K Number
K001448
Device Name
TRIDENT ACETABULAR SHELLS: PS-HA
Date Cleared
2000-08-04

(87 days)

Product Code
Regulation Number
888.3353
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The subject Trident Acetabular Shells are single-use devices intended for 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.
Device Description
The subject Trident Acetabular Shells are characterized by the following features: - Shell substrate: Ti6Al4V alloy. . - Surface coating: PS-HA. This coating is comprised of a rough layer of plasma-sprayed . CP Titanium beneath a thin layer of Hydroxylapatite (HA). This coating is similar to the AD-HA coating (a rough layer of arc-deposited CP Titanium beneath a thin layer of HA) featured on the predicate Trident Acetabular Shells , and identical to the coating found on the predicate Citation TMZF HA Hip Stems. - 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 all 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 three fourths of the way up the face of the shells, decreasing gradually until the step profile is negated by the PS-HA coating.
More Information

Not Found

No
The device description focuses on the material properties, geometry, and mechanical features of an acetabular shell for hip replacement. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies described are mechanical tests of the device components.

Yes
The device is an acetabular shell, which is a component of a hip replacement system. Its intended use for relieving painful, disabling joint disease of the hip and revision surgeries clearly indicates its role in treating medical conditions.

No

Explanation: The device is an acetabular shell, which is an implant used in hip replacement surgery. Its intended use is for cementless fixation within the prepared acetabulum for conditions like painful joint disease of the hip, not for diagnostic purposes.

No

The device description clearly details a physical implantable device made of Ti6Al4V alloy with specific geometries, coatings, and screw hole configurations. It is a hardware device, not software.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The intended use clearly states the device is for "cementless fixation within the prepared acetabulum" and for treating painful, disabling joint disease of the hip. This describes a surgical implant used directly in the body, not a device used to examine specimens from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
  • Device Description: The description details the physical characteristics of an implantable device (material, coating, geometry, screw holes, etc.). There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing.
  • Lack of IVD Keywords: The text does not contain keywords commonly associated with IVD devices, such as "in vitro," "specimen," "assay," "reagent," "diagnosis," "testing," "laboratory," etc.

The device described is a surgical implant used in hip replacement procedures.

N/A

Intended Use / Indications for Use

The Trident Acetabular Shells described in this 510(k) submission are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Osteonics Generation II 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)

MEH

Device Description

The subject Trident Acetabular Shells are characterized by the following features:

  • Shell substrate: Ti6Al4V alloy. .
  • Surface coating: PS-HA. This coating is comprised of a rough layer of plasma-sprayed . CP Titanium beneath a thin layer of Hydroxylapatite (HA). This coating is similar to the AD-HA coating (a rough layer of arc-deposited CP Titanium beneath a thin layer of HA) featured on the predicate Trident Acetabular Shells , and identical to the coating found on the predicate Citation TMZF HA Hip Stems.
  • 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 all of the following screw hole configurations:
    • Solid Back: No Screw Holes.
    • 3-Hole: Three screw holes clustered on the dome of the shell. -
    • ﺴﺖ 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 three fourths of the way up the face of the shells, decreasing gradually until the step profile is negated by the PS-HA coating.

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

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 PS-HA 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. (This test data was incorporated by reference to a previous 510(k)).

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.

K983382, K971854, K933102, K993768

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

AUG 4 2000510(k) SummaryK001448
-------------------------------------
Name and Address of the Sponsor:Howmedica Osteonics Corp.
59 Route 17
Allendale, NJ 07401-1677
Contact Person:Terry Sheridan Powell
Date of Summary Preparation:May 4, 2000
Proprietary Name:Trident Acetabular Shells: PS-HA
Common Name:Artificial Hip Replacement Components - Acetabular
Classification Name and Reference:Hip Joint Metal/Ceramic/Polymer
Semi-Constrained Cemented or Non-Porous Uncemented Prosthesis
21 CFR §888.3353

Predicate Device Identification

  • Trident Acetabular Shells (K983382 originally called the "Osteonics HA Generation . II Acetabular Component System")
  • Osteolock NP and Osteolock Cluster Acetabular Shells (K971854 and K933102) .
  • Citation TMZF HA Hip Stems (K993768) .

Device Description

The subject Trident Acetabular Shells are characterized by the following features:

  • Shell substrate: Ti6Al4V alloy. .
  • Surface coating: PS-HA. This coating is comprised of a rough layer of plasma-sprayed . CP Titanium beneath a thin layer of Hydroxylapatite (HA). This coating is similar to

1

the AD-HA coating (a rough layer of arc-deposited CP Titanium beneath a thin layer of HA) featured on the predicate Trident Acetabular Shells , and identical to the coating found on the predicate Citation TMZF HA Hip Stems.

  • 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 all of the following screw hole configurations:
    • Solid Back: No Screw Holes.
    • 3-Hole: Three screw holes clustered on the dome of the shell. -
    • ﺴﺖ 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

2

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 three fourths of the way up the face of the shells, decreasing gradually until the step profile is negated by the PS-HA coating.

Intended Use:

The Trident Acetabular Shells described in this 510(k) submission are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Osteonics Generation II 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 (Ti6Al4V ELI alloy). The subject Trident Acetabular Shells feature the same PS-HA coating featured on the predicate Citation TMZF Hip Stems (K993768).

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 PS-HA 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. (This test data was incorporated by reference to a previous 510(k)).

4

Image /page/4/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the top half of the circle.

Public Health Service

4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terry Sheridan Powell Regulatory Affairs Team Member Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K001448

AUG

Trade Name: Trident Àcetabular Shells: PS-HA Regulatory Class: II Product Code: MEH 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) 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 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,

Dana 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): KOO |448

Device Name: Trident Acetabular Shells: PS-HA

Indications For Use:

The subject Trident Acetabular Shells are single-use devices intended for 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)


Prescription Use/

OR

Over-The-Counter Use

510(k) Number_KOO1448

(Division of General Restorative Devices

Dulary (Division Sign-Off)

(Optional Format 1-2-96)

(Per 21 CFR 801.109)