(264 days)
No
The 510(k) summary describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is a hip implant used for total or partial hip replacement, aiming to alleviate pain and restore function in diseased or damaged hip joints. This aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The described device is a hip implant (Corail AMT Hip), used for total hip arthroplasty and hemi hip arthroplasty to treat various conditions like arthritis, avascular necrosis, and fractures. It is a prosthetic device intended for surgical replacement, not for diagnosing medical conditions.
No
The device description explicitly states it is a tapered stem manufactured from titanium alloy 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the device is a "tapered stem" manufactured from titanium alloy with a coating, designed for use in hip replacement surgery. This is an implantable surgical device.
- Intended Use/Indications for Use: The indications describe conditions of the hip joint requiring surgical intervention and replacement of parts of the hip. This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant used in orthopedic procedures, not a diagnostic tool used in a laboratory setting.
N/A
Intended Use / Indications for Use
Total Hip Arthroplasty and Hemi Hip Arthroplasty
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 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.
Prescription Use X
Product codes (comma separated list FDA assigned to the subject device)
KWY, LZO, KWL
Device Description
The Corail AMT Hip is a tapered stem available both collarless and collared. The stems are manufactured from titanium alloy (Ti6Al4V) and plasma-sprayed with a biocompatible hydroxyapatite (HA) coating for bone fixation. The Corail AMT stems feature a 12/14 modular taper that accepts 12/14 heads with a wide range of diameters. The compatible components for the hip hemi-arthroplasty application are bipolar heads cleared via 510(k) K812672 and unipolar heads cleared via 510(k) K903084. Corail AMT stems are indicated for cementless use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, Femoral head or 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)
Non-clinical performance data provided:
- Validation of the taper/heads dimensional compatibility with Corail AMT Stems
- Fatigue Resistance tests for the Corail AMT Stems
Clinical tests for determination of substantial equivalence:
No clinical tests have been performed for determination of substantial equivalence.
A clinical evaluation utilizing systematic literature review of Corail Hip System for the treatment of femoral neck fractures was included. This evaluation is based on an assessment of the risks and benefits associated with the use of the device through a systematic compilation of relevant scientific literature and a critical evaluation of the identified clinical literature.
The safety and effectiveness of the Corail AMT Hip stem is supported by substantial equivalence information, materials information, review of clinical literature to support the modified indications for use, and performance test data.
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.
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.
K120362, K113242, K111193, K812672, K903084
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
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
K123991 (pg 1/3)
Section 5: 510 (k) Summary
As required by 21 CFR 807.92(c)
| Sponsor | As required by 21 CFR 807.92(c) | |
|---|---|---|
| Name | DePuy Orthopaedics France S.A.S. | |
| Address | 7 Allee Irene Joliot Curie bp256; | |
| Saint Priest Cedex, France 69801 | ||
| Phone number | +33 4 72 79 27 27 | |
| Fax number | +33 4 72 79 28 38 | |
| Establishment | ||
| Registration | ||
| Number | 3003895575 | |
| Application Correspondent | ||
| Name | DePuy Orthopaedics, Inc. | |
| Address | 700 Orthopaedic Drive | |
| Warsaw. IN 46581 | ||
| Phone number | (574)-372-7349 | |
| Fax number | (574) 371-4987 | |
| Establishment | ||
| Registration | ||
| Number | 1818910 | |
| Name of | ||
| contact person | Alma Relja, RAC | |
| Date prepared | December 19, 2012 | |
| Name of device | ||
| Trade or | ||
| proprietary | ||
| name | Corail AMTTM Hip Prosthesis | |
| Common or | ||
| usual name | Hip Stem | |
| Classification | ||
| name | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis | |
| Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous | ||
| uncemented prosthesis; Class II | ||
| Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis; Class II | ||
| Classification panel | 87 - Orthopedics Branch, Division of General and Restorative Devices | |
| Regulation | 21 CFR 888.3390; 888.3353; 8888.3360 | |
| Product Code(s) | KWY, LZO, KWL | |
| Legally marketed | ||
| device(s) to which | ||
| equivalence is | ||
| claimed | Corail AMTTM Hip Prosthesis (K070554: K042992) | |
| MetaFix Femoral Stem for Hemi-Arthroplasty (K120362) | ||
| Apex ARC Hip Stem (K113242; K111193) | ||
| Reason for 510(k) | ||
| submission | Expand currently cleared Indication for Use to add hip hemi-arthroplasty surgical | |
| application |
1
.
| Device description | The Corail AMT Hip is a tapered stem available both collarless and collared. The
stems are manufactured from titanium alloy (Ti6Al4V) and plasma-sprayed with a
biocompatible hydroxyapatite (HA) coating for bone fixation.
The Corail AMT stems feature a 12/14 modular taper that accepts 12/14 heads with a
wide range of diameters. The compatible components for the hip hemi-arthroplasty
application are bipolar heads cleared via 510(k) K812672 and unipolar heads cleared
via 510(k) K903084. Corail AMT stems are indicated for cementless use only. | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--|--|
| Intended Use | | 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 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. | | | |
| Summary of the technological characteristics of the device compared to the predicate device | | | | | |
| Characteristic | DePuy Orthopaedics Corail
AMT™ Hip Prosthesis
(subject device, predicate
devices: K070554; K042992) | MetaFix Femoral Stem
for Hemi-Arthroplasty
(K120362) | Apex ARC Hip Stem
(K113242 and K11193) | | |
| Material | Ti-6Al-4V | Same as Subject Device | Same as Subject Device | | |
| Stem Surface | plasma-sprayed with a
biocompatible hydroxyapatite
(HA) coating for bone fixation | Same as Subject Device | Same as Subject Device | | |
| Compatible
Femoral Heads | Bipolar and Unipolar | Same as Subject Device | Bipolar | | |
| Taper Design | 12/14 taper | Same as Subject Device | Same as Subject Device | | |
| Placement | Press Fit: Cementless | Same as Subject Device | Same as Subject Device | | |
| PERFORMANCE DATA | | | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE
The following non-clinical performance data is provided in this submission: | | | | | |
- Validation of the taper/heads dimensional compatibility with Corail AMT Stems
- . Fatigue Resistance tests for the Corail AMT Stems
2
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
No clinical tests have been performed for determination of substantial equivalence.
However, included in this submission is a clinical evaluation utilizing systematic literature review of Corail Hip System for the treatment of femoral neck fractures. This clinical evaluation of the subject device is based on an assessment of the risks and benefits associated with the use of the device through a systematic compilation of the relevant scientific literature currently available and a critical evaluation of the clinical literature identified.
The fundamental scientific technology of the Corail AMT Hip stem has not changed in order to expand the indications for use to add hip hemi-arthroplasty and utilize the compatible unipolar and bipolar heads. The safety and effectiveness of the subject Corail AMT Hip stem is adequately supported by the substantial equivalence information, materials information, review of clinical literature to support the modified indications for use and performance test data provided in this submission.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2013
DePuy France S.A.S % Ms. Alma Relja DePuy Orthopaedics, Incorporated 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K123991
Trade/Device Name: Corail AMT" Hip Prosthesis Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY, LZO, KWL Dated: August 14, 2013 Received: August 15, 2013
Dear Ms. Relja:
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. 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 801); medical, device reporting (reporting of medical
4
Page 2 - Ms. Alma Relja
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson - S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4: Indications for Use Statement
510 (k) Number (if known); K123991 (pg 1/1)
Device Name: Corail AMT Hip Prosthesis
Total bip replacement or hip arthroplasty is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritts, traumatic arthritis, theumatoid 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-বা 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 6. 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
Concurrence of Center for Devices and Radiological Health