(177 days)
Not Found
No
The document describes a hip prosthesis and its intended use, material, and testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a hip prosthesis, which is implanted to treat severely painful and/or disabled joints, avascular necrosis, fractures, and failed previous hip surgeries, directly addressing and alleviating these medical conditions.
No
The device description and intended use indicate that the DePuy Actis DuoFix Hip Prosthesis is an implant used for hip replacement (arthroplasty) to treat various conditions affecting the hip joint. It is a therapy device, not a diagnostic one.
No
The device description explicitly states the device is manufactured from forged titanium alloy and has a porous coating and hydroxyapatite coating, indicating it is a physical implant, not software.
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 procedure (total or partial hip replacement) to treat various conditions affecting the hip joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant (hip prosthesis) made of titanium alloy. This is a medical device used in vivo (within the body), not a reagent or instrument used in vitro (outside the body) to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
The device is a surgical implant used to replace a damaged hip joint, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
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.
- 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.
The 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 prostheses are manufactured from forged titanium alloy (Ti-6Al-4V) 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
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: Distal fatigue, neck fatigue, range of motion, biocompatibility.
Clinical tests: 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 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 image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DePuy Orthopaedics, Incorporated Correne Ramy Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582
September 25, 2015
Re: K150862 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: September 2, 2015 Received: September 4, 2015
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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
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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
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.
-
- 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.
The Actis DuoFix Hip Prosthesis is indicated for cementless use only.
| Prescription Use X | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(Please do not write below this line. Continue on another page if needed.)
3
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, 2015 | ||
| Trade or proprietary | |||
| name | DePuy Actis DuoFix Hip Prosthesis | ||
| Common or usual name | Uncemented Hip Prosthesis | ||
| Classification name | Hip joint metal/polymer/metal semi-constrained porous-coated | ||
| uncemented prosthesis | |||
| 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 888.3358, 888.3353, 888.3360, 888.3390 | ||
| Product Code(s) | LPH, MEH, KWL, KWY | ||
| Legally marketed | |||
| device(s) to which | |||
| equivalence is claimed | DePuy Summit DuoFix Hip Prosthesis (K011489, cleared July | ||
| 31, 2001) | |||
| DePuy Corail AMT Hip Prosthesis (K123991, cleared | |||
| September 16, 2013) | |||
| Reason for 510(k) | |||
| submission | New hip prosthesis | ||
| Device description | The DePuy Actis DuoFix prostheses are manufactured from | ||
| forged titanium alloy (Ti-6Al-4V) 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: |
- 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.
The Actis DuoFix Hip Prosthesis is indicated for
cementless use only. | | |
| Characteristics | Subject Device:
DePuy Actis DuoFix Hip
Prosthesis | Predicate Device:
DePuy Summit DuoFix Hip
Prosthesis (K011489) | Predicate Device:
DePuy Corail AMT Hip
Prosthesis (K123991) |
| Intended Use | Total Hip Arthroplasty,
Hemi-Hip Arthroplasty | Total Hip Arthroplasty, | Total Hip Arthroplasty
Hemi-Hip Arthroplasty |
| Material | Ti-6AL-4V with Porocoat
and plasma sprayed HA
coating | Ti-6AL-4V with Porocoat
and plasma sprayed HA
coating | Ti-6AL-4V with plasma sprayed
HA coating |
| Fixation | Uncemented | Uncemented | Uncemented |
| Stem Size | 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,
11, 12 | 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 | 6, 8, 9, 10, 11, 12, 13, 14, 15, 16,
18, 20 |
| Neck Offset | Standard, High | Standard, High | Standard, High |
| Collar | Collared | Collarless | Collared, Collarless |
| Sterile Method | Gamma | Same | Same |
| Packaging | Double PETG blister with
Tyvek peel lid | Same | Same |
| Shelf Life | 10 years | Same | Same |
| PERFORMANCE DATA | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE | | | |
| Distal fatigue, neck fatigue, range of motion, biocompatibility | | | |
| 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 | | | |
4
5
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The subject DePuy Actis DuoFix hip stems are substantially equivalent to the predicates Summit DuoFix and DePuy Corail AMT hip prostheses.