(267 days)
Total hip replacement or hip arthroplasty is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
- Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
- 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.
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.
The document describes a 510(k) premarket notification for the DePuy Corail AMT Hip Prosthesis, which is a medical device. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (DePuy Corail AMT Hip Prosthesis K123991) and includes additional sizes, neck angles, and neck offsets as a line extension.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabular format for the device's overall performance. Instead, it lists non-clinical tests conducted for determination of substantial equivalence, implying that compliance with these test standards is the performance criteria. The reported performance is that the device passed these tests, indicating it met the requirements of each standard.
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Neck fatigue testing in accordance with ISO 7206-6:1992 | Passed / Compliant |
| Distal fatigue testing in accordance with ISO 7206-4:2010 | Passed / Compliant |
| Validation of taper dimension | Passed / Compliant |
| Validation of taper to head and neck to head dimension | Passed / Compliant |
| Range of motion in accordance with ISO 21535:2007 | Passed / Compliant |
| Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST72:2011 | Passed / Compliant |
| 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 | Passed / Compliant |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to non-clinical (laboratory) testing, not clinical studies with patients. Therefore, the concept of a "test set" in the context of patient data, data provenance, or retrospective/prospective data does not apply here. The sample sizes for the mechanical and material tests (e.g., number of hip stems tested for fatigue) are not specified in the provided summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question pertains to clinical studies and the establishment of ground truth by human experts. Since no clinical tests were conducted for substantial equivalence, this information is not applicable and thus not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical tests with patient data were performed, there was no "test set" requiring expert adjudication. This information is not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The device described is a hip prosthesis, a physical implant. It is not an AI/software device that would involve human readers or MRMC studies to assess improvement with AI assistance. Therefore, this information is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of an algorithm without human intervention, which is relevant for AI/software devices. The DePuy Corail AMT Hip Prosthesis is a physical medical device, not an algorithm. Therefore, this information is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the respective ISO, ASTM, and ANSI/AAMI standards. The device's components (neck, distal region, taper, coating) were tested against the performance parameters defined by these engineering and material standards.
8. The sample size for the training set
This question is typically relevant for machine learning or AI models, where a "training set" of data is used to develop the algorithm. Since the device is a physical hip prosthesis and its substantial equivalence was determined through non-clinical (mechanical and material) testing, there is no "training set" in this context.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this information is not applicable.
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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 & 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
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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
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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:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:
-
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
-
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
-
- Avascular necrosis of the femoral head.
-
- Non-union of femoral neck fractures.
-
- Certain high subcapital and femoral neck fractures in the elderly.
-
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
-
- 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) |
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510(K) SUMMARY
(As required by 21 CFR 807.92)
| Submitter Information | |
|---|---|
| Name | DePuy (Ireland) |
| Address | LoughbergRingaskiddyCork, Ireland |
| Phone number | 353 21 491 400 |
| Fax number | |
| Establishment RegistrationNumber | 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 nonporousuncemented prosthesisHip joint femoral (hemi-hip) metallic cemented or uncemented prosthesisHip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3353, 888.3360, 888.3390 |
| Product Code(s) | LZO, MEH, KWL, KWY |
| Legally marketeddevice(s) to whichequivalence 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 additionalsizes to allow surgeons more flexibility in the choice of stem sizes, neckangles, and neck offsets. |
| Device description | The DePuy Corail AMT hip stems are manufactured from forged titaniumalloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating forbone fixation. The stem consists of a wide range of stem neck designs andsizes allowing an accurate anatomical match for each patient. Corail AMT |
| stems are available with or without a collar, with various neck angles, andwith various neck offsets. The stems are compatible with both unipolar andbipolar heads intended for hip hemi-arthroplasty and with modular femoralheads intended for total hip arthroplasty. | |
| Intended use of thedevice | Total hip arthroplasty and hemi-hip arthroplasty |
| Indications for use | Total hip replacement or hip arthroplasty is indicated in the followingconditions: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, internalfixation, arthrodesis, hemi-arthroplasty, surface replacementarthroplasty, or total hip replacement.5. Certain cases of ankyloses.Partial hip replacement or hip hemi-arthroplasty is indicated in thefollowing conditions:1. Acute fracture of the femoral head or neck that cannot beappropriately reduced and treated with internal fixation.2. Fracture dislocation of the hip that cannot be appropriately reducedand 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 theacetabulum does not require replacement.7. Pathology involving only the femoral head/neck and/or proximalfemur that can be adequately treated by hip hemi-arthroplasty.HA coated stems of the Corail Hip system are indicated for cementless useonly. |
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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristics | Subject Device:DePuy Corail AMTHip Prosthesis | Predicate Device:DePuy Corail AMTHip Prosthesis(K123991) | Reference Device:DePuy Corail HipSystem, Revision Stem(K093736) |
|---|---|---|---|
| Intended Use | Total Hip Arthroplasty,Hemi-Hip Arthroplasty | Same | Total Hip Arthroplasty |
| Material | Ti6Al4V with plasmasprayed 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 blisterwith 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
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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.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
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.(b)
Classification. Class II.