(756 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 bone loss is present in the acetabular region
- Pelvic discontinuities
Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.
The 3D Additive TriFlange Acetabular Cup is a patient-specific cup system designed and manufactured to match the individual patient's anatomy. The system consists of a porous coated acetabular cup with three patient-specific ilial, ischial and pubic flanges. The cup is manufactured via additive manufacturing technology using Ti6Al4V ELI powder, followed by traditional finishing operations. The cups may have hydroxyapatite (HA) coating. The cups are intended for cementless use only.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "DePuy 3D Additive TriFlange Acetabular Cup." It details the device's characteristics, intended use, and substantial equivalence to a predicate device.
Key takeaway: This document does not pertain to an AI/ML powered medical device. It's about a physical implant (acetabular cup for hip replacement) manufactured using an additive process. Therefore, the requested information regarding AI/ML device acceptance criteria and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) is not applicable to this submission.
The "PERFORMANCE DATA" section (Page 5) explicitly states:
- SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE: This lists various engineering and material tests (e.g., drawing comparison, surface finish, tensile testing, corrosion testing, hardness testing, functional fatigue testing, pyrogenicity testing). These are standard tests for physical implants to ensure material properties and mechanical performance.
- SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION: It explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence."
In summary, none of the requested information about acceptance criteria and studies for an AI/ML device is present in this document because the device in question is a physical orthopedic implant, not an AI/ML diagnostic or therapeutic tool.
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June 16, 2022
DePuy International, Ltd % Reily Inman Regulatory Affairs Program Lead DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K201348
Trade/Device Name: DePuy 3D Additive TriFlange Acetabular Cup 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: June 9, 2022 Received: June 10, 2022
Dear Reily Inman:
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 medical devices and radiation-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, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201348
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 bone loss is present in the acetabular region
-
- Pelvic discontinuities
Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
(As required by 21 CFR 807.92)
| Submitter Information | ||
|---|---|---|
| Name | DePuy International Ltd | |
| Address | St. Anthony's RoadLeedsUnited Kingdom LS11 8DT | |
| Phone number | 574-453-7014 | |
| Establishment RegistrationNumber | 8010379 | |
| Name of contact person | Reily Inman | |
| Date prepared | June 16, 2022 | |
| Name of device | ||
| Trade or proprietaryname | DePuy 3D Additive TriFlange Acetabular Cup | |
| 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 ornonporous uncemented prosthesis | |
| Class | II | |
| Classification panel | 87 Orthopedics | |
| Regulation | 21 CFR 888.3358, 888.3353 | |
| Product Code(s) | LPH, MEH | |
| Legally marketeddevice(s) to whichequivalence is claimed | DePuy TriFlange II Acetabular Cup System (K040383) | |
| Reason for 510(k)submission | New manufacturing method - The subject devices are manufactured byadditive manufacturing | |
| Device description | The 3D Additive TriFlange Acetabular Cup is a patient-specific cupsystem designed and manufactured to match the individual patient'sanatomy. The system consists of a porous coated acetabular cup withthree patient-specific ilial, ischial and pubic flanges. The cup ismanufactured via additive manufacturing technology using Ti6Al4V ELIpowder, followed by traditional finishing operations. The cups may have | |
| hydroxyapatite (HA) coating. The cups are intended for cementless useonly. | ||
| Intended Use | Total hip arthroplasty | |
| Indications for use | The TriFlange Hip Prosthesis is indicated in the following conditions:1. Where bone loss is present in the acetabular region2. Pelvic discontinuitiesPorous-coated TriFlange Hip Prostheses are indicated for cementlessapplications. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICECOMPARED TO THE PREDICATE DEVICE | ||
|---|---|---|
| Characteristics | Subject Device:DePuy 3d Additive TriFlangeAcetabular Cup | Predicate Device:DePuy TriFlange II Acetabular CupSystem(K040383) |
| Intended Use | Total hip arthroplasty | Same |
| Material | Ti6Al4V with Porocoat, with andwithout plasma sprayed HAcoating | Same |
| Fixation | Uncemented | Same |
| Cup Sizes | 66mm OD only | 48mm OD to 66mm OD |
| Flange Sizes | Patient specific within specifiedlimits | Same |
| Sterile Method | Gamma | Same |
| Packaging | Double PETG blister with Tyvekpeel lid | Same |
| Shelf Life | 12 months | 5 years |
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
- Drawing comparison verification
- Surface finish testing in accordance with ISO 4288 .
- . Tensile testing in accordance with BS EN ISO 6892-1: 2011
- Corrosion testing in accordance with ASTM G3-14 and ASTM G5-14
- . Hardness testing in accordance with ASTM E18-16
- . Functional fatigue testing
- Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ● ANSI/AAMI ST-72: 2011
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 3D Additive TriFlange devices are substantially equivalent to the predicate DePuy TriFlange II Acetabular Cup System.
K201348 Page 3 of 3
§ 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.