(21 days)
Not Found
No
The document describes a physical medical device (acetabular liners) and its intended use and performance testing, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is a medical implant (acetabular liner) used in total hip replacement to restore joint function and alleviate painful, disabling joint disease, which are therapeutic interventions.
No
This device is a total hip replacement component (acetabular liner) intended for surgical implantation, not for diagnosing medical conditions.
No
The device description clearly indicates the device is a physical acetabular liner made of polyethylene, intended for mechanical assembly in hip replacement surgery. It is a hardware component, not software.
No, 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 in the body, not a device used to test samples outside the body.
- Device Description: The description details the physical characteristics of the acetabular liners, which are components of a hip implant.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
This device is a surgical implant used in orthopedic procedures.
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, theumatoid . 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
87 LPH
Device Description
The existing Trident® Polyethylene Acetabular System features acetabular liners in neutral, hooded, eccentric and elevated rim versions. The subject Trident® Crossfire® Polyethylene Liners are an addition to the existing liners (standard and eccentric versions). The subject liners will be offered in fourteen new sizes which include the addition of a 36mm size eccentric liner in both 0° and 10° versions and 26mm, 28mm, 32mm and 36mm size standard liners in both 0° and 10° versions in the same polyethylene thicknesses as the Trident® Elevated Rim Liners. The subject liners, like the predicate liners, are manufactured using Crossfire® polyethylene.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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 new liner sizes in the subject series to the predicate devices.
Key Metrics
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Predicate Device(s)
Osteonics® Secur-FitTM AD Generation II Acetabular Component System, Osteonics® Trident® Polyethylene Inserts, Line Extension, Trident® Elevated Rim Liners
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
Kozia 11
Line Extension to the Trident® Polyethylene Acetabular System – Trident® Crossfire® Polyethylene Liners
Special 510(k) Premarket Notification
Special 510(k) Summary
Line Extension to the Trident® Polyethylene Acetabular System - Trident® Crossfire® Polyethylene Liners
| Proprietary Name: | Trident® Crossfire® Polyethylene Liners |
|---|---|
| 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-FitTM AD Generation II |
| Acetabular Component System; Line Extension | |
| Osteonics® Trident® Polyethylene Inserts; and | |
| Line Extension, Trident® Elevated Rim Liners | |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code(s): | 87 LPH and LZO |
| For Information Contact: | Debra Bing |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, New Jersey 07401-1677 | |
| Phone: (201) 831-5413 | |
| Fax: (201) 831-6038 |
Description/Technological Comparison
The existing Trident® Polyethylene Acetabular System features acetabular liners in neutral, hooded, eccentric and elevated rim versions. The subject Trident® Crossfire® Polyethylene Liners are an addition to the existing liners (standard and eccentric versions). The subject liners will be offered in fourteen new sizes which include the addition of a 36mm size eccentric liner in Page 3
1
Line Extension to the Trident® Polyethylene Acetabular System -- Trident® Crossfire® Polyethylene Liners
both 0° and 10° versions and 26mm, 28mm, 32mm and 36mm size standard liners in both 0° and 10° versions in the same polyethylene thicknesses as the Trident® Elevated Rim Liners. 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, theumatoid . 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 new liner sizes in the subject series to the predicate devices.
2
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Image /page/2/Picture/2 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 with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 : :
Mr. William J. Cymbaluk Vice President Quality Assurance, Regulatory Affairs and Clinical Research Stryker Howmedica Osteonics Corporation 59 Route 17 South Allendale, NJ 07401
Re: K021911
Trade Name: Trident® Crossfire® Polyethylene Liners 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: June 7, 2002 Received: June 11, 2002
Dear Mr. Cymbaluk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (OS) 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 - Mr. William J. Cymbaluk
and the country of the first to
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" (21CFR 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,
L. Colin M. Wittwer, Ph.D., M.D.
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 Z ( G | l
Device Name: Line Extension to the Trident® Polyethylene Acetabular System-Trident® Crossfire® Polyethylene 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, theumatoid . 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
Hyte Rhodes
Division/Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021911