(196 days)
No
The document describes a mechanical hip prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an artificial hip prosthesis used in total hip arthroplasty to reduce pain and increase mobility in patients with damaged hip joints, fitting the definition of a therapeutic device.
No
The device is a hip prosthesis, an implant used in total hip arthroplasty to replace a damaged hip joint, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "collarless, hydroxyapatite coated titanium alloy femoral stem," which is a physical implant, not software.
No, 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 provided text clearly describes a hip prosthesis, which is an implantable medical device used to replace a damaged hip joint. Its intended use is for total hip arthroplasty (hip replacement surgery).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The device is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) use. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The non-porous Corail AMT Hip Stem is indicated for cementless use only.
Product codes
LZO, MEH, KWA
Device Description
The Corail AMT Hip Prosthesis is a collarless, hydroxyapatite coated titanium alloy femoral stem. The Corail AMT Hip Prosthesis is similar to the previously cleared Corail AMT Hip Prostheses but has a shorter stem length, shorter neck length and smaller cross-section. The Corail AMT Hip Prostheses is contraindicated in patients weighing more than 84 lbs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
The Corail AMT Hip Prostheses is contraindicated in patients weighing more than 84 lbs.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
SUMMARY OF SAFETY AND EFFECTIVENESS
SEP 1 1 2007
| NAME OF FIRM: | DePuy France S.A.
7 Allee Irene Joliot Curie
69801 Saint Priest cedex
France
Establishment Registration Number: 9007981 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Kathy Harris
Director, Regulatory Affairs
Tel: (574) 372-7082
Fax: (574) 371-4987 |
| TRADE NAME: | DePuy Corail AMT™ Hip Prosthesis |
| COMMON NAME: | Hip Stem |
| CLASSIFICATION: | 21 CFR 888.3330: Hip joint metal / metal semi-constrained
prosthesis, with an uncemented acetabular component; Class III
21 CFR 888.3353: Hip joint metal / ceramic / polymer semi-
constrained cemented or nonporous uncemented prosthesis; Class III |
DEVICE PRODUCT CODES: LZO, MEH, KWA
| SUBSTANTIALLY | |
|---|---|
| EQUIVALENT DEVICES: | DePuy Corail AMT Hip Prosthesis (K042992) |
| DePuy S-Rom Femoral Hip Stem, Size 12 x 06 x 115 | |
| (K961939) |
DEVICE DESCRIPTION:
The Corail AMT Hip Prosthesis is a collarless, hydroxyapatite coated titanium alloy femoral stem. The Corail AMT Hip Prosthesis is similar to the previously cleared Corail AMT Hip Prostheses but has a shorter stem length, shorter neck length and smaller cross-section. The Corail AMT Hip Prostheses is contraindicated in patients weighing more than 84 lbs.
INDICATIONS FOR USE:
The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) use. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
1
-
- 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The non-porous Corail AMT Hip Stem is indicated for cementless use only.
BASIS FOR SUBSTANTIAL EQUIVALENCE:
The Corail AMT Hip Prosthesis is a modification of the Corail AMT Hip Prostheses that were cleared in K042992. Based on similarities in indications, intended use, design, materials, method of manufacture and the results of fatigue testing, DePuy believes that the Corail AMT Hip Prosthesis is substantially equivalent to the previously cleared Corail AMT Hip Prostheses.
2
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 2007
DePuy Orthopaedics, Inc. % Ms. Kathy Harris Director, Regulatory Affairs P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K070554
Trade/Device Name: Corail AMT Hip Prosthesis Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LZO, MEH Dated: August 13, 2007 Received: August 16, 2007
Dear Ms. Harris:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Kathy Harris
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. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Mehm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ____K070554
Device Name: DePuy Corail AMT Hip Prosthesis
The Corail AMT Hip Prosthesis is intended for use in total hip arthroplasty and is intended for press fit (uncemented) use. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The non-porous Corail AMT Hip Stem is indicated for cementless use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oubou Buelund fompon
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
Neurological Devices
51000 V. K070554
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