(110 days)
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 for Use:
• 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.
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.
This document describes a 510(k) premarket notification for the "Trident® II Acetabular System," a medical device for total hip arthroplasty. The submission asserts substantial equivalence to previously marketed predicate devices, and therefore, clinical testing was not required. The information provided focuses on non-clinical testing.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported performance for each criterion. Instead, it lists a series of non-clinical tests performed, implying that the device "meets the requirements" or was "characterized according to methods" outlined in various ASTM standards and FDA guidance documents.
Here's a partial reconstruction of what could be inferred as acceptance criteria and "device performance" based on the text:
| Acceptance Criteria (Inferred from Test Objective/Guidance) | Reported Device Performance (Implied) |
|---|---|
| Mechanical Stability (Cementless Fixation): | |
| Resist push-out forces (ASTM F1820) | Testing performed. Implied to meet requirements. |
| Resist lever-out forces (ASTM F1820) | Testing performed. Implied to meet requirements. |
| Resist torque-out forces (ASTM F1820) | Testing performed. Implied to meet requirements. |
| Durability/Fatigue: | |
| Withstand acetabular shell fatigue (Acetabular Shell Fatigue Testing) | Testing performed. Implied to meet requirements. |
| Wear/Interface Performance: | |
| Minimal fretting at MDM liner interface (Fretting Evaluation of the MDM liner) | Testing performed. Implied to meet requirements. |
| Material Properties: | |
| Resistance to plastic deformation (Plastic Deformation) | Testing performed. Implied to meet requirements. |
| Material chemistry meets specifications (Material Chemistry) | Testing performed. Implied to meet requirements. |
| Porous surface meets FDA guidance for orthopedic implants with modified metallic surfaces (Characterization of Chemistry, Physical & Mechanical Properties of porous surface) | Established that porous surface meets requirements. |
| Titanium plasma spray characterized per guidance (Characterization of Chemistry, Physical & Mechanical Properties of porous surface) | Characterized according to methods. |
| Biocompatibility/Pyrogenicity: | |
| Endotoxin limit < 20EU/Device (Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011) | Achieved an Endotoxin limit of < 20EU/Device. |
| MR Compatibility: | |
| Magnetically Induced Displacement Force (ASTM F2052-06, F2052-14) | Compatibility characterized; parameters for safe scanning provided. |
| Magnetically Induced Torque (ASTM F2213-06) | Compatibility characterized; parameters for safe scanning provided. |
| Image Artifact (ASTM F2119-07) | Compatibility characterized; parameters for safe scanning provided. |
| Heating by RF Fields (ASTM F2182-11a) | Compatibility characterized; parameters for safe scanning provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample sizes used for each non-clinical test (e.g., how many shells were tested for fatigue, how many samples for material chemistry, etc.). It only mentions that "testing was performed."
Since these are non-clinical (laboratory/bench) tests, the concept of "country of origin of data" or "retrospective/prospective" does not directly apply in the way it would for human study data. These tests would typically be conducted in a laboratory environment associated with the manufacturer or a contract testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as no clinical studies were performed. The "ground truth" for non-clinical tests is established by adhering to widely accepted engineering standards (e.g., ASTM standards) and FDA guidance documents. The "experts" would be the engineers and technicians performing the tests and
interpreting the results according to these predefined standards. Their qualifications are not specified but are implied to be sufficient for compliance with these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as no clinical studies were performed requiring human adjudication on a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is an orthopedic implant, not an AI/imaging device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is an orthopedic implant, not an algorithm. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that the testing was non-clinical:
- Mechanical Tests (e.g., push-out, fatigue): The ground truth is defined by the objective performance criteria set forth in relevant ASTM standards (e.g., minimum force required to cause failure, number of cycles to failure). The device either meets these engineering specifications or it does not.
- Material Characterization: The ground truth is defined by material specifications (e.g., chemical composition per ASTM F136, F1580, F1472; hydroxylapatite per ASTM F1185) and the requirements outlined in FDA guidance documents for porous surfaces.
- Biocompatibility/Pyrogenicity: The ground truth is defined by the ANSI/AAMI ST72:2011 standard, specifically the endotoxin limit of < 20EU/Device.
- MRI Compatibility: The ground truth is defined by the requirements of the listed ASTM standards (F2052, F2213, F2119, F2182) and FDA guidance documents, which determine the conditions under which the device is safe within an MR environment.
8. The sample size for the training set
This is not applicable as there is no mention of any machine learning or AI component requiring a training set. The device is a physical orthopedic implant.
9. How the ground truth for the training set was established
This is not applicable as there is no machine learning or AI component requiring a training set and its associated ground truth.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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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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510(k) Summary
| Sponsor | Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430 |
|---|---|
| Contact Person | Valerie GiambancoStaff Regulatory Affairs SpecialistStryker OrthopaedicsValerie.giambanco@stryker.comPh: 201-831-6275Fax: 201-831-3275 |
| Date Prepared: | Sept 27, 2017 |
| Proprietary Name:Common Name: | Trident® II Acetabular SystemTotal Hip Joint Replacement |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis. (888.3358) |
| Hip joint metal/polymer constrained cementedor uncemented prosthesis. (888.3310) | |
| Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous 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:
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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 F1580Hydroxylapatite 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:
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• 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
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- 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 < 20EU/Device.
- . MRI Analysis: Non-clinical testing as outlined in the FDA guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment – Guidance for Industry and FDA Staff", dated December 11, 2014 was conducted to characterize the compatibility of Trident II Acetabular System and compatible total hip passive implants in the MR environment. FDA draft guidance "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Draft Guidance for Industry and FDA Staff", dated June 29, 2015 was also consulted for the heating evaluations performed. Testing was performed according to the standards listed below:
- o Magnetically Induced Displacement Force performed per ASTM F2052-06 and ASTM F2052-14, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment
- o Magnetically Induced Torque performed per ASTM F2213-06 (Reapproved 2011), Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment
- o Image Artifact performed per ASTM F2119-07 (Reapproved 2013), Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
- o Heating by RF Fields per ASTM F2182-11a, Standard Test Method for Measurement of Radio Frequency Induced Heating near Passive Implants during MR Imaging
The labeling of the Trident II Acetabular System and compatible total hip implants has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Conclusion: Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the Trident® II Acetabular System is substantially equivalent to the predicate devices identified in this premarket notification.
§ 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.