(28 days)
The TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.
The TriFlange Hip Prosthesis is indicated in the following conditions:
- Where bones loss is present in the acetabular region
- Pelvic discontinuities
Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.
The system is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Porous-coated TriFlange Hip Prostheses are indicated for cement-less applications.
The 3D Additive TriFlange Acetabular Cup and TriFlange II Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup (Pinnacle cup) with three patients specific illial, ischial and pubic flanges added to reinforce weak acetabula. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges. The 3D Additive TriFlange Acetabular Cup is manufactured via additive manufacturing technology using Ti6Al4V ELI powder, followed by traditional finishing operations. TriFlange II Acetabular Cup System is following traditional CNC machining manufacturing process. The cups are intended for cementless use only. The proposed changes apply to product codes with hydroxyapatite (HA) coating.
The provided FDA 510(k) summary (K232556) does not contain information about an AI/ML-driven medical device and therefore does not include acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance.
The submission is for a hip joint prosthesis (DePuy 3D Additive TriFlange Acetabular Cup and TriFlange II Acetabular Cup System), and the only change for this submission is that the Hydroxyapatite (HA) coating process will be conducted at an alternate facility. The substantial equivalence is based on non-clinical tests demonstrating that the material and coating properties remain consistent with the predicate devices, despite the change in manufacturing location for the HA coating.
Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this specific 510(k) submission.
The document mentions "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE" and lists several engineering/material tests (e.g., HA Powder characterization, HA Coating thickness, Tensile Adhesion testing, Shear Adhesion testing, Rotating Beam Fatigue, Solubility, Dissolution, FTIR analysis). It explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence."
In summary, this document does not describe the kind of device or study you are asking about.
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September 20, 2023
DePuy Ireland UC Susan Mullane Associate Director Regulatory Affairs Loughbeg, Ringaskiddy Cork, Ireland
Re: K232556
Trade/Device Name: DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup 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, MEH Dated: August 23, 2023 Received: August 23, 2023
Dear Susan Mullane:
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 aware 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.
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Limin Sun
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K232556
Device Name
DePuy 3D Additive TriFlange Acetabular Cup
Indications for Use (Describe)
The TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.
The TriFlange Hip Prosthesis is indicated in the following conditions:
-
Where bones loss is present in the acetabular region
-
Pelvic discontinuities
Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.
|X 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."
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Indications for Use
510(k) Number (if known) K232556
Device Name
DePuy TriFlange II Acetabular Cup System
Indications for Use (Describe)
The system is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty.
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Total hip replacement is indicated in the following conditions:
-
A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia.
-
Avascular necrosis of the femoral head.
-
Acute traumatic fracture of the femoral head or neck.
-
Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
-
Certain cases of ankylosis.
Porous-coated TriFlange Hip Prostheses are indicated for cement-less applications.
| 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."
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510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, RingaskiddyCork, IRELAND |
| Phone number | 35 (32) 149-14000 |
| Fax number | 574- 371-4987 |
| Establishment RegistrationNumber | 3015516266 |
| Name of contact person | Susan Mullane |
| Date prepared | 19th September 2023 |
| Name of device | |
| Trade or proprietaryname | DePuy 3D Additive TriFlange Acetabular CupDePuy TriFlange II Acetabular Cup System |
| Common or usual name | Acetabular cup |
| Classification name | Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesisHip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3358, 888.3353 |
| Product Code(s) | LPH, MEH |
| Legally marketed device(s)to which equivalence isclaimed | DePuy 3D Additive TriFlange Acetabular Cup (K201348)DePuy TriFlange II Acetabular Cup System (K040383) (Primary Predicate) |
| Reason for 510(k) submission | The only change for this submission is that the HA coating process will be conducted at an alternate facility. All other process remain the same and within the same approved facility. |
| Device description | The 3D Additive TriFlange Acetabular Cup and TriFlange II Acetabular Cup System is an acetabular cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup (Pinnacle cup) with three patients specific illial, ischial and pubic flanges added to reinforce weak acetabula. The device may be fixed in place with titanium bone screws of various lengths through a variety of screw holes in the flanges. The 3D Additive TriFlange Acetabular Cup is manufactured via additive manufacturing technology using Ti6Al4V ELI powder, followed by traditional finishing operations. TriFlange II Acetabular Cup System is following traditional CNC machining manufacturing process. The cups are intended for cementless use only. The proposed changes apply to product codes with hydroxyapatite (HA) coating. |
| Intended use of the device | Total hip arthroplasty |
| Indications for use | DePuy 3D Additive TriFlange Acetabular Cup (K201348): The TriFlange Hip Prosthesis is intended to be used with modular liners to resurface the acetabular socket in cementless application during total hip arthroplasty. The TriFlange Hip Prosthesis is indicated in the following conditions: 1. Where bones loss is present in the acetabular region 2. Pelvic discontinuities Porous-coated TriFlange Hip Prostheses are indicated for cementless applications. |
| DePuy TriFlange II Acetabular Cup System (K040383): | |
| The system is intended to be used with modular liners to resurface theacetabular socket in cementless application during total hip arthroplasty. | |
| Total hip arthroplasty is intended to provide increased patient mobility andreduce pain by replacing the damaged hip joint articulation in patients wherethere is evidence of sufficient sound bone to seat and support thecomponents. | |
| Total hip replacement is indicated in the following conditions: | |
| 1. A severely painful and/or disabled joint from osteoarthritis, traumaticarthritis, rheumatoid arthritis, or congenitalhip dysplasia. | |
| 2. Avascular necrosis of the femoral head. | |
| 3. Acute traumatic fracture of the femoral head or neck. | |
| 4. Failed previous hip surgery including joint reconstruction, internalfixation, arthrodesis, hemi-arthroplasty, surfacereplacement arthroplasty, or total hip replacement. | |
| 5. Certain cases of ankylosis. | |
| Porous-coated TriFlange Hip Prostheses are indicated for cement-lessapplications. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | ||||
|---|---|---|---|---|
| Characteristics | Subject Device:Triflange | Predicate Device:DePuy 3D Additive TriFlangeAcetabular Cup (K201348) | Predicate Device:DePuy TriFlange II Acetabular CupSystem (K040383) | |
| Intended Use | Total Hip Arthroplasty | Same | Same | |
| Material | The Triflange acetabular shells, subjectof this submission, are manufacturedfrom titanium alloy (Ti6Al4V) forsurgical implant applications and arecoated with beaded porous coating andplasma sprayed with hydroxyapatite(HA), which are identical materials tothe predicate devices.The HA Coating process will becompleted in an alternate site. | Ti6Al4V with Porocoat, with and withoutplasma sprayed HA coating | Same | |
| Fixation | Uncemented | Same | Same | |
| Cup Sizes | 48mm OD to 66mm OD | Same | Same | |
| Flange Sizes | Patient specific | Same | Same | |
| Sterile Method | Gamma | Same | Same |
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| Packaging | Double PETG blister with Tyvek peel lid | Same | Same |
|---|---|---|---|
| Shelf Life | 5 years | Same | Same |
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
□ HA Powder characterization to ISO 13779-6, ISO 13779-2 ISO 13779-3 and ASTM F1185.
□ HA Coating thickness per ASTM F1854.
□ HA Coating characterization to ISO 13779-6, ISO 13779-2 ISO 13779-3 and ASTM F1185.
□Tensile Adhesion testing per ASTM F1147-05.
□Shear Adhesion testing per ASTM F1044-05.
□Rotating Beam Fatigue per ASTM F1160.
□ Solubility of HA particles before and after HA coating
□ Dissolution of HA particles before and after HA coating per ASTM F1926-10
□ FTIR analysis of HA powder before and after HA coating.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF
CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject devices are substantially equivalent to the predicate DePuy 3D Additive TriFlange Acetabular Cup (K201348) and DePuy TriFlange II
Acetabular Cup System (K040383).
§ 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.