(110 days)
No
The document describes a mechanical implant for hip replacement and does not mention any AI or ML components in its intended use, device description, or performance studies.
Yes
The device is described as an "Acetabular System" intended for use in total hip arthroplasty, addressing painful and disabling joint diseases. It is a physical implant designed to replace a damaged joint, which is a therapeutic function.
No
Explanation: This device is an acetabular system intended for use in total hip arthroplasty, which is a surgical procedure to replace a damaged hip joint. Its purpose is to treat painful and disabling joint diseases or revise previous unsuccessful procedures. It is an implant used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a physical implant (Acetabular Shells, screws, and plugs) made of titanium and intended for surgical implantation in total hip arthroplasty. While it mentions MRI analysis for compatibility, this is testing of the physical device, not the device itself being software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip arthroplasty, a surgical procedure to replace the hip joint. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is an acetabular system, which are implants used in hip replacement surgery. These are physical devices implanted into the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition.
- Performance Studies: The performance studies focus on the mechanical properties, compatibility with the MR environment, and other aspects relevant to an implantable device, not the analytical performance of a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
Indications for Use
• Painful, disabling joint disease of the hip resulting from: degenerative 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 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.
When used with MDM Liners
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks
When used with Constrained Liner
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Acetabular Shells are indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI, KWZ, LZO, MEH
Device Description
The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and Hex Dome Hole Plug are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular System is an extension of the Trident System product line and features the same locking mechanism as the current Trident® and Trident® II Tritanium® product lines. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments.
The Trident® II Tritanium® implant consists of a unique configuration of both solid and porous sections that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology. Tritanium® is a novel highly porous titanium material designed for biological fixation. The Trident® II PSL® Clusterhole HA and Trident® II Clusterhole HA Acetabular Shells feature hydroxylapatite coating over a Commercially Pure Titanium plasma sprayed surface for cementless fixation.
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)
Non-Clinical Testing: The following non-clinical laboratory testing was performed or engineering analysis was conducted to determine substantial equivalence:
- Push out (ASTM F1820)
- Lever out (ASTM F1820)
- Torque out (ASTM F1820)
- Range of Motion Analysis
- Acetabular Shell Fatigue Testing
- Fretting Evaluation of the MDM liner
- Bone Screw Testing (ASTM F543)
- Plastic Deformation
- Material Chemistry
- Characterization of the Chemistry, Physical and Mechanical Properties of the porous surface –this testing established that the porous surface meets the requirements outlined in the FDA guidance documents, "Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement", April 28, 1994. The titanium plasma spray surface was also characterized according to the methods described in this guidance document.
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. aka Stryker Orthopaedics Ms. Valerie Giambanco Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
October 2, 2017
Re: K171768 Trade/Device Name: Trident® II Acetabular System 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, KWZ, LZO, MEH Dated: August 31, 2017 Received: September 1, 2017
Dear Ms. Valerie Giambanco:
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 (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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 (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) 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.
Mark N. Melkerson -S
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) K171768
Device Name Trident II Acetabular System
Indications for Use (Describe)
Indications for Use
· Painful, disabling joint disease of the hip resulting from: degenerative 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 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.
When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks
When used with Constrained Liner
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident® II Acetabular Shells are indicated for cementless use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Valerie Giambanco
Staff Regulatory Affairs Specialist
Stryker Orthopaedics
Valerie.giambanco@stryker.com
Ph: 201-831-6275
Fax: 201-831-3275 |
| Date Prepared: | Sept 27, 2017 |
| Proprietary Name:
Common Name: | Trident® II Acetabular System
Total Hip Joint Replacement |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis. (888.3358) |
| | Hip joint metal/polymer constrained cemented
or uncemented prosthesis. (888.3310) |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (888.3353) |
| | Hip joint metal/polymer semi-constrained cemented prosthesis
(888.3350) |
| Product Codes: | LPH, KWZ, LZO, JDI, MEH |
Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed:
- Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws (K161569) o
- Osteonics Secur-Fit ™ HA Generation II [aka Trident PSL] Acetabular Shells (K983382, . K143085)
- Dome and Screw Hole Plugs (K920868)
Legally Marketed Reference Devices Used to Support Substantial Equivalence:
4
Device Description:
The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and Hex Dome Hole Plug are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular System is an extension of the Trident System product line and features the same locking mechanism as the current Trident® and Trident® II Tritanium® product lines. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments.
The Trident® II Tritanium® implant consists of a unique configuration of both solid and porous sections that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology. Tritanium® is a novel highly porous titanium material designed for biological fixation. The Trident® II PSL® Clusterhole HA and Trident® II Clusterhole HA Acetabular Shells feature hydroxylapatite coating over a Commercially Pure Titanium plasma sprayed surface for cementless fixation.
| Product | Material |
|---|---|
| Trident® II PSL® Clusterhole HA | Ti6Al4V ELI Alloy per ASTM F620, ASTM F136 |
| Trident® II Clusterhole HA | Commercially Pure (CP) Titanium per ASTM F1580 |
| Hydroxylapatite per ASTM F1185 | |
| Trident® II Tritanium® Solidback | Ti6Al4V Alloy per ASTM F1472 |
| Trident® II Tritanium® Clusterhole | Ti6Al4V Alloy per ASTM F1472 |
| Trident® II Tritanium® Multihole | Ti6Al4V Alloy per ASTM F1472 |
| Hex Dome Hole Plug | Ti6Al4V ELI Alloy per ASTM F136 |
| 6.5mm Low Profile Hex Screw | Ti6Al4V ELI Alloy per ASTM F136 |
The subject devices are manufactured from the following materials:
Intended Use:
The Trident® II Acetabular System is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.
Indications:
The Trident® II Acetabular System has the same Indications for Use as the Trident® II Tritanium® Acetabular Shells.
Indications for Use:
5
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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.
When used with MDM Liners:
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks
When used with Constrained Liners:
• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Trident II Acetabular Shells are indicated for cementless use only.
Summary of Technological Characteristics: Device comparisons and performance testing show that the Trident® II Acetabular System is substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.
Non-Clinical Testing: The following non-clinical laboratory testing was performed or engineering analysis was conducted to determine substantial equivalence:
- Push out (ASTM F1820)
- Lever out (ASTM F1820)
- Torque out (ASTM F1820)
- Range of Motion Analysis
- Acetabular Shell Fatigue Testing ●
- Fretting Evaluation of the MDM liner
- Bone Screw Testing (ASTM F543)
- Plastic Deformation
- Material Chemistry
6
- Characterization of the Chemistry, Physical and Mechanical Properties of the porous surface –this testing established that the porous surface meets the requirements outlined in the FDA guidance documents, "Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement", April 28, 1994. The titanium plasma spray surface was also characterized according to the methods described in this guidance document.
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of