(39 days)
No
The summary describes a hip implant and its materials, indications, and testing. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is a total or partial hip replacement system intended to treat conditions causing severe pain, disability, or fractures of the hip, which are therapeutic indications.
No
The device is a hip implant (prosthesis), indicated for conditions requiring hip replacement, and does not diagnose disease.
No
The device description explicitly states it is a hip stem manufactured from forged titanium alloy and plasma-sprayed with a hydroxyapatite coating, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing or partially replacing the hip joint due to various conditions affecting the bone and joint structure. This is a therapeutic and structural intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (hip stem) made of titanium alloy with a coating. This is consistent with a surgical device, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The performance studies focus on biological safety, sterilization, and coating characteristics, which are relevant to an implantable device, not an IVD.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Total hip replacement or hip arthroplasty is indicated in the following conditions:
-
A severely painful and/or disabled joint from osteoarthritis, 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 including joint reconstruction, arthrodesis, hemi-arthroplasty, surface
replacement arthroplasty, or total hip replacement. -
Certain cases of ankyloses.
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 treation.
-
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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, KWL, KWY
Device Description
The DePuy Corail AMT hip stem family 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femoral head, femoral neck, proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
NO CLINICAL TESTS WERE CONDUCTED TO DEMONSTRATE SUBSTANTIAL EQUIVALENCE.
The following non-clinical tests were performed on the DePuy Corail AMT Hip Prosthesis to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- BIOLOGICAL SAFETY PER ISO 10993-1 "BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 1: 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: "510(K) INFORMATION NEEDED FOR HYDROXYAPATITE COATED ORTHOPEDIC IMPLANT”
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K123991, K070554, K042992, K173960
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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:
-
A severely painful and/or disabled joint from osteoarthritis, 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 including joint reconstruction, arthrodesis, hemi-arthroplasty, surface
replacement arthroplasty, or total hip replacement.
- Certain cases of ankyloses.
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 treation.
-
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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3
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 |
| 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 888.5535, 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 (K042992, K070554, K093736, |
| K123991, K173960) | |
| Reason for 510(k) | |
| submission | The purpose of this submission is to support the manufacturing and |
| sterilization of the subject, Hydroxyapatite (HA) coated DePuy Corail | |
| AMT Hip Prosthesis components at an alternate manufacturing and | |
| sterilization facility. The packaging has been slightly modified. There | |
| are no other modifications associated with this product in comparison | |
| with the currently marketed predicate DePuy Corail AMT Hip | |
| Prosthesis – the predicate and proposed devices share the same intended | |
| use, product design, principle of operation, and materials. | |
| Device description | The DePuy Corail AMT hip stem family 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. | |
| 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: |
A severely painful and/or disabled joint from 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 including joint reconstruction,
internal fixation, arthrodesis, hemi-arthroplasty, surface
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. |
4
5
6
| 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) | Predicate | |||||
| Device: | ||||||
| DePuy Corail | ||||||
| AMT Hip | ||||||
| Prosthesis | ||||||
| (K123991) | Reference | |||||
| Device: | ||||||
| DePuy Corail | ||||||
| Hip System, | ||||||
| Revision Stem | ||||||
| (K093736) | Predicate | |||||
| Device: | ||||||
| DePuy Corail | ||||||
| AMT Hip | ||||||
| Prosthesis | ||||||
| (K070554) | Predicate | |||||
| Device: | ||||||
| DePuy Corail | ||||||
| AMT Hip | ||||||
| Prosthesis | ||||||
| (K042992) | ||||||
| Intended Use | Total Hip | |||||
| Arthroplasty, | ||||||
| Hemi-Hip | ||||||
| Arthroplasty | Same | Same | Total Hip | |||
| Arthroplasty | Total Hip | |||||
| Arthroplasty | Total Hip | |||||
| Arthroplasty | ||||||
| Material | Ti6Al4V with | |||||
| plasma sprayed | ||||||
| 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 | |||||
| outer PETG | ||||||
| blister with | ||||||
| Tyvek peel lid | Double PETG | |||||
| blister with | ||||||
| Tyvek peel lid | Double PETG | |||||
| blister with | ||||||
| Tyvek peel lid | Double PETG | |||||
| blister with | ||||||
| Tyvek peel lid | Double PETG | |||||
| blister with | ||||||
| Tyvek peel lid | Double PETG | |||||
| blister with | ||||||
| Tyvek peel lid |
7
| 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 | ||||||
| SUBSTANTIAL EQUIVALENCE OF SAFETY AND EFFICACY WITH THE PREDICATE DEVICES: | ||||||
| • | BIOLOGICAL SAFETY PER ISO 10993-1 "BIOLOGICAL EVALUATION OF MEDICAL DEVICES PART 1: | |||||
| 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: | |||||
| "510(K) INFORMATION NEEDED FOR HYDROXYAPATITE COATED ORTHOPEDIC IMPLANT” | ||||||
| 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 PROSTHESIS PRODUCTS ARE SUBSTANTIALLY EQUIVALENT TO THE | ||||||
| PREDICATE DEPUY CORAIL AMT HIP PROSTHESIS PRODUCTS ((K042992, K070554, K093736, K123991, K173960)) |