Who is the manufacturer of DePuy Corail AMT Hip Prosthesis?

Depuy(Ireland) filed the 510(k) submission for DePuy Corail AMT Hip Prosthesis (K190344).

What is the FDA product code for DePuy Corail AMT Hip Prosthesis?

LZO. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for DePuy Corail AMT Hip Prosthesis?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DePuy Corail AMT Hip Prosthesis?

DePuy Corail AMT Hip Prosthesis (K173960); DePuy Corail AMT Hip Prosthesis (K123991).

Who can help prepare an FDA 510(k) submission like DePuy Corail AMT Hip Prosthesis?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DePuy Corail AMT Hip Prosthesis

K190344 · Depuy(Ireland) · LZO · Nov 1, 2019 · Orthopedic

Device Facts

Record ID	K190344
Device Name	DePuy Corail AMT Hip Prosthesis
Applicant	Depuy(Ireland)
Product Code	LZO · Orthopedic
Decision Date	Nov 1, 2019
Decision	SESE
Submission Type	Traditional
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 line extension of an existing uncemented hip stem system. It consists of forged titanium alloy (Ti6Al4V) femoral stems plasma-sprayed with hydroxyapatite (HA) for bone fixation. The device is used by orthopedic surgeons in a clinical/OR setting to replace the femoral head/neck during total hip arthroplasty or hemi-arthroplasty. The system offers various stem sizes, neck angles, and neck offsets to allow for anatomical matching. The device is implanted into the femur to restore joint function and alleviate pain caused by degenerative or traumatic hip conditions. It is compatible with both unipolar/bipolar heads for hemi-arthroplasty and modular femoral heads for total hip arthroplasty.

Clinical Evidence

No clinical tests were conducted. Substantial equivalence is supported by non-clinical bench testing, including neck and distal fatigue testing (ISO 7206-6:1992, ISO 7206-4:2010), taper compatibility, range of motion (ISO 21535:2009), reamer verification, pyrogenicity (ANSI/AAMI ST72:2011), and HA coating process validation.

Technological Characteristics

Materials: Forged titanium alloy (Ti6Al4V) with plasma-sprayed hydroxyapatite (HA) coating. Fixation: Uncemented. Design: Modular femoral stems with various neck angles (125°, 135°) and offsets (Low, Standard, High). Sterilization: Gamma radiation. Packaging: Double PETG blister with Tyvek lid. Shelf life: 5 years.

Indications for Use

Indicated for patients requiring total hip replacement or hemi-arthroplasty due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head/neck, failed previous hip surgery, ankylosis, fracture dislocation, non-union of femoral neck fractures, or degenerative arthritis. 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 (K173960)
DePuy Corail AMT Hip Prosthesis (K123991)

Related Devices

K173960 — DePuy Corail AMT Hip Prosthesis · Depuy France S.A.S. · Sep 21, 2018
K213839 — DePuy Corail AMT Hip Prosthesis · DePuy Orthopaedics, Inc. · Jan 6, 2022
K192946 — DePuy Corail AMT Hip Prosthesis · DePuy Orthopaedics, Inc. · Nov 26, 2019
K123991 — DEPUY CORAIL AMT HIP PROSTHESIS · Depuy France S.A.S. · Sep 16, 2013
K093736 — DEPUY CORAIL HIP SYSTEM, REVISION STEM · DePuy Orthopaedics, Inc. · Mar 10, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ November 1, 2019 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font. DePuy (Ireland) % Melissa Cook Regulatory Affairs Specialist III DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 ## Re: K190344 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, KWL, KWY Dated: October 3, 2019 Received: October 4, 2019 ## Dear Melissa Cook: 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. 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 {1}------------------------------------------------ 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, FOR Vesa Vuniqi 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190344 #### 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, traumatoid 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 ankylosis. 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 hemiarthroplasty. HA coated stems of the Corail Hip System are indicated 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}------------------------------------------------ # 510(K) SUMMARY (As required by 21 CFR 807.92) | Submitter Information | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | DePuy (Ireland) | | Address | Loughbeg Ringaskiddy Co. Cork, Ireland | | Phone number | 574-371-4906 | | Establishment Registration Number | 9616671 | | Name of contact person | Melissa Cook | | Date prepared | February 12, 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 nonporous uncemented prosthesis Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis | | Class | II | | Classification panel | 87 Orthopedics | | Regulation | 21 CFR 888.3353, 888.3360, 888.3390 | | Product Code(s) | LZO, MEH, KWL, KWY | | Legally marketed device(s) to which equivalence is claimed | DePuy Corail AMT Hip Prosthesis (K173960, cleared September 21, 2018) DePuy Corail AMT Hip Prosthesis (K123991, cleared September 16, 2013) | | Reason for 510(k) submission | Line extension – The subject devices represent hip stems with additional sizes to allow surgeons more flexibility in the choice of stem sizes, neck angles, and neck offsets. The subject devices incorporate minor modifications to the plasma spray coating process and a labeling change. | | Device description | The DePuy Corail AMT hip stems are manufactured from forged titanium alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail AMT stems are available with or without a collar, with various neck angles and | | with various neck offsets. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-arthroplasty and with modular femoral heads intended for total hip arthroplasty. | | | 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 following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, 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, internal fixation, 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 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. | {4}------------------------------------------------ {5}------------------------------------------------ | Characteristics | Subject Device: DePuy Corail AMT Hip Prosthesis | Predicate Device: DePuy Corail AMT Hip Prosthesis (K173960) | Predicate Device: DePuy Corail AMT Hip Prosthesis (K123991) | |-----------------|-------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------| | Intended Use | Total Hip Arthroplasty, Hemi-Hip Arthroplasty | Same | Same | | Material | Ti6Al4V with plasma sprayed HA coating | Same | Same | | Fixation | Uncemented | Same | Same | | Stem Size | 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20 | Same | Same | | Neck Angle | 125° and 135° | Same | Same | | Neck Offset | Low, Standard, High | Same | Standard, High | | Collar | Collared, Collarless | Same | Same | | Sterile Method | Gamma | Same | Same | | 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 - Neck fatigue testing in accordance with ISO 7206-6:1992 ● - Distal fatigue testing in accordance with ISO 7206-4:2010 . - Taper compatibility test . - Range of motion in accordance with ISO 21535:2009 . - Reamer verification test - . Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST72:2011 - Hydroxyapatite coating process validations ● {6}------------------------------------------------ # 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 DePuy Corail AMT hip stems are substantially equivalent to the predicate DePuy Corail AMT hip stems.