(190 days)
No
The document describes modifications to existing hip replacement components (acetabular inserts and femoral stems) related to material, sterilization, and instrumentation compatibility. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies are focused on material properties, biocompatibility, sterilization, and mechanical testing, not algorithmic performance.
Yes
The devices are hip replacement components (total hip arthroplasty systems) used to treat painful and disabling joint diseases. Their intended use is to alleviate and correct medical conditions, functioning as a therapeutic intervention.
No
The device description and intended use focus on components for hip replacement surgery (e.g., acetabular inserts, hip systems), which are implantable medical devices used to treat joint disease, not to diagnose it.
No
The device description and performance studies clearly indicate that the device is a physical implant (acetabular inserts and hip system components) made of UHMWPE, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the surgical treatment of painful and disabling hip joint diseases, revision procedures, and situations with poor bone stock. These are all clinical applications involving direct surgical intervention on the patient's body.
- Device Description: The device is described as acetabular components (inserts, cups, liners) and femoral stems, which are implants used in hip replacement surgery.
- No mention of in vitro testing: There is no indication that this device is intended to be used for testing samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Anatomical Site: The anatomical site is the hip, which is a part of the human body where surgical procedures are performed.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is an implantable medical device used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
Trident Acetabular Component System
Indications for Use:
- Painful, disabling joint disease of the hip 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 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.
Restoration ADM Acetabular Cup and MDM Liner Systems
The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis:
- Correction of functional deformity:
- Revision procedures where other treatments or devices have failed; and,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks
RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only.
Accolade II Hip System
The indications for use of the total hip replacement prostheses include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- rheumatoid arthritis:
- correction of functional deformity:
- revision procedures where other treatments or devices have failed; and,
- nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
Product codes
LPH, JDI, MEH, LZO, KWL, KWY, KWZ, LWJ
Device Description
The subject X3 UHMWPE Acetabular Inserts for the Trident, Restoration ADM and MDM Liner systems are a modified version of their respective predicate devices. The subject device designs are identical to their respective predicates, but the subject devices will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648.
The subject Accolade II Hip System is identical to the predicate Accolade II Hip System, with the exception that it has additional compatibility with new instrumentation which utilizes an addendum to the current surgical protocol.
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:
-
- Material testing per ASTM F648, ASTM F2565, and Draft FDA Guidance, "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" (February 12, 2016).
-
- Biocompatibility Evaluation per ISO 10993-1:2009. ISO 10993-7:2008. and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16. 2016)
-
- Ethylene oxide sterilization validation per ISO 11135:2014
-
- Bacterial endotoxin testing (BET)
-
- Trident axial push out testing
-
- Trident rim loading fatigue testing
-
- Trident wear testing based on ISO/DIS 14242-1
-
- MDM Liner cam-out testing
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)
K033716, K061434, K062419, K153345, K093644, K103233, K112556, K153345, K103479, K120578, K153345
Reference Device(s)
K172634, K983502, K983382, K072020
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/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Howmedica Osteonics Corp aka Stryker Orthopaedics Krutanjali Shah Manager, Regulatory Affairs 325 Corporate Dr. Mahwah, New Jersey 07430
May 13, 2019
Re: K182468
Trade/Device Name: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip 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, MEH, LZO, KWL, KWZ, LWJ, KWY Dated: September 5, 2018 Received: September 10, 2018
Dear Krutanjali Shah:
This letter corrects our substantially equivalent letter of March 19, 2019.
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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Vesa Vesa Vuniqi -Vuniai -S ഗ Date: 2019.05.13 22:59:04 -04'00' For: CAPT Raquel Peat, PhD, MPH, USPHS Director
Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K 182468
Device Name
Trident® X3@ UHMWPE Acetabular Inserts, Restoration ADM® and MDM® X3® UHMWPE Acetabular Inserts
Indications for Use (Describe) Trident Acetabular Component System
Indications for Use: · Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid 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 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.
Restoration ADM Acetabular Cup and MDM Liner Systems
The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
- Rheumatoid arthritis:
-
- Correction of functional deformity:
-
Revision procedures where other treatments or devices have failed; and,
-
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
-
Dislocation risks
RESTORATION ADM HA Cups and MDM Liners are intended 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K182468
Device Name Accolade II Hip System
Indications for Use (Describe) Accolade II Hip System
The indications for use of the total hip replacement prostheses include:
-
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
-
- rheumatoid arthritis:
-
- correction of functional deformity:
-
- revision procedures where other treatments or devices have failed; and,
-
- nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head
involvement that are unmanageable using other techniques.
Additional indication specific to use of ACCOLADE II Femoral Stens with compatible Howmedica Osteonics
Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the
device is intended for use in primary or revision patients at high risk of hip dislocation due to a
history of prior dislocation, bone loss, soft tissue laxity, neuronuscular disease, or intra-operative instability.
ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED
SEPARAIL
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Section 5: 510(k) Summary
5
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Krutanjali Shah
Manager, Regulatory Affairs
Howmedica Osteonics Corp
325 Corporate Drive, Mahwah, NJ 07430
Phone: (201) 831-5665 |
| Date Prepared: | March 15, 2019 |
| Proprietary Name: | Trident® X3® UHMWPE Acetabular Inserts,
Restoration ADM® and MDM® X3® UHMWPE Acetabular Inserts,
Accolade® II Hip System |
| Common Name: | Total Hip Joint Replacement |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis (21 CFR 888.3358) |
| | Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350) |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (21 CFR 888.3353) |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis (21 CFR 888.3360) |
| | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented
prosthesis (21 CFR 888.3390) |
| | Hip joint metal/polymer constrained cemented or uncemented
prosthesis (21 CFR 888.3310) |
| Product Codes: | LPH, JDI, MEH, LZO, KWL, KWY, KWZ, LWJ |
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
- Trident® X3® Acetabular Inserts (K033716, K061434, K062419, K153345) .
- Restoration ADM® and MDM® X3® Acetabular Inserts (K093644, K103233, K112556, . K153345)
- . Accolade® II Hip System (K103479, K120578, K153345)
Legally Marketed Reference Devices Used to Support Substantial Equivalence:
- Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components (K172634) ●
- Trident® N2Vac UHMWPE Acetabular Inserts (K983502, K983382) ●
- . Restoration ADM® Duration® UHMWPE Acetabular Inserts (K072020)
6
Device Description: The subject X3 UHMWPE Acetabular Inserts for the Trident, Restoration ADM and MDM Liner systems are a modified version of their respective predicate devices. The subject device designs are identical to their respective predicates, but the subject devices will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648.
The subject Accolade II Hip System is identical to the predicate Accolade II Hip System, with the exception that it has additional compatibility with new instrumentation which utilizes an addendum to the current surgical protocol.
Intended Use:
The subject devices have the same intended use as those specified in the 510(k) clearances for the predicate devices listed.
Indications:
Trident Acetabular Component System
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.
Restoration ADM Acetabular Cup and MDM Liner Systems
The indications for use for total hip arthroplasty include:
- . Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- Rheumatoid arthritis; ●
- Correction of functional deformity; ●
- Revision procedures where other treatments or devices have failed; and, ●
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.
- Dislocation risks ●
RESTORATION ADM HA Cups and MDM Liners are intended for cementless use only.
Accolade II Hip System
The indications for use of the total hip replacement prostheses include:
- noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
-
- rheumatoid arthritis:
-
- correction of functional deformity:
-
- revision procedures where other treatments or devices have failed: and.
-
- nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head
7
involvement that are unmanageable using other techniques.
Additional indication specific to use of ACCOLADE II Femoral Stems with compatible Howmedica Osteonics Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability.
ACCOLADE II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
Summary of Technological Characteristics: The subject X3 UHMWPE Acetabular Inserts are identical in intended use, indications, design, and operational principles to the predicate devices. The subject devices differ from the predicate devices with regard to their terminal sterilization method: The subject devices are terminally sterilized by Ethylene Oxide, whereas the predicate devices are sterilized using Gas Plasma. Consolidation of X3 polyethylene is performed using conventional methods. The X3 UHMWPE material continues to meet the same ASTM F648 specification.
The subject Accolade II Hip System is identical in intended use, indications, design, and operational principles to the predicate Accolade II Hip System. The subject device differs from the predicate device with regard to additional compatibility with new instruments which utilizes an updated surgical technique.
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence:
-
- Material testing per ASTM F648, ASTM F2565, and Draft FDA Guidance, "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" (February 12, 2016).
-
- Biocompatibility Evaluation per ISO 10993-1:2009. ISO 10993-7:2008. and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16. 2016)
-
- Ethylene oxide sterilization validation per ISO 11135:2014
-
- Bacterial endotoxin testing (BET)
-
- Trident axial push out testing
-
- Trident rim loading fatigue testing
-
- Trident wear testing based on ISO/DIS 14242-1
-
- MDM Liner cam-out testing
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Conclusion: The subject X3 UHMWPE Acetabular Inserts and Accolade II Hip System are substantially equivalent to their respective predicate devices identified in this premarket notification.
8
Device comparison showed that the proposed devices are substantially equivalent in intended use, technological characteristics and principles of operation as compared to the predicate devices. The proposed modifications do not affect safety or effectiveness.