Who is the manufacturer of DePuy Corail AMT Hip Prosthesis?

Depuy France S.A.S. filed the 510(k) submission for DePuy Corail AMT Hip Prosthesis (K173960).

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).

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

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

DePuy Corail AMT Hip Prosthesis (K123991).

K173960 · Depuy France S.A.S. · LZO · Sep 21, 2018 · Orthopedic

Device Facts

Record ID	K173960
Device Name	DePuy Corail AMT Hip Prosthesis
Applicant	Depuy France S.A.S.
Product Code	LZO · Orthopedic
Decision Date	Sep 21, 2018
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

DePuy Corail AMT Hip Prosthesis is a line extension of an existing hip stem system. The device consists of forged titanium alloy (Ti6Al4V) femoral stems with a plasma-sprayed hydroxyapatite (HA) coating to facilitate cementless bone fixation. The system includes various stem sizes, neck angles, and neck offsets to allow for anatomical matching during total hip arthroplasty or hemi-arthroplasty. The device is implanted by an orthopedic surgeon in a clinical setting. The stems are compatible with both unipolar and bipolar heads for hemi-arthroplasty and modular femoral heads for total hip arthroplasty. The primary benefit is providing surgeons with increased flexibility in implant selection to restore joint function and alleviate pain in patients with degenerative or traumatic hip conditions.

Clinical Evidence

No clinical tests were conducted to demonstrate substantial equivalence; the submission relies on bench testing only.

Technological Characteristics

Material: Forged Ti6Al4V titanium alloy with plasma-sprayed hydroxyapatite (HA) coating. Fixation: Cementless. Dimensions: Various stem sizes (8-20), neck angles (125°, 135°), and offsets (Low, Standard, High). Sterilization: Gamma radiation. Packaging: Double PETG blister with Tyvek lid. Shelf life: 10 years. Standards: ISO 7206-6:1992, ISO 7206-4:2010, ISO 21535:2007, ANSI/AAMI ST72:2011, ASTM F1160-05:2011, ASTM F1044-05:2011, ASTM F1147-05:2011, ASTM F1926:2010, ISO 13779-3:2008.

Indications for Use

Indicated for patients with severely painful/disabled joints due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous hip surgery (reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement, or total hip replacement); or certain cases of ankylosis. Partial hip replacement/hemi-arthroplasty indicated for acute femoral head/neck fractures not treatable by internal fixation; fracture dislocation of the hip; avascular necrosis; non-union of femoral neck fractures; high subcapital/femoral neck fractures in the elderly; degenerative arthritis of the femoral head only; or pathology of the femoral head/neck/proximal femur. 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 (K123991)

Reference Devices

DePuy Corail Hip System, Revision Stem (K093736)

Related Devices

K190344 — DePuy Corail AMT Hip Prosthesis · Depuy(Ireland) · Nov 1, 2019
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
K212069 — Corin MetaFix Hip Stem · Corin U.S.A. Limited · Apr 7, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ 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 & 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. September 21, 2018 DePuy France S.A.S. % Melissa Cook Regulatory Affairs Specialist DePuv Orthopaedics. Inc. 700 Orthopaedic Dr. Warsaw, Indiana 46582 Re: K173960 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: August 23, 2018 Received: August 24, 2018 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 {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Daniel S. Ramsey -S 2018.09.21 12:01:54 -04'00' For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173960 #### 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) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |--------------------------------------------------------------------------------------| | <input type="checkbox"/> 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 | Loughberg Ringaskiddy Cork, Ireland | | Phone number | 353 21 491 400 | | Fax number | | | Establishment Registration Number | 9616671 | | Name of contact person | Melissa Cook | | Date prepared | 23 August 2018 | | 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 (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. | | 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}------------------------------------------------ ## SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE | Characteristics | Subject Device: DePuy Corail AMT Hip Prosthesis | Predicate Device: DePuy Corail AMT Hip Prosthesis (K123991) | Reference Device: DePuy Corail Hip System, Revision Stem (K093736) | |-----------------|-------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------| | Intended Use | Total Hip Arthroplasty, Hemi-Hip Arthroplasty | Same | Total Hip Arthroplasty | | 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 | 10, 11, 12, 13, 14, 15, 16, 18, 20 | | Neck Angle | 125° and 135° | Same | 135° | | Neck Offset | Low, Standard, High | Standard, High | Standard, High | | Collar | Collared, Collarless | Same | Collared | | Sterile Method | Gamma | Same | Same | | Packaging | Double PETG blister with Tyvek peel lid | Same | Same | | Shelf Life | 10 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 - . Validation of taper dimension - o Validation of taper to head and neck to head dimension - Range of motion in accordance with ISO 21535:2007 ● - Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST72:2011 - Hydroxyapatite coating characterization, as specified by FDA Guidance 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants, in accordance with ASTM F1160-05:2011, ASTM F1044-05:2011, ASTM F1147-05:2011, ASTM F1926:2010 and ISO 13779-3:2008 {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.