(461 days)
Not Found
No
The summary describes a mechanical orthopedic implant and its materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device, a revision stem for total hip arthroplasty, is used to treat painful and/or disabled joints and conditions like avascular necrosis, directly addressing a medical condition to restore or improve the function of the human body.
No
The device is an orthopedic implant (a hip stem) used in surgical procedures to replace a damaged hip joint. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a "modular prosthesis system for use in total hip replacement" and describes physical components like "titanium alloy hip stems" and "hydroxyapatite powders." This indicates a physical medical device, not software only.
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 treating various conditions of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (a hip stem) made of titanium alloy with a coating. This is consistent with a surgical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on bench testing and coating characterization, which are relevant to the mechanical and material properties of a surgical implant, not the analytical performance of a diagnostic test.
In summary, the DePuy Corail Revision Stem is a surgical implant intended for use within the human body to replace a damaged hip joint. This falls under the category of a medical device, but specifically a therapeutic/surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Corail Revision Stem is indicated for cementless use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting 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 surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
The subject Corail Revision Stem is intended for cementless use as part of the femoral component in a total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
KWA, LZO, MEH, LWJ
Device Description
The Corail Revision Stem is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral heads which articulate with DePuy acetabular systems with either a metal or UHMPE liner. The Corail Hip System, Revision Stem is a line addition to the Corail hip stem family. The stems are available in 9 lengths in sizes 10-20 in standard and high-off versions. The subject titanium alloy hip stems are monolithic, grit blasted stems plasma sprayed with hydroxyapatite powders on the entire stem length. The stems feature a 12/14 AMT (Articul/eze Mini Taper) Taper trunnion which are compatible with previously cleared metal and ceramic DePuy femoral heads with corresponding 12/14 tapers and offsets up to +13 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head, hip joint
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 testing and analysis were provided, including bench testing and coating characterization. Bench testing included Range of Motion, proximal fatigue and ceramic head compatibility testing. The nonporous, calcium phosphate coating was applied by plasma spraying to a nominal thickness of 155 ± 35 microns from hydroxyapatite powders. The calcium phosphate coating is applied by a different vendor and was characterized per FDA's "510(k) Information needed for Hydroxyapatite Coated Orthopedic Implants." All of the observed results indicate that the Corail Revision Hip System is substantially equivalent to devices currently marketed. Therefore, the subject device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.
No clinical testing was required to demonstrate substantial equivalence.
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.
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
长 093736
510 (k) Summary
:
:
MAR 1 0 2011
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer
Senior Regulatory Affairs Associate
Telephone: (574) 371-4927
Facsimile: (574) 371-4987
Electronic Mail: Rmyer7@its.jnj.com |
| DATE PREPARED: | March 1, 2011 |
| PROPRIETARY NAME: | DePuy Corail® Hip System, Revision Stem |
| COMMON NAME: | Hydroxyapatite-coated hip prosthesis |
| CLASSIFICATION: | Class III per 21 CFR 888.3330: Hip joint
metal/metal semi-constrained, with an
uncemented acetabular component, prosthesis
(KWA)
Class II per 21 CFR 888.3353: Hip joint
metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis
(LZO)
Class II per 21 CFR 888.3353: Hip joint
metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis
(MEH)
Class II per 21 CFR 888.3360: Hip joint
femoral (hemi-hip) metallic cemented or
uncemented prosthesis (LWJ) |
| DEVICE PRODUCT CODE AND
DESCRIPTION: | KWA: prosthesis, hip, semi-constrained (metal
uncemented acetabular component)
LZO: prosthesis, hip, semi-constrained,
metal/ceramic/polymer, cemented or non-porous,
uncemented
MEH: prosthesis, hip, semi-constrained,
uncemented, metal/polymer, non-porous,
calcium-phosphate
LWJ: prosthesis, hip, semi-constrained,
metal/polymer, uncemented |
リ
1
SUBSTANTIALLY EQUIVALENT DEVICES:
DePuy Corail Hip Stem, K042992 DePuy KAR™ Hip Stem, K961732
DEVICE DESCRIPTION:
The Corail Revision Stem is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral heads which articulate with DePuy acetabular systems with either a metal or UHMPE liner. The Corail Hip System, Revision Stem is a line addition to the Corail hip stem family. The stems are available in 9 lengths in sizes 10-20 in standard and high-off versions. The subject titanium alloy hip stems are monolithic, grit blasted stems plasma sprayed with hydroxyapatite powders on the entire stem length. The stems feature a 12/14 AMT (Articul/eze Mini Taper) Taper trunnion which are compatible with previously cleared metal and ceramic DePuy femoral heads with corresponding 12/14 tapers and offsets up to +13 mm.
INDICATIONS AND INTENDED USE:
Indications:
The DePuy Corail Revision Stem is indicated for cementless use in the treatment of:
- I. A severely painful and/or a severely disabled joint resulting 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 surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
Intended Use:
The subject Corail Revision Stem is intended for cementless use as part of the femoral component in a total hip arthroplasty.
Summary of Technologies/Substantial Equivalence:
The substantial equivalence of the subject Corail Revision Stem is demonstrated by similarities in intended use, indications for use, materials, geometry, design and performance as compared to the predicate devices. The changes presented in this 510(k) do not present new issues of safety or effectiveness as the technological characteristics are basically the same as the predicates. Based on the materials, geometry, mechanical testing and indications for use, the DePuy Corail Revision Hip System is considered to be substantially equivalent to the predicate devices.
Non-clinical Testing:
2
Non-clinical testing and analysis were provided, including bench testing and coating characterization. Bench testing included Range of Motion, proximal fatigue and ceramic head compatibility testing. The nonporous, calcium phosphate coating was applied by plasma spraying to a nominal thickness of 155 ± 35 microns from hydroxyapatite powders. The calcium phosphate coating is applied by a different vendor and was characterized per FDA's "510(k) Information needed for Hydroxyapatite Coated Orthopedic Implants." All of the observed results indicate that the Corail Revision Hip System is substantially equivalent to devices currently marketed. Therefore, the subject device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.
Clinical Testing:
No clinical testing was required to demonstrate substantial equivalence.
Conclusion:
The subject Corail Revision Stem is substantially equivalent to the predicate devices identified in this premarket notification.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Orthopaedics. Inc. % Ms. Rhonda Myer Senior Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
MAR 1 0 2011
Re: K093736
Trade/Device Name: DePuy Corail Hip System, Revision Stem 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, LWJ Dated: February 17, 2011 Received: February 18, 2011
ቦ
Dear Ms. Myer:
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
4
Page 2 -- Ms. Rhonda Myer
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
A.S. B. r2 h
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
093736 510 (k) Number (if known):
Device Name: DePuy Corail® Hip System, Revision Stem
Indications for Use:
The DePuy Corail Revision Stem is indicated for cementless use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or 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 arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
| 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.)
(Division Sign Off) for M. Melkerson
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093736
DePuy Orthopaedics, Inc.
Corail Hip System, Revision Stem Traditional 510(k)
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