(260 days)
Not Found
No
The provided text describes a hip implant device and its indications for use. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The performance studies listed are standard mechanical and material tests for orthopedic implants.
Yes
The device is a hip implant intended to address conditions causing severe pain or disability, replace fractured or damaged bones, and restore joint function; these actions directly treat diseases or injuries, thereby providing a therapeutic effect.
No
This device is a hip implant (prosthesis), a therapeutic device used for replacement of a diseased or damaged hip joint. Its intended use is to treat existing conditions, not to diagnose them.
No
The device description clearly states it is a physical hip stem manufactured from titanium alloy with a hydroxyapatite coating, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description clearly states that this is a hip stem, a physical implant used in hip replacement surgery. The intended use describes the conditions for which this surgical procedure is indicated.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely as a prosthetic implant.
- Testing Performed: The summary of non-clinical tests focuses on mechanical properties, material compatibility, and manufacturing processes relevant to a surgical implant, not diagnostic performance.
Therefore, this device falls under the category of a surgical implant or prosthetic device, 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, KWL, KWY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-clinical tests:
- 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
Clinical tests:
No clinical tests were conducted to demonstrate substantial equivalence.
Key results: The subject DePuy Corail AMT hip stems are substantially equivalent to the predicate DePuy Corail AMT hip stems.
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.
DePuy Corail AMT Hip Prosthesis (K173960), DePuy Corail AMT Hip Prosthesis (K123991)
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.
Not Found
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
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:
-
- 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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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: |
- 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. - 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 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. |
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.