(133 days)
No
The summary describes a mechanical implant (acetabular shell) and its compatibility with existing components. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies focus on mechanical testing and material comparisons.
Yes
The device is an acetabular shell system for total hip replacement, which is a surgical procedure to alleviate severe pain and disability, thus fulfilling a therapeutic purpose by improving the patient's condition.
No
This device is an acetabular shell system intended for surgical implantation in total hip replacement, which is a therapeutic intervention, not a diagnostic one. It treats conditions rather than identifying or assessing them.
No
The device description clearly states the device is an acetabular shell system made from titanium alloy, which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Trident® Tritanium® PST® Acetabular Shell System is an implantable device used in surgery for total hip replacement. It is a physical component intended to replace a damaged hip joint.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, the Trident® Tritanium® PST® Acetabular Shell System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Trident® Tritanium® PST® Acetabular Shell System is in skeletally mature individuals undergoing surgery for total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
· Acute traumatic fracture of the femoral head or neck;
· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
Product codes
LPH, JDI
Device Description
The subject Trident® Tritanium® PST® Acetabular Shell is the predicate PST® Acetabular Shell, which has been modified to incorporate the acetabular bearing mating features of the predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells, to allow compatibility with existing Stryker Orthopaedics acetabular bearings including the Trident polyethylene and Modular Dual Mobility (MDM) bearing families.
The subject Trident® Tritanium® PST® Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface. The subject shells feature a dome hole, and are available either in a solid shell (no screw holes) configuration, or in a cluster screw hole configuration for optional supplemental bone screw fixation. The subject Tritanium® PST® Acetabular Shells are compatible with the optional predicate PST Acetabular Shell system bone screws (titanium alloy), with the optional predicate Stryker Orthopaedics Torx head acetabular dome hole occluder (CP titanium), and with an optional new hex head acetabular dome hole occluder (titanium alloy).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
skeletally mature individuals
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
Comparisons of materials, manufacturing methods, and design features, as well as disassembly testing per ASTM F1820 (including push-out, and torsional testing) for the subject shells with the worst case style and size of compatible Stryker Orthopaedics acetabular bearings, were relied upon to demonstrate the substantial equivalence of the modified subject device to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K112802, K081171, K983382, K013676
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
MAKO Surgical Corporation % Terry Sheridan Powell M Squad Associates, Incorporated 575 Eighth, Avenue, Suite 1212 New York City, New York 10018
Re: K142606 Trade/Device Name: Trident® Tritanium® PST® Acetabular Shells 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, JDI Dated: December 22, 2014 Received: December 29, 2014
Dear Terry Sheridan Powell:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Terry Sheridan Powell
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142606
Device Name
Trident® Tritanium® PST® Acetabular Shells
Indications for Use (Describe)
The Trident® Tritanium® PST® Acetabular Shell System is in skeletally mature individuals undergoing surgery for total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
· Acute traumatic fracture of the femoral head or neck;
· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.
1.1. Device Name and Classification
| Device Trade Name: | Trident® Tritanium® PST® Acetabular Shells |
|---|---|
| Device Common Name: | Artificial Total Hip Replacement |
| Regulation Number and Description: | 888.3358 - Hip joint metal/polymer/metal semi- |
| constrained porous-coated uncemented | |
| prosthesis; and 888.3350 - Hip joint | |
| metal/polymer semi-constrained cemented | |
| prosthesis | |
| Device Class: | II |
| Product Codes: | LPH - prosthesis, hip, semi-constrained, |
| metal/polymer, porous uncemented | |
| JDI - prosthesis, hip, semi-constrained, | |
| metal/polymer, cemented | |
| Advisory Panel: | Orthopedic |
1.2. Address and Registration
| Submitter's Name: | MAKO Surgical Corp. |
|---|---|
| Address: | 3 Wing Drive Suite 102 Cedar Knolls, NJ 07927 |
| Establishment Registration Number: | 3009701876 |
| Contact Person: | Jonathan Reeves |
| Telephone Number: | 954-628-0665 |
| Fax Number: | 954-927-0446 |
| Date Summary Prepared: | January 8, 2015 |
1.3. Purpose of Submission
The Trident® Tritanium® PST® Acetabular Shell is a new device.
1.4. Identification of Legally Marketed Device to which Submitter Claims Equivalence
The subject device is substantially equivalent to the following predicate devices:
| Device Description | 510(k) Numbers |
|---|---|
| PST® Acetabular Shells (and dome hole plug) | K112802 |
| Trident® Tritanium®, Trident® PSL® and Trident® | |
| Hemispherical Shells | K081171, K983382, K013676 |
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1.5. Device Description
The subject Trident® Tritanium® PST® Acetabular Shell is the predicate PST® Acetabular Shell, which has been modified to incorporate the acetabular bearing mating features of the predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells, to allow compatibility with existing Stryker Orthopaedics acetabular bearings including the Trident polyethylene and Modular Dual Mobility (MDM) bearing families.
The subject Trident® Tritanium® PST® Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface. The subject shells feature a dome hole, and are available either in a solid shell (no screw holes) configuration, or in a cluster screw hole configuration for optional supplemental bone screw fixation. The subject Tritanium® PST® Acetabular Shells are compatible with the optional predicate PST Acetabular Shell system bone screws (titanium alloy), with the optional predicate Stryker Orthopaedics Torx head acetabular dome hole occluder (CP titanium), and with an optional new hex head acetabular dome hole occluder (titanium alloy).
1.6. Intended Use
The Trident® Tritanium® PST® Acetabular Shell System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
- . A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
- . Acute traumatic fracture of the femoral head or neck;
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
1.7. Comparison of Technological Characteristics
The subject Trident® Tritanium® PST® Acetabular Shells have the same indications for use, same outer profile, same porous structured surface, and are made from the same materials using the same manufacturing, similar packaging, and same sterilization methods as the predicate PST® Acetabular Shells. The subject Trident® PST® Acetabular Shells incorporate the acetabular bearing mating features of the predicate Trident® Trident® PSL® and Trident® Hemispherical Shells, and are therefore compatible with existing Stryker acetabular bearings, including the Trident polyethylene and Modular Dual Mobility (MDM) bearing families.
1.8. Performance Testing
Comparisons of materials, manufacturing methods, and design features, as well as disassembly testing per ASTM F1820 (including push-out, and torsional testing) for the subject shells with the worst case style and size of compatible Stryker Orthopaedics acetabular bearings, were relied upon to demonstrate the substantial equivalence of the modified subject device to the predicate devices.
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1.9. Clinical Testing
Clinical testing was not required to demonstrate substantial equivalence to the predicates.
1.10.Conclusions
The subject Trident® Tritanium® PST® Acetabular Shells share indications for use, same outer profile, same porous structured surface, and are made from the same materials using the same manufacturing, similar packaging, and same sterilization methods as the predicate PST® Acetabular Shells. The subject Trident® Tritanium® PST® Acetabular Shells share the acetabular bearing mating features of the predicate Trident® Trident® PSL® and Trident® Hemispherical Shells, for compatibility with the same predicate Trident polyethylene and Modular Dual Mobility (MDM) bearing families. Therefore, the subject Trident® Tritanium® PST® Acetabular Shells are substantially equivalent to the identified predicate acetabular shells.