DePuy 3D Additive TriFlange Acetabular Cup

K201348 · Depuy International, Ltd. · LPH · Jun 16, 2022 · Orthopedic

Device Facts

• Record ID: K201348
• Device Name: DePuy 3D Additive TriFlange Acetabular Cup
• Applicant: Depuy International, Ltd.
• Product Code: LPH · Orthopedic
• Decision Date: Jun 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 bone loss is present in the acetabular region 2. Pelvic discontinuities Porous-coated TriFlange Hip Prostheses are indicated for cementless applications.

Device Story

Patient-specific acetabular cup system; designed to match individual patient anatomy; features porous-coated cup with three patient-specific flanges (ilial, ischial, pubic). Manufactured via additive manufacturing (3D printing) using Ti6Al4V ELI powder; includes traditional finishing operations; optional hydroxyapatite (HA) coating. Used by orthopedic surgeons in total hip arthroplasty procedures to address acetabular bone loss or pelvic discontinuities. Device provides structural support and fixation for modular liners; facilitates cementless implantation. Benefits include anatomical customization for complex revision or primary cases with significant bone deficiency.

Clinical Evidence

No clinical tests were conducted. Substantial equivalence is supported by non-clinical bench testing, including drawing verification, surface finish (ISO 4288), tensile testing (BS EN ISO 6892-1), corrosion testing (ASTM G3-14, ASTM G5-14), hardness testing (ASTM E18-16), functional fatigue testing, and pyrogenicity testing (ANSI/AAMI ST-72).

Technological Characteristics

Material: Ti6Al4V ELI powder; Porocoat porous coating; optional plasma-sprayed hydroxyapatite (HA). Manufacturing: Additive manufacturing. Fixation: Uncemented. Sterilization: Gamma radiation. Packaging: Double PETG blister with Tyvek lid. Standards: ISO 4288 (surface finish), BS EN ISO 6892-1 (tensile), ASTM G3-14/G5-14 (corrosion), ASTM E18-16 (hardness), ANSI/AAMI ST-72 (pyrogenicity).

Indications for Use

Indicated for patients undergoing total hip arthroplasty with acetabular bone loss or pelvic discontinuities. Indicated for cementless applications.

Regulatory Classification

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.

Predicate Devices

• DePuy TriFlange II Acetabular Cup System (K040383)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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:

- 1. Where bone loss is present in the acetabular region
- 2. 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 Road<br>Leeds<br>United Kingdom LS11 8DT | |
| Phone number | 574-453-7014 | |
| Establishment Registration<br>Number | 8010379 | |
| Name of contact person | Reily Inman | |
| Date prepared | June 16, 2022 | |
| Name of device | | |
| Trade or proprietary<br>name | DePuy 3D Additive TriFlange Acetabular Cup | |
| Common or usual name | Acetabular cup | |
| Classification name | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis<br>Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis | |
| Class | II | |
| Classification panel | 87 Orthopedics | |
| Regulation | 21 CFR 888.3358, 888.3353 | |
| Product Code(s) | LPH, MEH | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | DePuy TriFlange II Acetabular Cup System (K040383) | |
| Reason for 510(k)<br>submission | New manufacturing method - The subject devices are manufactured by<br>additive manufacturing | |
| Device description | The 3D Additive TriFlange Acetabular Cup is a patient-specific cup<br>system designed and manufactured to match the individual patient's<br>anatomy. The system consists of a porous coated acetabular cup with<br>three patient-specific ilial, ischial and pubic flanges. The cup is<br>manufactured via additive manufacturing technology using Ti6Al4V ELI<br>powder, followed by traditional finishing operations. The cups may have | |
| | hydroxyapatite (HA) coating. The cups are intended for cementless use<br>only. | |
| Intended Use | Total hip arthroplasty | |
| Indications for use | The TriFlange Hip Prosthesis is indicated in the following conditions:<br>1. Where bone loss is present in the acetabular region<br>2. Pelvic discontinuities<br><br>Porous-coated TriFlange Hip Prostheses are indicated for cementless<br>applications. | |

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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE<br>COMPARED TO THE PREDICATE DEVICE | | |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Characteristics | Subject Device:<br>DePuy 3d Additive TriFlange<br>Acetabular Cup | Predicate Device:<br>DePuy TriFlange II Acetabular Cup<br>System<br>(K040383) |
| Intended Use | Total hip arthroplasty | Same |
| Material | Ti6Al4V with Porocoat, with and<br>without plasma sprayed HA<br>coating | Same |
| Fixation | Uncemented | Same |
| Cup Sizes | 66mm OD only | 48mm OD to 66mm OD |
| Flange Sizes | Patient specific within specified<br>limits | Same |
| Sterile Method | Gamma | Same |
| Packaging | Double PETG blister with Tyvek<br>peel 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.

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