(129 days)
No
The device description and performance studies focus on the material properties, manufacturing process, and mechanical testing of the acetabular shell and screws, with no mention of AI or ML.
Yes
The device, an acetabular shell system for total hip arthroplasty, is intended to treat painful and disabling joint diseases, revision of previous unsuccessful procedures, and other clinical management problems associated with the hip, which aligns with the definition of a therapeutic device.
No
Explanation: The device described is an acetabular shell system intended for use in total hip arthroplasty, which is a treatment for painful joint disease. It is an implant used for reconstruction, not for diagnosing conditions.
No
The device description clearly states it is a physical implant (Acetabular Shell and screws) made of Ti-6Al-4V ELI alloy, intended for surgical implantation. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating painful and disabling joint disease of the hip. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an acetabular shell and screws, which are physical implants used in surgery. IVD devices are typically reagents, instruments, or systems used to examine specimens like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing information for diagnosis based on in vitro testing.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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 Tritanium Acetabular Shells are indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH, KWZ, LZO, JDI, MEH
Device Description
The Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screws 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 Tritanium® Acetabular Shell is an extension of the Trident System product line and features the same locking mechanism as the current Trident® Tritanium® product line. The Trident® II Tritanium® Acetabular Shell is intended to be used with existing Trident® polyethylene inserts, MDM® liners and existing surgical instruments.
The subject device is manufactured from Ti-6Al-4V ELI alloy. The implant consists of a unique configuration of both solid and porous structures that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology.
There are three designs of Trident® II Tritanium® Acetabular Shells:
- Solidback (sizes 42A-66H)
- Clusterhole (sizes 42A-66H)
- Multihole (sizes 42A-72J) ●
The new compatible 6.5mm Low Profile Hex Screws feature a hex geometry and are manufactured from wrought Ti-6Al-4V ELI. The new screws range in lengths from 15-80mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, acetabulum, proximal femur
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 to determine substantial equivalence:
- . Push out (ASTM F1820)
- Lever out (ASTM F1820)
- Torque out (ASTM F1820)
- Range of Motion Analysis
- Fatigue
- Fretting Evaluation of the MDM liner
- Bone Screw Testing (ASTM F543)
- Plastic Deformation
- Material Chemistry
- . Characterization of the 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
- Bacterial endotoxin testing (BET) was used for pyrogenicity testing to achieve an . acceptable endotoxin limit as specified in ANSI/AAMI ST72:2011.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
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.
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.
K152304, K142606, K944213, K903362, K983382, K151264
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
§ 888.3358 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 & 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 an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
Stryker Orthopaedics Valerie Giambanco Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K161569 Trade/Device Name: Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws 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, KWZ, LZO, JDI, MEH Dated: August 31, 2016 Received: September 1, 2016
Dear 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 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
1
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/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 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,
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): K161569
Device Name: Trident® II Tritanium® Acetabular Shells and 6.5mm Low Profile Hex Screws Indications for Use:
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 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 Tritanium Acetabular Shells are indicated for cementless use only.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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: | October 14, 2016 |
| Proprietary Name: | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex
Screws |
| Common Name: | 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:
- Tritanium® Acetabular Shell System (K081171) [Shell] ●
- Restoration Acetabular Cup (K943549) [Screw] .
Legally Marketed Reference Devices Used to Support Substantial Equivalence:
- Tritanium® PL Cage (K152304) ●
- . Trident® Tritanium® PST® Acetabular Shells (K142606)
- Vitallium Cancellous Bone Screw (K944213) .
4
- Osteolock Acetabular Cup & Bone Screw (K903362)
- . Osteonics® HA Generation II Acetabular Component System (K983382)
- Restoration Anatomic Shell (K151264)
Device Description:
The Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screws 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 Tritanium® Acetabular Shell is an extension of the Trident System product line and features the same locking mechanism as the current Trident® Tritanium® product line. The Trident® II Tritanium® Acetabular Shell is intended to be used with existing Trident® polyethylene inserts, MDM® liners and existing surgical instruments.
The subject device is manufactured from Ti-6Al-4V ELI alloy. The implant consists of a unique configuration of both solid and porous structures that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology.
There are three designs of Trident® II Tritanium® Acetabular Shells:
- Solidback (sizes 42A-66H)
- Clusterhole (sizes 42A-66H)
- Multihole (sizes 42A-72J) ●
The new compatible 6.5mm Low Profile Hex Screws feature a hex geometry and are manufactured from wrought Ti-6Al-4V ELI. The new screws range in lengths from 15-80mm.
Intended Use:
The Trident® II Tritanium® Acetabular Shell is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.
Indications:
The Trident® II Tritanium® Acetabular Shells have the same Indications for Use as the Tritanium® Acetabular Shells – with the additional specific indications noted for MDM® and Constrained Insert compatibility, as identical to the recently cleared Restoration® Anatomic Shell (K151264). The optional compatible bone screws share indications as the mating acetabular shell.
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.
5
• 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 Tritanium Acetabular Shells are indicated for cementless use only.
Summary of Technological Characteristics: Device comparisons and performance testing show that the Trident® II Tritanium® Acetabular Shell and 6.5mm Low Profile Hex Screw are 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 to determine substantial equivalence:
- . Push out (ASTM F1820)
- Lever out (ASTM F1820)
- Torque out (ASTM F1820)
- Range of Motion Analysis
- Fatigue
- Fretting Evaluation of the MDM liner
- Bone Screw Testing (ASTM F543)
- Plastic Deformation
- Material Chemistry
- . Characterization of the 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
6
- Bacterial endotoxin testing (BET) was used for pyrogenicity testing to achieve an . acceptable endotoxin limit as specified in ANSI/AAMI ST72:2011.
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 Tritanium® Acetabular Shell and the 6.5mm Low Profile Hex Screw are substantially equivalent to the predicate devices identified in this premarket notification.