(42 days)
The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.
The Pinnacle Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®) hemispherical outer acetabular shell manufactured from titanium alloy (Ti-6Al-4V) with a thin layer of hydroxyapatite (HA) coating applied. The interior of the acetabular cup is designed with a groove and a taper for use with either an ultra-high molecular weight polyethylene (UHMWPE) or metal acetabular cup liner, which lock into the shell. Articulation occurs between the liner, and a femoral head with the appropriately sized diameter. The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to occlude the apical hole in order to prevent particulate migration and provide polyethylene support. The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole” (Sector series) configurations.
This document is a 510(k) Premarket Notification for the DePuy Pinnacle Duofix™ HA Acetabular Cup Prosthesis. It aims to demonstrate substantial equivalence to previously cleared devices (K000306 and K031495) rather than proving a specific medical device meets acceptance criteria through clinical studies.
Therefore, the information requested in your prompt for a study proving a device meets acceptance criteria, including specifics about an AI/human reader study, ground truth establishment, and sample sizes for training/test sets, is not present in this document.
This submission is focused on:
- Demonstrating equivalence: The primary purpose is to show that the modified device (manufacturing location, sterilization sites, and packaging change) is as safe and effective as previously cleared predicate devices.
- Non-clinical testing: The performance data listed are non-clinical (biological safety, sterilization validation, HA coating characterization).
- No clinical tests: The document explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence."
In summary, there is no study described in this document that proves the device meets explicit acceptance criteria through the types of clinical or AI performance studies your prompt asks about.
If you have a document discussing an AI/medical device performance study, please provide that, and I can attempt to extract the relevant information.
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November 26, 2019
DePuy Orthopaedics, Inc. % Margaret Shaughnessy Regulatory Affairs Project Leader DePuy (Ireland) Loughbeg, Ringakiddy CORK P43D82 IRELAND
Re: K192919
Trade/Device Name: Pinnacle Duofix HA Acetabular Cup 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 Dated: October 11, 2019 Received: October 15, 2019
Dear Margaret Shaughnessy:
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 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.
for
Vesa Vuniqi Acting Assistant 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)
K192919
Device Name DePuy Pinnacle Duofix™ HA Acetabular Cups
Indications for Use (Describe)
The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics |
| Address | 700 Orthopedic DriveWarsaw, IN 46582 |
| Phone number | 574 372 7020 |
| Fax number | 574- 371-4987 |
| Establishment Registration Number | 1818910 |
| Name of contact person | Kathy Harris |
| Date prepared | |
| Name of device | |
| Trade or proprietary name | Pinnacle Duofix™ HA Acetabular Cup Prosthesis |
| Common or usual name | Acetabular Cup Prosthesis |
| Classification name | Hip joint metal/polymer/metal semi-constrained porous coated uncementedprosthesis |
| Class | II |
| Classification panel | 87 Orthopedic and Rehabilitation Devices |
| Regulation | 888.3358 |
| Product Code(s) | LPH |
| Legally marketed device(s) towhich equivalence is claimed | Pinnacle Duofix™ HA Acetabular Cup Prosthesis – K000306, K031495 |
| Reason for 510(k) submission | The purpose of this submission is to support the manufacturing of the subjectPinnacle Duofix™ HA Acetabular Cup Prosthesis System components at anadditional manufacturing facility for all process steps at DePuy Ireland. Thisincludes the HA coating process step within the DePuy Ireland manufacturingsite. There is also the addition of two alternative sterilization sites being addedfor Business Continuity Purposes. There is a modification to the packagingprocess too. We are converting from a double pouch packaging system to adouble blister packaging system as per the original submission K000306There are no other modifications associated with this product in comparisonwith the currently marketed Pinnacle Duofix™ HA Acetabular Cup Prosthesis- the predicate and proposed device share the same intended use, productdesign, principle of operation, and materials. |
| Device description | The Pinnacle Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®) hemispherical outer acetabular shell manufactured fromtitanium alloy (Ti-6Al-4V) with a thin layer of hydroxyapatite (HA) coatingapplied.The interior of the acetabular cup is designed with a groove and a taper for usewith either an ultra-high molecular weight polyethylene (UHMWPE) or metal |
| acetabular cup liner, which lock into the shell. Articulation occurs between the liner, and a femoral head with the appropriately sized diameter. The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to occlude the apical hole in order to prevent particulate migration and provide polyethylene support. The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole” (Sector series) configurations. | |
| Intended use of the device | The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application. |
| Indications for use | The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application |
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| Characteristics | Subject Device:Pinnacle Duofix™ HA AcetabularCup Prosthesis | Predicate Device:Pinnacle Duofix™HA Acetabular CupProsthesis – K031495 | Predicate Device:Pinnacle Duofix™ HAAcetabular Cup Prosthesis– K000306 |
|---|---|---|---|
| Intended Use | The Pinnacle Duofix™ HAAcetabular Cup Prosthesis isindicated for use in total hipreplacement procedures forpatients suffering severe pain anddisability due to structural damagein the hip joint from rheumatoidarthritis, osteoarthritis, post-traumatic arthritis, collagendisorders, avascular necrosis, andnonunion of femoral fractures.Use of the prosthesis is alsoindicated for revision of theprevious hip arthroplasty and forpatients with congenital hipdysplasia, protrusio acetabuli,slipped capital femoral epiphysisand disability due to previousfusion, where bone stock isinadequate for other reconstructiontechniques. | Same | Same |
| Material | Acetabular Shell: ForgedTitanium alloy (Ti-6Al-4V)conforms to ASTM F-620Porous Coating: Commerciallypure unalloyed (ASTM F67)titanium sintered bead porouscoating (Porocoat®)HA Coating: the HA powderused in a plasma spray process,conforms to ASTM F1185Hydroxyapatite ( $Ca_5(PO_4)_3OH$ )ceramic. | Same | Acetabular Shell:Wrought titanium alloy (Ti-6Al-4V) conforms toASTM F-136 or forgedtitanium alloy (Ti-6Al-4V)conforms to ASTM F-620Porous Coating:Commercially pureunalloyed (ASTM F67)titanium sintered beadporous coating(Porocoat®) |
| Fixation | Cementless | Same | Same |
| Cup Size | Pinnacle Cup 100 Series48, 50, 52, 54, 56, 58, 60, 62, 64,66Pinnacle Cup Sector Series48, 50, 52, 54, 56, 58, 60, 62, 64,66 | Same | Same |
| Characteristics | Subject Device:Pinnacle Duofix™ HA AcetabularCup Prosthesis | Predicate Device:Pinnacle Duofix™ HA Acetabular CupProsthesis - K031495 | Predicate Device:Pinnacle Duofix™ HAAcetabular Cup Prosthesis- K000306 |
| Sterile Method | Sterilization method and dose:Cobalt-60-Gamma radiation (25-40kGy) | Same | Same |
| Packaging | Double blister packagingconsisting of inner and outer traysof Polyethylene TerephthalateGlycol copolymer (PETG) withlids of TYVEK®. | Double peel pouchpackaging consistingof an inner and anouter vacuum sealedpouch of Nylonpolymer | Same |
| Shelf Life | 10 Year | Same | Same |
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PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The following tests were performed on the Pinnacle Cup 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".
- . Sterilization validation per AAMI ANSI ISO 11137-1: 2006/(R)2010 and AAMI ANSI ISO 11137-2: 2013
- Characterization testing of Hydroxyapatite Coating as recommended per FDA Guidance: ● "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implant"
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 Pinnacle Cup products are substantially equivalent to the predicate Pinnacle Cup products (K00306, K031495)
§ 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.