Actis DuoFix Hip Prosthesis- Collarless

• K Number: K210581
• Device Name: Actis DuoFix Hip Prosthesis- Collarless
• Manufacturer: DePuy Ireland UC
• Date Cleared: 2021-05-20 ( 83 days)
• Product Code: MEH , KWL , KWY , LPH
• Regulation Number: 888.3353
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K202472 , K160907 , K170339
• Predicate For: K211657 , K221104 , K231873 , K251166

Intended Use

Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, 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.

Hemi-hip arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated 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 hemi-hip arthroplasty.

The ACTIS™ DUOFIX™ Hip Prosthesis - Collarless is indicated for cementless use only.

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.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, especially in the context of an AI/ML-based medical device.

The document is a 510(k) premarket notification for a hip prosthesis (Actis DuoFix Hip Prosthesis - Collarless). It focuses on demonstrating substantial equivalence to predicate hip prostheses based on material, design, intended use, indications for use, and non-clinical testing (fatigue testing, biocompatibility, MRI safety, bacterial endotoxin testing, HA characterization).

Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, or how ground truth was established for a machine learning model, as this information is not present in the provided text.

Summary

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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.

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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 ([e-mail]) or phone [phone] 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

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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:

1. A severely painful and/or disabled joint from osteoarthritis, 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.

Hemi-hip arthroplasty is indicated in the following conditions:

• 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated 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 hemi-hip arthroplasty.

The ACTIS™ DUOFIX™ Hip Prosthesis - Collarless is indicated for cementless use only.

Type of Use (Select one or both, as applicable)
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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.

.

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510(K) SUMMARY

(As required by 21 CFR 807.92 and 21 CFR 807.93)

Submitter Information
Name	DePuy Ireland UC
Address	Loughbeg, RingaskiddyCo. Cork, IRELAND
Establishment RegistrationNumber	3015516266
Name of contact person	Elaine Pears
e-mail address	[e-mail] and [e-mail]
Alternative contact person	Clare Hill
e-mail address	[e-mail]
Work mobile	[phone] (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 uncementedprosthesis;Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis;Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis;Hip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis.
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) towhich equivalence is claimed	Primary predicate - DePuy Actis DuoFix Hip Prosthesis K160907, cleared July19, 2016Secondary predicate - DePuy Summit DuoFix Hip Prosthesis K170339,cleared April 26, 2018Reference predicate for hydroxyapatite (HA) coating process step – DePuyActis 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 DePuyActis 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 arthroplastyThe 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: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.Hemi-hip 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 hemi-hip arthroplasty.

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES
Characteristics	Subject Device:DePuy Actis DuoFixHip Prosthesis -Collarless	Primary Predicate Device:DePuy Actis DuoFix Hip ProsthesisK160907	Secondary Predicate Device:DePuy Summit DuoFix Hip Prosthesis K170339
Intended Useand Indicationsfor Use	Same as primarypredicate	Intended for use in total hip arthroplasty and hemi-hiparthroplasty.Total hip replacement is indicated in the followingconditions:1. A severely painful and/or disabled joint fromosteoarthritis, 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.Hemi-hip arthroplasty is indicated in the followingconditions:1. Acute fracture of the femoral head or neck that cannotbe appropriately reduced and treated with internalfixation.2. Fracture dislocation of the hip that cannot beappropriately reduced and treated with internalfixation.3. Avascular necrosis of the femoral head.4. Non-union of femoral neck fractures.5. Certain high subcapital and femoral neck fractures inthe elderly.6. Degenerative arthritis involving only the femoral headin whichthe acetabulum does not requirereplacement.7. Pathology involving only the femoral head/neckand/or proximal femur that can be adequatelytreated by hemi-hip arthroplasty.	Intended for use in total hip arthroplasty and hemi-hiparthroplasty.Total hip replacement is indicated in the followingconditions:1. A severely painful and/or disabled joint fromosteoarthritis, traumatic arthritis, rheumatoid arthritis, orcongenital hip dysplasia.2. Avascular necrosis of the femoral head.3. Acute traumatic fracture of the femoral head or neck.4. Failed previous hipsurgery including jointreconstruction,fixation,arthrodesis.internalhemiarthroplasty, surface replacement arthroplasty, ortotal hip replacement.5. Certain cases of ankylosis.Hemi-hip replacement is indicated in the followingconditions:1. Acute fracture of the femoral head or neck that cannotbe appropriately reduced and treated with internalfixation.2. Fracture dislocation of the hip that cannot beappropriately 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 inthe elderly.6. Degenerative arthritis involving only the femoral headin which the acetabulum does not require replacement.7. Pathology involving only the femoral head/neck and/orproximal femur that can be adequately treated by hemi-hip arthroplasty.
Material	Same as primarypredicate	Femoral stem: Wrought titanium alloyPorous coating: Commercially pure unalloyedTitanium sintered bead porous coating (Porocoat®)HA coating: Hydroxyapatite powder	Same as primary predicate
Fixation	Same as primarypredicate	Uncemented	Same as primary predicate
Stem Size	Same as primarypredicate	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 primarypredicate	Standard, High	Same as primary predicate
Collar	Same as secondarypredicate	Collared	Collarless
Sterile Method	Same as primarypredicate	Gamma irradiation	Same as primary predicate
SAL	Same as primarypredicate	10⁻⁶	Same as primary predicate
Packaging	Same as primarypredicate	Double PETG blister with Tyvek peel lid	Same as primary predicate
Shelf Life	Same as primarypredicate	10 years	Same as primary predicate

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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).

Regulation Number and Section

§ 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.