DePuy Corail AMT Hip Prosthesis

K192946 · DePuy Orthopaedics, Inc. · LZO · Nov 26, 2019 · Orthopedic

Device Facts

• Record ID: K192946
• Device Name: DePuy Corail AMT Hip Prosthesis
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 26, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Total hip arthroplasty and hemi-hip arthroplasty

Device Story

The DePuy Corail AMT Hip Prosthesis is a femoral stem implant used in total or hemi-hip arthroplasty. The device is a forged titanium alloy (Ti6Al4V) stem, plasma-sprayed with a hydroxyapatite (HA) coating to facilitate bone fixation. It is available in various neck designs, sizes, angles, and offsets to match patient anatomy. The device is implanted by an orthopedic surgeon during hip replacement surgery. It functions as a structural replacement for the femoral head/neck, providing a stable interface for bone ingrowth via the HA coating. The current submission supports manufacturing and sterilization at an alternate facility and minor packaging modifications. The device is intended for cementless use.

Clinical Evidence

No clinical tests were conducted to demonstrate substantial equivalence. Evidence is based on non-clinical bench testing.

Technological Characteristics

Material: Forged titanium alloy (Ti6Al4V) with plasma-sprayed hydroxyapatite (HA) coating. Fixation: Uncemented. Sterilization: Gamma radiation. Packaging: Inner pouch and outer PETG blister with Tyvek peel lid. Shelf life: 5 years.

Indications for Use

Indicated for total hip replacement or arthroplasty in patients with severe pain/disability from osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic femoral head/neck fracture, failed previous hip surgery, or ankyloses. Also indicated for hemi-arthroplasty in patients with acute femoral head/neck fracture, fracture dislocation, avascular necrosis, non-union of femoral neck fractures, high subcapital/femoral neck fractures in the elderly, degenerative arthritis of the femoral head, or proximal femur pathology. HA coated stems are for cementless use only.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• DePuy Corail AMT Hip Prosthesis (K042992)
• DePuy Corail AMT Hip Prosthesis (K070554)
• DePuy Corail AMT Hip Prosthesis (K093736)
• DePuy Corail AMT Hip Prosthesis (K123991)
• DePuy Corail AMT Hip Prosthesis (K173960)

Reference Devices

• DePuy Corail Hip System, Revision Stem (K093736)

Submission Summary (Full Text)

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November 26, 2019

DePuy Orthopaedics, Inc. % Susan Mullane Regulatory Affairs Project Leader DePuy (Ireland) Loughbeg, Ringaskiddy CORK, P43ED82 IRELAND

Re: K192946

Trade/Device Name: DePuy Corail AMT Hip Prosthesis Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, MEH, KWL, KWY, Dated: October 17, 2019 Received: October 18, 2019

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 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.

for

Vesa Vuniqi 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) K192946

Device Name DePuy Corail AMT Hip Prosthesis

#### Indications for Use (Describe)

Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip 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, arthrodesis, hemi-arthroplasty, surface

replacement arthroplasty, or total hip replacement.

5. Certain cases of ankyloses.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation.

2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.

3. Avascular necrosis of the femoral head.

4. Non-union of femoral neck fractures.

5. Certain high subcapital and femoral neck fractures in the elderly.

6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.

7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.

HA coated stems of the Corail Hip system are indicated for cementless use only.

Type of Use (Select one or both, as applicable)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY

(As required by 21 CFR 807.92 and 21 CFR 807.93)

| Submitter Information | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | DePuy Ireland Ltd. |
| Address | Loughbeg, |
| | Ringaskiddy, |
| | Co.Cork, Ireland |
| Phone number | 00 353 21 4914110 |
| Fax number | N/A |
| Establishment Registration # | 9616671 |
| Name of contact person | Susan Mullane |
| Date prepared | 15 October 2019 |
| Name of device | |
| Trade or proprietary name | DePuy Corail AMT Hip Prosthesis |
| Common or usual name | Uncemented hip prosthesis |
| Classification name | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis<br>Hip joint femoral (hemi-hip) metallic cemented or uncemented<br>prosthesis<br>Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented<br>prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.5535, 888.3360, 888.3390 |
| Product Code(s) | LZO, MEH, KWL, KWY |
| Legally marketed device(s)<br>to which equivalence is<br>claimed | DePuy Corail AMT Hip Prosthesis (K042992, K070554, K093736,<br>K123991, K173960) |
| Reason for 510(k)<br>submission | The purpose of this submission is to support the manufacturing and<br>sterilization of the subject, Hydroxyapatite (HA) coated DePuy Corail<br>AMT Hip Prosthesis components at an alternate manufacturing and<br>sterilization facility. The packaging has been slightly modified. There<br>are no other modifications associated with this product in comparison<br>with the currently marketed predicate DePuy Corail AMT Hip<br>Prosthesis – the predicate and proposed devices share the same intended<br>use, product design, principle of operation, and materials. |
| Device description | The DePuy Corail AMT hip stem family are manufactured from<br>forged titanium alloy (Ti6Al4V) and plasma-sprayed with a<br>hydroxyapatite (HA) coating for bone fixation. The stem consists of a<br>wide range of stem neck designs and sizes allowing an accurate<br>anatomical match for each patient. Corail AMT stems are available<br>with or without a collar, with various neck angles, and with various<br>neck offsets. |
| Intended use of the device | Total hip arthroplasty and hemi-hip arthroplasty |
| Indications for use | Total hip replacement or hip arthroplasty is indicated in the<br>following conditions:<br><br>A severely painful and/or disabled joint from osteoarthritis, traumatic<br>arthritis, rheumatoid arthritis, or congenital hip dysplasia.<br><br>1. Avascular necrosis of the femoral head.<br>2. Acute traumatic fracture of the femoral head or neck.<br>3. Failed previous hip surgery including joint reconstruction,<br>internal fixation, arthrodesis, hemi-arthroplasty, surface<br>replacement arthroplasty, or total hip replacement. |
| | 4. Certain cases of ankyloses. |
| | Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions: |
| 1. | Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. |
| 2. | Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. |
| 3. | Avascular necrosis of the femoral head. |
| 4. | Non-union of femoral neck fractures. |
| 5. | Certain high subcapital and femoral neck fractures in the elderly. |
| 6. | Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. |
| 7. | Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty. |
| | HA coated stems of the Corail Hip system are indicated for cementless use only. |

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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE | | | | | | |
|----------------------------------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| PREDICATE DEVICE | | | | | | |
| Characteristics | Subject<br>Device:<br>DePuy Corail<br>AMT Hip<br>Prosthesis | Predicate<br>Device:<br>DePuy Corail<br>AMT Hip<br>Prosthesis<br>(K123991) | Predicate<br>Device:<br>DePuy Corail<br>AMT Hip<br>Prosthesis<br>(K123991) | Reference<br>Device:<br>DePuy Corail<br>Hip System,<br>Revision Stem<br>(K093736) | Predicate<br>Device:<br>DePuy Corail<br>AMT Hip<br>Prosthesis<br>(K070554) | Predicate<br>Device:<br>DePuy Corail<br>AMT Hip<br>Prosthesis<br>(K042992) |
| Intended Use | Total Hip<br>Arthroplasty,<br>Hemi-Hip<br>Arthroplasty | Same | Same | Total Hip<br>Arthroplasty | Total Hip<br>Arthroplasty | Total Hip<br>Arthroplasty |
| Material | Ti6Al4V with<br>plasma sprayed<br>HA coating | Same | Same | Same | Same | Same |
| Fixation | Uncemented | Same | Same | Same | Same | Same |
| Sterile Method | Gamma | Same | Same | Same | Same | Same |
| Packaging | Inner Pouch and<br>outer PETG<br>blister with<br>Tyvek peel lid | Double PETG<br>blister with<br>Tyvek peel lid | Double PETG<br>blister with<br>Tyvek peel lid | Double PETG<br>blister with<br>Tyvek peel lid | Double PETG<br>blister with<br>Tyvek peel lid | Double PETG<br>blister with<br>Tyvek peel lid |

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| Shelf Life | 5 years | Same | Same | Same | Same | Same |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|------|------|------|
| PERFORMANCE DATA | | | | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | | | | | | |
| THE FOLLOWING TESTS WERE PERFORMED ON THE DEPUY CORAIL AMT HIP PROSTHESIS TO DEMONSTRATE<br>SUBSTANTIAL EQUIVALENCE OF SAFETY AND EFFICACY WITH THE PREDICATE DEVICES: | | | | | | |
| • | BIOLOGICAL SAFETY PER ISO 10993-1 "BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 1:<br>EVALUATION AND TESTING". | | | | | |
| • | STERILIZATION VALIDATION PER AAMI ANSI ISO 11137-1: 2006/(R)2010 AND AAMI ANSI ISO 11137-2: 2013 | | | | | |
| • | CHARACTERIZATION TESTING OF HYDROXYAPATITE COATING AS RECOMMENDED PER FDA GUIDANCE:<br>"510(K) INFORMATION NEEDED FOR HYDROXYAPATITE COATED ORTHOPEDIC IMPLANT” | | | | | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE<br>AND/OR OF CLINICAL INFORMATION | | | | | | |
| NO CLINICAL TESTS WERE CONDUCTED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE. | | | | | | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | | | | | | |
| THE SUBJECT DEPUY CORAIL AMT HIP PROSTHESIS PRODUCTS ARE SUBSTANTIALLY EQUIVALENT TO THE<br>PREDICATE DEPUY CORAIL AMT HIP PROSTHESIS PRODUCTS ((K042992, K070554, K093736, K123991, K173960)) | | | | | | |