(109 days)
Not Found
No
The document describes a physical hip prosthesis and its materials, intended use, and mechanical testing. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a hip prosthesis, which is used to replace a joint and alleviate pain and disability caused by various conditions, thus providing a therapeutic benefit to the patient.
No
This device is a hip prosthesis, which is an implant used for hip replacement surgery. It is a treatment device, not a diagnostic one. Its purpose is to replace damaged hip joints, not to identify or diagnose medical conditions.
No
The device description clearly states the device is a physical hip prosthesis made from titanium alloy with coatings, indicating it is a hardware medical device, not software-only.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a hip prosthesis, intended for surgical implantation to replace a damaged hip joint. This is an implantable medical device, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information. The device's function is purely mechanical and structural.
Therefore, this device falls under the category of 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, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- 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.
The DePuy Actis DuoFix Hip Prosthesis is indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LPH, KWL, KWY
Device Description
The DePuy Actis DuoFix Hip prostheses are manufactured from forged titanium alloy (Ti6Al4V) and have a sintered commercially pure titanium bead porous coating (Porocoat®) and thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hemi-arthroplasty and with modular metal and ceramic 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
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)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Neck fatigue testing in accordance with ISO 7206-6:2013
Distal fatigue testing in accordance with ISO 7206-4:2010
Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST-72:2011
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2016
DePuy (Ireland) % Ms. Correne Ramy Project Leader, Regulatory Affairs Depuy Orthopaedics, Incorporated 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K160907 Trade/Device Name: DePuy Actis DuoFix 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: MEH, LPH, KWL, KWY Dated: June 10, 2016 Received: June 13, 2016
Dear Ms. Ramy:
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
1
(21 CFR Part 807); labeling (21 CFR Parts 801); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ReportaProblem/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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
K160907 510 (k) Number (if known): _
Device Name: DePuy Actis DuoFix Hip Prosthesis
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.
-
- 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.
The DePuy Actis DuoFix Hip Prosthesis is indicated for cementless use only.
Prescription Use Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
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Section 5: 510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | ||
|---|---|---|
| Name | DePuy Orthopaedics | |
| Address | 700 Orthopedic Drive | |
| Warsaw, IN 46582 | ||
| Phone number | 574-371-4981 | |
| Fax number | 574-371-4987 | |
| Establishment Registration | ||
| Number | 1818910 | |
| Name of contact person | Correne Ramy | |
| Date prepared | March 31, 2016 | |
| Name of device | ||
| Trade or proprietary name | DePuy Actis DuoFix Hip Prosthesis | |
| Common or usual name | MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non- | |
| porous, calicum-phosphate | ||
| LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented | ||
| KWL - prosthesis, hip, hemi-, femoral, metal | ||
| KWY - prosthesis, hip, hemi-, femoral, metal/polymer, cemented or | ||
| uncemented | ||
| Classification name | MEH - Hip joint metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis | ||
| LPH - Hip joint metal/polymer/metal semi-constrained porous-coated | ||
| uncemented prosthesis | ||
| KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented | ||
| prosthesis | ||
| KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented | ||
| prosthesis | ||
| Class | II | |
| Classification panel | 87 Orthopedics | |
| Regulation | 21 CFR 888.3353, 888.3358, 888.3360, 888.3390 | |
| Product Code(s) | MEH, LPH, KWL, KWY | |
| Legally marketed device(s) to | ||
| which equivalence is claimed | DePuy Actis DuoFix Hip Prosthesis (K150862, cleared September 25, 2015) | |
| Reason for 510(k) submission | Line extension of an additional smaller size hip stem | |
| Device description | The DePuy Actis DuoFix Hip prostheses are manufactured from forged | |
| titanium alloy (Ti6Al4V) and have a sintered commercially pure titanium bead | ||
| porous coating (Porocoat®) and thin layer of plasma-sprayed hydroxyapatite | ||
| (HA) coating. The stem consists of a wide range of stem neck designs and sizes | ||
| allowing an accurate anatomical match for each patient. The stems are | ||
| compatible with both unipolar and bipolar heads intended for hemi-arthroplasty | ||
| and with modular metal and ceramic 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: | ||
| 1. A severely painful and/or disabled joint from osteoarthritis, | ||
| traumatic arthritis, rheumatoid arthritis, or congenital hip | ||
| dysplasia. | ||
| 2. Avascular necrosis of the femoral head. | ||
| 3. Acute traumatic fracture of the femoral head or neck. | ||
| 4. Certain cases of ankylosis. | ||
| 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. | ||
| The DePuy Actis DuoFix Hip Prosthesis is indicated for cementless use | ||
| only. |
4
5
| | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE
PREDICATE DEVICE | |
|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------|
| Characteristics | Subject Device: | Predicate Device: |
| | DePuy Actis DuoFix Hip Prosthesis | DePuy Actis DuoFix Hip Prosthesis
(K150862) |
| Intended Use | Total Hip Arthroplasty, Hemi-Hip
Arthroplasty | Same |
| Material | Ti6AL4V with Porocoat and plasma sprayed
HA coating | Same |
| Fixation | Uncemented | Same |
| Stem Size | 0 | 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| Neck Offset | Standard, High | Same |
| Collar | Collared | Same |
| Sterile Method | Gamma | Same |
| Packaging | Inner nylon pouch and outer PETG blister
with Tyvek peel lid | Same |
| Shelf Life | 10 years | Same |
| PERFORMANCE DATA | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE | | |
| Neck fatigue testing in accordance with ISO 7206-6:2013 | | |
| Distal fatigue testing in accordance with ISO 7206-4:2010 | | |
| Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST-
72:2011 | | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | |
| No clinical tests were conducted to demonstrate substantial equivalence. | | |
6
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject devices are substantially equivalent to the predicate DePuy Actis DuoFix Hip Prosthesis.