analysis was employed to ensure that the risk of cam-out for the subject device is less than the risk associated with predicate devices. Hip wear simulator testing of a similar cup liner was used to demonstrate the comparable safety and effectiveness of the thinner liners in the subiect series to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
MAR 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Elizabeth A. Staub Vice President Quality Assurance, Regulatory Affairs and Clinical Research Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677
Re: K020497
Trade/Device Name: Trident Elevated Rim Liner 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: February 12, 2002 Received: February 14, 2002
Dear Ms. Staub:
We have reviewed your Section 510(k) premarket notification of intent to market the device wforders forlowed your been wind 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). and Coometer for ( 10) the 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.
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Page 2 - Ms. Elizabeth Staub
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 your 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 yours.
to 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
4
510(k) Number (if known): KO204977
Device Name: Line Extension to the Trident® Acetabular System-Trident® Elevated Rim Liners
The subject acetabular liners are single-use devices intended for use in total hip replacement. They are intended for mechanical assembly to predicate Trident® series acetabular shells. (The predicate Trident® series shells are intended for cementless fixation.)
Indications:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid ● arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- arminis, post-tradinatio artists, or twad replacement, cup arthroplasty or other procedure. .
- revision of provisions imited issues where arthrodesis or alternative reconstructive techniques are less . likely to achieve satisfactory results.
- Inkery to demove stickly of poor quality or is inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use
Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
Mark A. Mullaney
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number -