Who is the manufacturer of ACTIS Duofix Hip Prosthesis?

DePuy Orthopaedics, Inc. filed the 510(k) submission for ACTIS Duofix Hip Prosthesis (K202472).

What is the FDA product code for ACTIS Duofix Hip Prosthesis?

LPH. It is classified under 21 CFR 888.3358 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ACTIS Duofix Hip Prosthesis?

510(k) clearance (submission type: Special).

What are the predicate devices for ACTIS Duofix Hip Prosthesis?

DePuy ACTIS Duofix Hip Prosthesis (K150862); DePuy ACTIS Duofix Hip Prosthesis (K160907); DePuy SUMMIT Duofix Hip Prosthesis (K193398).

Who can help prepare an FDA 510(k) submission like ACTIS Duofix Hip Prosthesis?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ACTIS Duofix Hip Prosthesis

K202472 · DePuy Orthopaedics, Inc. · LPH · Oct 21, 2020 · Orthopedic

Device Facts

Record ID	K202472
Device Name	ACTIS Duofix Hip Prosthesis
Applicant	DePuy Orthopaedics, Inc.
Product Code	LPH · Orthopedic
Decision Date	Oct 21, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

ACTIS Duofix Hip Prosthesis; femoral stem component for total or hemi-hip arthroplasty. Device replaces damaged hip joint articulation; provides increased mobility; reduces pain. Forged titanium alloy (Ti6Al4V) stem; porous-coated with sintered commercially pure titanium beads (Porocoat); thin plasma-sprayed hydroxyapatite (HA) coating. Thirteen sizes; standard and high offset neck options; compatible with unipolar/bipolar heads or modular femoral heads. Used in orthopedic surgery; implanted by surgeons. Device provides anatomical match; supports patient biomechanics; relies on host bone for seating/support. Submission adds alternate manufacturing facilities for HA coating and grit-blasting processes.

Clinical Evidence

No clinical data; bench testing only. Performance demonstrated via biological safety evaluation (ISO 10993-1), hydroxyapatite coating characterization per FDA guidance, and distal fatigue testing (ISO 7206-4).

Technological Characteristics

Materials: Forged titanium alloy (Ti6Al4V), sintered commercially pure titanium bead porous coating (Porocoat), and plasma-sprayed hydroxyapatite (HA) coating conforming to ASTM F1185-88 and ISO 13779-6. Design: Modular femoral stem with 13 sizes, standard/high offset options. Cementless fixation. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total hip arthroplasty or hemi-hip arthroplasty due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture of the femoral head/neck, ankylosis, fracture dislocation, non-union of femoral neck fractures, or degenerative arthritis. Indicated for cementless use only.

Regulatory Classification

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.

Predicate Devices

DePuy ACTIS Duofix Hip Prosthesis (K150862)
DePuy ACTIS Duofix Hip Prosthesis (K160907)
DePuy SUMMIT Duofix Hip Prosthesis (K193398)

Related Devices

K150862 — DePuy Actis Duofox Hip Prosthesis · DePuy Orthopaedics, Inc. · Sep 25, 2015
K210581 — Actis DuoFix Hip Prosthesis- Collarless · Depuy Ireland UC · May 20, 2021
K160907 — DePuy Actis DuoFix Hip Prosthesis · Depuy(Ireland) · Jul 19, 2016
K001991 — TITAN POROCOAT HIP PROSTHESIS · DePuy Orthopaedics, Inc. · Aug 25, 2000
K192946 — DePuy Corail AMT Hip Prosthesis · DePuy Orthopaedics, Inc. · Nov 26, 2019

Submission Summary (Full Text)

{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: 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. 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 hemiarthroplasty. The ACTISTM DUOFIX™ Hip Prosthesis is indicated for cementless use only. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "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: 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 replacement 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. The ACTIS Duofix™ Hip Prosthesis is indicated for cementless use only. | {4}------------------------------------------------ {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)