(87 days)
Not Found
No
The device description and intended use focus solely on the physical characteristics and mechanical function of an acetabular shell for hip replacement. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is an acetabular shell used in hip replacement surgery, which is a therapeutic intervention for painful and disabling joint disease.
No
The device is an orthopedic implant (acetabular shell) intended for surgical replacement in hip joint disease, not for diagnostic purposes.
No
The device description clearly details physical components made of Ti6Al4V alloy and CP Titanium, with specific geometries and features like screw holes and a dome hole. This indicates a hardware device, not software only.
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 "cemented or cementless fixation within the prepared acetabulum" and for use with "mating Trident Polyethylene Cup Inserts." This describes a surgical implant used in vivo (within the body) to treat painful hip joint disease.
- Device Description: The description details the physical characteristics of the acetabular shells, including material, geometry, screw hole configurations, and size. These are all features of a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The subject Trident Acetabular Shells are single-use devices intended for cemented or cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts.
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 unsuccessful 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)
LZO
Device Description
The subject Trident Acetabular Shells are characterized by the following features:
- Shell substrate: Ti6Al4V alloy.
- Surface coating: a rough layer of plasina-sprayed CP Titanium.
- Outer Shell Geometry: The subject series of Trident Acetabular Shells will include one version with the patented Dual Radius (PSL®) outer geometry and one version with a single-radius (hemispherical) outer geometry:
- Inner Shell Geometry: An interior geometry which accommodates the predicate Trident Polyethylene Acetabular Insert through a wireless locking mechanism..
- Apical Dome Hole: This dome hole (which is not intended to receive a bone screw) is featured on all subject shell versions, and allows for attachment of the shell to implantation/removal instrumentation.
- Screw Hole Configurations: The subject shells are available in any of the following screw hole configurations:
- Solid Back: No Screw Holes. -
- 3-Hole: Three screw holes clustered on the dome of the shell. -
- 5-Hole: Five screw holes clustered on the dome of the shell. -
- Multi-cluster: A number of screw holes (ranging from 4 to 16, depending on shell size) scattered across the dome of the shell.
- X'tra Solid Back: Features screw holes around the periphery of the shell, but no dome screw holes.
- X'tra Multi-cluster: Features screw holes around the periphery of the shell, and a number of screw holes (ranging from 4 to 16, depending on shell size) scattered across the dome of the shell.
- A range of outer diameter (O.D.) sizes from 40 through 80mm, in 2mm increments
In addition, the following design feature is exclusive to the Dual Radius (PSL®) versions of the subject devices: - Circumferential Normalizations: Normalizations are distinct steps which are machined into the exterior of the shells. The circumferential normalizations on the subject shells begin at the peripheral lip and progress approximately one third of the way up the face of the shells, decreasing gradually until the step profile is negated by the PS coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, acetabulum
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)
Test data characterizing the plasma-sprayed Titanium coating was provided in accordance with relevant FDA guidance documents. The shell-to-insert locking mechanism was tested to characterize fatigue strength, push-out resistance, and lever-out torque resistance. (All test data was incorporated by reference to previous 510(k)s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K983502, K971854, K933102, K972893
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.
Not Found
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
4 2000 AUG
510(k) Summary
Name and Address of the Sponsor:
Howmedica Osteonics Corp.
59 Route 17
May 4, 2000
Allendale, NJ 07401-1677
Trident Acetabular Shells: PS
Terry Sheridan Powell
Date of Summary Preparation:
Proprietary Name:
Contact Person:
Common Name:
Classification Name and Reference:
Artificial Hip Replacement Components -
Acetabular
Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented or Non-Porous Uncemented Prosthesis 21 CFR §888.3353
Predicate Device Identification
- Trident Acetabular Shells (K983502 originally called the "Osteonics Secur-Fit AD . Generation II Acetabular Component System")
- Osteolock NP and Osteolock Cluster Acetabular Shells (K971854-and K933102)
- Partnership Revision Femoral Components (K972893)
Device Description
The subject Trident Acetabular Shells are characterized by the following features:
- Shell substrate: Ti6Al4V alloy.
- Surface coating: a rough layer of plasina-sprayed CP Titanium.
- Outer Shell Geometry: The subject series of Trident Acetabular Shells will include one version with the patented Dual Radius (PSL®) outer geometry and one version with a
1
single-radius (hemispherical) outer geometry:
- Inner Shell Geometry: An interior geometry which accommodates the predicate Trident Polyethylene Acetabular Insert through a wireless locking mechanism..
- Apical Dome Hole: This dome hole (which is not intended to receive a bone screw) is featured on all subject shell versions, and allows for attachment of the shell to implantation/removal instrumentation.
- Screw Hole Configurations: The subject shells are available in any of the following screw hole configurations:
- Solid Back: No Screw Holes. -
- 3-Hole: Three screw holes clustered on the dome of the shell. -
- 5-Hole: Five screw holes clustered on the dome of the shell. -
- Multi-cluster: A number of screw holes (ranging from 4 to 16, depending on shell size) scattered across the dome of the shell.
- X'tra Solid Back: Features screw holes around the periphery of the shell, but no dome screw holes.
- X'tra Multi-cluster: Features screw holes around the periphery of the shell, and a number of screw holes (ranging from 4 to 16, depending on shell size) scattered across the dome of the shell.
- A range of outer diameter (O.D.) sizes from 40 through 80mm, in 2mm increments
In addition, the following design feature is exclusive to the Dual Radius (PSL®) versions of the subject devices:
- Circumferential Normalizations: Normalizations are distinct steps which are machined into the exterior of the shells. The circumferential normalizations on the subject shells
2
begin at the peripheral lip and progress approximately one third of the way up the face of the shells, decreasing gradually until the step profile is negated by the PS coating.
Intended Use:
The Trident Acetabular Shells described in this 510(k) submission are single-use devices intended for cemented or cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts.
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 unsuccessful 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.
3
Statement of Technological Comparison:
Materials
The subject Trident Acetabular Shells feature the same substrate material as the predicate Trident Acetabular Shells (Ti6A14V ELI alloy). The subject Trident Acetabular Shells feature the same plasma-sprayed Titanium coating featured on the predicate Partnership Revision Femoral Components (K972893).
Indications for Use
The subject Trident Acetabular Shells have the same indications for use as the predicate Trident Acetabular Shells.
Design
The subject Trident Acetabular Shells combine design elements that have long been employed in other commercially-available acetabular shell designs. The specific combination of design features employed in the subject Trident Acetabular Shells do not raise any new questions of safety or effectiveness.
Performance Data:
Test data characterizing the plasma-sprayed Titanium coating was provided in accordance with relevant FDA guidance documents. The shell-to-insert locking mechanism was tested to characterize fatigue strength, push-out resistance, and lever-out torque resistance. (All test data was incorporated by reference to previous 510(k)s).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 2000
Ms. Terry Sheridan Powell Regulatory Affairs Team Member Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K001449
Trade Name: Trident Acetabular Shells: PS Regulatory Class: II Product Code: LZO Dated: May 4, 2000 Received: May 9, 2000
Dear Ms. Powell:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Ms. Terry Sheridan Powell
This letter will allow you to begin marketing your device as described in your 510(k) rms reter 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Dune R. Lochner.
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
6
510(k) Number (if known): KOOI449
Device Name: Trident Acetabular Shells: PS
Indications For Use:
The subject Trident Acetabular Shells are single-use devices intended for cemented or cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts.
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 unsuccessful 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)
pinne Duma (Division Si n-Off) Division of eneral Restorative Devices 510(k) Number KOO 1449
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Per 21 CFR 801.109)