(29 days)
The PINNACLETM Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history or prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options of constrained acetabular components have been considered.
The PINNACLETM Constrained Acetabular Liner is indicated for use with the PINNACLETM Acetabular Cup in cementless application.
The PINNACLE™ Constrained Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra-high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-Al6-V4). The liner component articulates with a metal femoral head of an appropriate diameter.
The PINNACLE™ Constrained Acetabular Liner mechanically constrains the femoral head within the inner diameters of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.
The PINNACLE™ Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters compatible with standard metal femoral heads sized 28, 32, and 36mm, as well as larger diameter unipolar, Self-Centering (bipolar) and Modular M femoral heads sized 40 and 44mm. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Liners, in a 48mm-76mm size range offering.
This document is a 510(k) premarket notification for the PINNACLETM Constrained Acetabular Liners. The submission is not for a new device but for an expansion of the labeling to include updated MRI compatibility information, standardization of language and symbols, and inclusion of new internationally recognized symbols and implant cards for international markets. Crucially, the document states: "There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices."
Therefore, the acceptance criteria and study information typically associated with a new or significantly modified device, especially regarding clinical performance or algorithm evaluation, are not provided in this regulatory document. The focus of this submission is on demonstrating the device's acceptable performance in an MRI environment.
Here's an analysis based on the provided text, but it will be limited due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
The document focuses on MRI safety evaluation. The acceptance criteria are implicit in the adherence to established ASTM standards for MRI compatibility. The reported performance indicates that the device met these standards.
| Acceptance Criteria (Implicit from ASTM Standards) | Reported Device Performance (Summary) |
|---|---|
| Acceptable Magnetically Induced Displacement Force | Met (tested per ASTM F2052-21) |
| Acceptable Magnetically Induced Displacement Torque | Met (tested per ASTM F2213-17) |
| Acceptable Radio Frequency (RF) Heating | Met (tested per ASTM F2182-19) |
| Acceptable Image Artifacts | Met (tested per ASTM F2119-07) |
| No new questions of safety or efficacy in MR environment | Established by non-clinical performance data and review of K231873 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Non-clinical testing" and "full test data present and reviewed in the FDA cleared submission 'K231873 - DePuy Hip Portfolio MRI Bundled Traditional 510(k)'". This indicates that the testing was non-clinical (ex-vivo/in-vitro), not involving human subjects. The sample size would refer to the number of devices or components tested, but this specific detail (the exact number of liners tested) is not provided in this document. The provenance is not explicitly stated beyond "DePuy Ireland UC" as the submitter, implying the testing was conducted or overseen by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the study involved non-clinical MRI safety testing of a physical device, not an AI or diagnostic device requiring human expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for non-clinical testing of device properties like MRI compatibility.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This submission is for a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the objective measurement of physical properties of the device under MRI conditions, compared against the limits established by the referenced ASTM standards.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
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April 4, 2024
Depuy Ireland UC Jennifer Hill Regulatory Affairs Project Leader Loughbeg, Ringaskiddy County Cork, Ireland
Re: K240639
Trade/Device Name: PINNACLE 114 Constrained Acetabular Liners Regulation Number: 21 CFR 888.3310 Regulation Name: Hip Joint Metal/Polymer Constrained Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWZ Dated: March 6, 2024 Received: March 6, 2024
Dear Jennifer Hill:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Limin Sun - S
Limin Sun, Ph.D. 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
Submission Number (if known)
Device Name
PINNACLETM Constrained Acetabular Liner
Indications for Use (Describe)
The PINNACLETM Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history or prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options of constrained acetabular components have been considered.
The PINNACLETM Constrained Acetabular Liner is indicated for use with the PINNACLETM Acetabular Cup in cementless application.
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)
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| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | LoughbegRingaskiddyCo. CorkIreland |
| Phone number | (+44) 7834974433 |
| Fax number | N/A |
| Establishment Registration Number | 3015516266 |
| Name of contact person | Jennifer Hill |
| Date prepared | 06th March 2024 |
| Name of device | |
| Trade or proprietary name | PINNACLETM Constrained Acetabular Liners |
| Common or usual name | Acetabular Cup Prosthesis |
| Classification name | 21 CFR 888.3310: Hip joint metal/polymer constrained cemented or uncemented prosthesis. |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | Class II – 21 CFR 888.3310 |
| Product Code(s) | KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Legally marketed device(s) to whichequivalence is claimed | K043058/K052079/K071117 - PINNACLE™ Constrained Acetabular Liners |
| Reason for 510(k) submission | DePuy Ireland UC has compiled a Special 510(k) Premarket Notification to expand the labeling forthe DePuy PINNACLE™ Constrained Acetabular Liners, to provide updated information regardingthe MRI compatibility of the devices. A program of MRI Safety Evaluation testing has been carriedout with full test data present and reviewed in the FDA cleared submission 'K231873 - DePuy HipPortfolio MRI Bundled Traditional 510(k)'. Appropriate amends have been made to the productlabels and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients. |
| At the same time as making these labeling updates in relation to MRI compatibility, DePuy will takethe opportunity to standardize language and symbols used across its legacy devices for consistency,including the use of new internationally recognized symbols with corresponding updated symbolsglossaries. | |
| Additionally, in order to harmonize with International and EU labeling requirements, the labelingof subject devices which are sold Internationally will be further updated to also include a newImplant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and canbe discarded by the end user. The labeling will also be updated to include a material code withcorresponding material descriptions. | |
| There is no change to the indications, intended use, safety, fit, form or technological characteristicsof the devices. | |
| Device description | The PINNACLE™ Constrained Acetabular Liner is part of a modular system designed to replace thenatural articular surface of the hip joint in total hip replacement. The liner is manufactured fromultra-high molecular weight polyethylene (UHMWPE), which locks into a porous coated,hemispherical outer shell component manufactured from titanium alloy (Ti-Al6-V4). The linercomponent articulates with a metal femoral head of an appropriate diameter. |
| The PINNACLE™ Constrained Acetabular Liner mechanically constrains the femoral head withinthe inner diameters of the liner by providing greater than 180 degrees femoral head capturecombined with a titanium constraining ring which fits over the opening diameter of the liner. TheUHMWPE liner is held in the metal shell by means of a titanium locking ring.The PINNACLE™ Constrained Acetabular Liners are UHMWPE acetabular cup liners that areavailable in a lateralized neutral or lateralized face-changing orientation. The liners have innerdiameters compatible with standard metal femoral heads sized 28, 32, and 36mm, as well aslarger diameter unipolar, Self-Centering (bipolar) and Modular M femoral heads sized 40 and44mm. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Liners,in a 48mm-76mm size range offering. | |
| Intended use of the device | Total hip arthroplasty is intended to replace the damaged hip joint articulation in patients at ahigh risk of hip dislocation, where there is evidence of sufficient sound bone to seat and supportthe components. |
| Indications for use | The PINNACLE™ Constrained Acetabular Liner is indicated for use as a component of a total hipprosthesis in primary or revision patients at high risk of hip dislocation due to a history of priordislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instabilityand for whom all other options to constrained acetabular components have been considered.The PINNACLE™ Constrained Acetabular Liner is indicated for use with the PINNACLE™Acetabular Cup in cementless application. |
| Substantial Equivalence | DePuy Ireland UC has compiled a Special 510(k) Premarket Notification to expand the labeling forthe DePuy PINNACLE™ Constrained Acetabular Liners, to provide updated information regardingthe MRI compatibility of the devices. A program of MRI Safety Evaluation testing has been carriedout with full test data present and reviewed in the FDA cleared submission 'K231873 - DePuy HipPortfolio MRI Bundled Traditional 510(k)'. Appropriate amends have been made to the productlabels and Instructions for Use (IFU), along with the provision of new MR Safety Cards for patients. |
| At the same time as making these labeling updates in relation to MRI compatibility, DePuy will take the opportunity to standardize language and symbols used across its legacy devices for consistency, including the use of new internationally recognized symbols with corresponding updated symbols glossaries. | |
| Additionally, in order to harmonize with International and EU labeling requirements, the labeling of subject devices which are sold Internationally will be further updated to also include a new Implant Card, Implant Card Guide, and Implant Card Label. These are not US requirements and can be discarded by the end user. The labeling will also be updated to include a material code with corresponding material descriptions. | |
| There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices. | |
| Non-clinical testing is provided to support the conditional safety of the PINNACLETM Constrained Acetabular Liners in the MR environment, including assessment of:Magnetically Induced Displacement Force (ASTM F2052-21) Magnetically Induced Displacement Torque (ASTM F2213-17) Radio Frequency (RF) Heating (ASTM F2182-19) Image Artifacts (ASTM F2119-07) | |
| The non-clinical performance data demonstrate that the Subject Devices, when exposed to the MR environment under specific MR conditions of use, raise no new questions of safety or efficacy. |
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§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”