(83 days)
No
The summary describes a mechanical hip prosthesis and does not mention any AI or ML components or functions.
Yes.
The device is a femoral stem used in hip replacement surgeries, which aims to alleviate pain and disability, thereby providing therapeutic benefit to patients with severely damaged hip joints.
No
This device is a hip prosthesis, an implant used in hip replacement surgery to treat conditions like osteoarthritis and fractures. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a forged titanium femoral stem, which 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 implant for replacing or partially replacing a hip joint due to various conditions affecting the bone and joint structure. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a forged titanium femoral stem, a physical implant designed to be surgically placed within the body. This is consistent with a medical device for surgical use, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the DePuy Actis DuoFix Hip Prosthesis – Collarless is a surgical implant, 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.
Hemi-hip arthroplasty is indicated in the following conditions:
-
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated 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 - Collarless 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 Prosthesis – Collarless is a forged titanium (Ti-6Al-4V) femoral stem designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with both unipolar and bipolar femoral heads intended for hemi-hip arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.
The Actis DuoFix Hip Prosthesis – Collarless implants have sintered commercially pure titanium bead porous coating (Porocoat®) and a 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 Actis DuoFix Hip Prosthesis – Collarless is designed as a line extension to the primary predicate Actis DuoFix Hip Prosthesis (K160907) to meet the need of surgeons whose preference is to use a femoral stem without a collar for 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)
Medical Device Performance Data:
Distal fatigue testing (to ISO 7206-4: 2010), neck fairge testing (to ISO 7206-6:2013) and biocompatibility evaluation (to ISO 1099-1:2018, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2017 and ISO 10993-18:2020) were carried out as part of design verification for the devices in order to demonstrate substantial equivalence of safety and efficacy with the predicate devices.
Magnetic Resonance Imaging safety evaluation testing was performed using ASTM F2503-13, and the tests evaluated the worst-case components and constructs for magnetically induced force (ASTM F2213-17), image artefact (ASTM 2119-07) and RF heating (ASTM F2182-11a). The testing concluded that there are no safety issues related to magnetic field interactions identified in the labelling.
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
Hydroxyaatie characterization data, as recommended in the FDA Guidance 510(k) Information needed for Hydrosy, while hands, is provided.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2021
DePuy Ireland UC % Erin Combs Senior Regulatory Affairs Specialist Depuy Orthopaedics, Inc 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K210581
Trade/Device Name: Actis DuoFix Hip Prosthesis- Collarless 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: April 30, 2021 Received: May 3, 2021
Dear Erin Combs:
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 mediation-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,
William Jung, Ph.D. Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210581
Device Name Actis DuoFix Hip Prosthesis - Collarless
Indications for Use (Describe)
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.
Hemi-hip arthroplasty is indicated in the following conditions:
-
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated 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 - Collarless is indicated for cementless use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
.
3
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4
510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, Ringaskiddy |
| Co. Cork, IRELAND | |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Elaine Pears |
| e-mail address | epears@its.jnj.com and DePuySynthesJointsRegulatoryAffairs@its.jnj.com |
| Alternative contact person | Clare Hill |
| e-mail address | chill7@its.jnj.com |
| Work mobile | +44 7795 389956 (UK time zone) |
| Date prepared | 16th February 2021 |
| Name of device | |
| Trade or proprietary name | DePuy Actis DuoFix Hip Prosthesis – Collarless |
| 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) | MEH, LPH, KWL, KWY |
| Legally marketed device(s) to | |
| which equivalence is claimed | Primary predicate - DePuy Actis DuoFix Hip Prosthesis K160907, cleared July |
| 19, 2016 | |
| Secondary predicate - DePuy Summit DuoFix Hip Prosthesis K170339, | |
| cleared April 26, 2018 | |
| Reference predicate for hydroxyapatite (HA) coating process step – DePuy | |
| Actis DuoFix Hip Prosthesis K202472, cleared October 21, 2020 | |
| Reason for 510(k) submission | The purpose of this 510K submission is to obtain market clearance for DePuy |
| Actis DuoFix Hip Prosthesis - Collarless. | |
| Device description | The DePuy Actis DuoFix Hip Prosthesis – Collarless is a forged titanium (Ti-6Al-4V) femoral stem designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with both unipolar and bipolar femoral heads intended for hemi-hip arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty |
| The Actis DuoFix Hip Prosthesis – Collarless implants have sintered commercially pure titanium bead porous coating (Porocoat®) and a 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 Actis DuoFix Hip Prosthesis – Collarless is designed as a line extension to the primary predicate Actis DuoFix Hip Prosthesis (K160907) to meet the need of surgeons whose preference is to use a femoral stem without a collar for hip arthroplasty. | |
| Intended use of the device | Total hip arthroplasty and hemi-hip arthroplasty |
| Indications for use | 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.
- Certain cases of ankylosis.
Hemi-hip 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 hemi-hip arthroplasty. |
5
6
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES | ||||
|---|---|---|---|---|
| Characteristics | Subject Device: | |||
| DePuy Actis DuoFix | ||||
| Hip Prosthesis - | ||||
| Collarless | Primary Predicate Device: | |||
| DePuy Actis DuoFix Hip Prosthesis | ||||
| K160907 | Secondary Predicate Device: | |||
| DePuy Summit DuoFix Hip Prosthesis K170339 | ||||
| Intended Use | ||||
| and Indications | ||||
| for Use | Same as primary | |||
| predicate | Intended for use in total hip arthroplasty and hemi-hip | |||
| arthroplasty. | ||||
| 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.
- Certain cases of ankylosis.
Hemi-hip 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 hemi-hip arthroplasty. | Intended for use in total hip arthroplasty and hemi-hip
arthroplasty.
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,
fixation,
arthrodesis.
internal
hemiarthroplasty, surface replacement arthroplasty, or
total hip replacement. - 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. | |
| | | | | |
| Material | Same as primary
predicate | Femoral stem: Wrought titanium alloy
Porous coating: Commercially pure unalloyed
Titanium sintered bead porous coating (Porocoat®)
HA coating: Hydroxyapatite powder | Same as primary predicate | |
| Fixation | Same as primary
predicate | Uncemented | Same as primary predicate | |
| Stem Size | Same as primary
predicate | 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 | |
| Neck Offset | Same as primary
predicate | Standard, High | Same as primary predicate | |
| Collar | Same as secondary
predicate | Collared | Collarless | |
| Sterile Method | Same as primary
predicate | Gamma irradiation | Same as primary predicate | |
| SAL | Same as primary
predicate | 10⁻⁶ | Same as primary predicate | |
| Packaging | Same as primary
predicate | Double PETG blister with Tyvek peel lid | Same as primary predicate | |
| Shelf Life | Same as primary
predicate | 10 years | Same as primary predicate | |
7
8
The subject device [Acts DuoFix Hip Prosthess] is identical in design to the primary predicate device [Actis DuoFix Hip Prosthesis (K160907) with the single exception that, in common with the secondary predicate [Summit DuoFix Hip Prosthesis (K170339)], there is no collar on the neck of the device.
The subject device has the same intentialy and secondary predicate devices. The subject and both predicate devices are made from the same materials and have the same method of fixation. Sterility Assurance Level (SAL), packaging materials and shelf-life are the same across the subject and predicate devices.
Indications for use and range of stem sizes and neck offsets available are identical for the subject device and the primary predicate.
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Distal fatigue testing (to ISO 7206-4: 2010), neck fairge testing (to ISO 7206-6:2013) and biocompatibility evaluation (to ISO 1099-1:2018, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2017 and ISO 10993-18:2020) were carried out as part of design verification for the devices in order to demonstrate substantial equivalence of safety and efficacy with the predicate devices.
Magnetic Resonance Imaging safety evaluation testing was performed using ASTM F2503-13, and the tests evaluated the worst-case components and constructs for magnetically induced force (ASTM F2213-17), image artefact (ASTM 2119-07) and RF heating (ASTM F2182-11a). The testing concluded that there are no safety issues related to magnetic field interactions identified in the labelling.
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
Hydroxyaatie characterization data, as recommended in the FDA Guidance 510(k) Information needed for Hydrosy, while hands, is provided.
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
The subject DePuy Actis DuoFix Hip Prosthess devices are substantially equivalent to the predicate DePuy Actis DuoFix and DePuy Summit DuoFix hip prostheses (K160907 and K170339).