(54 days)
No
The summary describes a mechanical hip prosthesis and its materials. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a hip prosthesis, which is designed to replace a damaged hip joint and restore its function, thereby treating conditions like severe pain, disability, and fractures.
No
The provided text describes a hip prosthesis, which is an implant used for hip replacement surgery. Its intended use is to replace damaged hip joints, not to diagnose medical conditions.
No
The device description clearly states it is a hip prosthesis manufactured from forged titanium alloy with various coatings, 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/Indications for Use: The intended use describes the device as a hip prosthesis for surgical implantation to treat various conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials, manufacturing process, and physical characteristics of a hip implant. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Performance Studies: The performance studies listed are non-clinical tests related to the physical and biological safety of the implant (fatigue testing, biological evaluation, coating characterization). These are typical tests for implantable medical devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
In summary, the device is a surgical implant designed to replace or partially replace a damaged hip joint. This falls under the category of a therapeutic medical device, 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, 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 hemiarthroplasty.
The ACTISTM DUOFIX™ Hip Prosthesis is indicated for cementless use only.
Product codes
LPH, MEH, KWL, KWY
Device Description
The ACTIS Duofix™ Hip Prosthesis is identical to the previously cleared ACTIS Duofix™ Hip Prosthesis (K150862 & K160907). The ACTIS Duofix™ Hip prostheses are manufactured from forged titanium alloy (Ti6Al4V), 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 anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-athroplasty and with modular metal or ceramic femoral heads intended for total hip arthroplasty.
The porous coating is applied over the proximal region of the stem. A thin coating of hydroxyapatite (HA) of uniform thickness is sprayed over the porous and distal stem areas via a plasma spray process. The HA powder used in the plasma spray process conforms to ASTM F1185-88 and ISO 13779-6 Hydroxyapatite (Ca5(PO4)3OH) ceramic. The plasma spray process used to apply the HA coating to the ACTIS Duofix™ Stem is the same process used to coat the SUMMIT Duofix™ Stem which was cleared in K193398. The HA material used for the ACTIS Duofix™ Stem is the same as the HA material used on the SUMMIT Duofix™ Stem. Thirteen sizes of prostheses are provided to allow high resolution of fit within host femora. Each size is offered in standard and high offset neck options, desired recreation of patient biomechanics in combination with head and liner combinations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, femoral neck, proximal femur, acetabulum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
The following tests were performed on the ACTIS Hip to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- Biological safety per ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
- Characterization testing of Hydroxyapatite Coating as recommended per FDA Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"
- Performance Bench Testing - Body (Distal) Fatigue Testing per ISO 7206-4 2010.
No clinical tests were necessary to clear the current device and thus no clinical testing was conducted here to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
October 21, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo, which includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in bold, blue letters, and 'ADMINISTRATION' in smaller, blue letters below.
DePuy Orthopaedics Inc. % Ann Geraghty Regulatory Affairs Acting Project Leader DePuy Ireland Loughbeg Ringaskiddy Cork, Co. Cork P43ED82 Ireland
Re: K202472
Trade/Device Name: ACTIS Duofix Hip Prosthesis Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, MEH, KWL, KWY Dated: September 17, 2020 Received: September 22, 2020
Dear Ann Geraghty:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vesa Vuniqi, M.S. Assistant Director DHTA: Division of Joints Arthroplasty OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K202472
Device Name ACTIS Duofix Hip Prosthesis
Indications for Use (Describe)
Total hip replacement or hip arthroplasty is indicated in the following conditions:
-
A severely painful and/or disabled joint from osteoarthritis, 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 hemiarthroplasty.
The ACTISTM DUOFIX™ Hip Prosthesis is indicated for cementless use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary 6.
6.1.
| Submitter Information | |
|---|---|
| Name | DePuy Ireland |
| Address | Loughbeg, Ringaskiddy, Co. Cork, Ireland |
| Phone number | +353-21-4914857 |
| Fax number | 574- 371-4987 |
| Establishment Registration | |
| Number | 1818910 |
| Name of contact person | Ann Geraghty |
| Date prepared | 21st October 2020 |
| Name of device | |
| Trade or proprietary | |
| name | ACTIS Duofix™ Hip Prosthesis |
| Common or usual name | Uncemented Hip Prosthesis |
| Classification name | MEH - Hip joint metal/ceramic/polymer semi-constrained cemented or |
| non-porous 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 Orthopedic |
| 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 | Primary Predicate: |
| DePuy ACTIS Duofix™ Hip Prosthesis | |
| K150862 (sizes 1-12) cleared September 25, 2015 |
Additional Predicates:
DePuy ACTIS Duofix™ Hip Prosthesis
K160907 (size 0) cleared July 19th, 2016
DePuy SUMMIT Duofix™ Hip Prosthesis
K193398, cleared February 4, 2020 |
| Reason for 510(k)
submission | The purpose of this submission is to support the change to add DePuy
Ireland as an alternate manufacturing facility for the HA coating
process step and to add DePuy Orthopaedics Inc. Warsaw IN as an |
| | |
| | alternate site for grit-blasting the device prior to coating.
The remaining manufacturing process steps will continue to be
performed at the existing locations. |
| | There are no other modifications to the product associated with these
changes in comparison with the currently marketed ACTIS Hip
System – the predicate and proposed device share the same intended
use, product design, principle of operation, and materials. |
| Device description | The ACTIS Duofix™ Hip Prosthesis is identical to the previously
cleared ACTIS Duofix™ Hip Prosthesis (K150862 & K160907). The
ACTIS Duofix™ Hip prostheses are manufactured from forged
titanium alloy (Ti6Al4V), 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 anatomical match
for each patient. The stems are compatible with both unipolar and
bipolar heads intended for hip hemi-athroplasty and with modular
metal or ceramic femoral heads intended for total hip arthroplasty. |
| | The porous coating is applied over the proximal region of the stem.
A thin coating of hydroxyapatite (HA) of uniform thickness is
sprayed over the porous and distal stem areas via a plasma spray
process. The HA powder used in the plasma spray process
conforms to ASTM F1185-88 and ISO 13779-6 Hydroxyapatite
(Ca5(PO4)3OH) ceramic. The plasma spray process used to apply the
HA coating to the ACTIS Duofix™ Stem is the same process used
to coat the SUMMIT Duofix™ Stem which was cleared in
K193398. The HA material used for the ACTIS Duofix™ Stem is
the same as the HA material used on the SUMMIT Duofix™ Stem.
Thirteen sizes of prostheses are provided to allow high resolution of
fit within host femora. Each size is offered in standard and high
offset neck options, desired recreation of patient
biomechanics in combination with head and liner combinations. |
| Intended use of the device | The ACTIS Duofix™ Hip Prosthesis is intended for use in total hip
arthroplasty 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.
The ACTIS Duofix™ Hip Prosthesis is intended for use in hemi-hip
arthroplasty where there is evidence of a satisfactory natural
acetabulum and sufficient femoral bone to seat and support the
femoral stem. |
| 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.
Hemi hip replacement 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 hemi-hip arthroplasty.
The ACTIS Duofix™ Hip Prosthesis is indicated for cementless use only. |
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5
6
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed on the ACTIS Hip to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- Biological safety per ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
- . Characterization testing of Hydroxyapatite Coating as recommended per FDA Guidance: "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"
- । Performance Bench Testing - Body (Distal) Fatigue Testing per ISO 7206-4 2010.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were necessary to clear the current device and thus no clinical testing was conducted here to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy ACTIS Duofix™ Hip products are substantially equivalent to the predicate ACTIS and Summit Hip products (K150862, K160907 and K193398)