(164 days)
No
The document describes a mechanical implant for hip replacement and does not mention any AI/ML components or functions.
Yes
The device is described as a component of a total hip replacement system, which is used to treat a severely painful and/or disabled joint. This directly addresses and alleviates a medical condition, fitting the definition of a therapeutic device.
No
This device is a total hip replacement component (a dual mobility metal liner) used for surgical implantation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implant made of cobalt-chrome-molybdenum alloy, intended for surgical implantation in the hip joint. It undergoes mechanical and wear testing, which are characteristic of hardware devices, 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 states that the device is for total hip replacement, addressing conditions like painful joints, failed previous surgery, and dislocation risks. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details a metal liner and acetabular cups designed for articulation within the hip joint. This is a physical component for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
- Performance Studies: The performance studies focus on mechanical properties, wear testing, range of motion, and compatibility – all relevant to a surgical implant, not an IVD.
In summary, the device described is a surgical implant used in total hip replacement, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease).
-
- Failed previous hip surgery.
-
- Dislocation risks.
PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.
Product codes
LPH, LZO, MEH
Device Description
The DePuy PINNACLE Dual Mobility Liner is manufactured from cobalt-chrome-molybdenum alloy. The Liner is assembled with a taper locking mechanism to PINNACLE Acetabular Shells. The inner surface of the Dual Mobility Metal Liner articulates with a BI-MENTUM polyethylene mobile bearing head. The Dual Mobility construct is compatible with DePuy metal or ceramic modular femoral heads, for use in total hip arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The following tests were performed on the PINNACLE Dual Mobility Metal Liner to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- Range of motion in accordance with ISO 21535:2007 / AMD 2016 .
- Verification of product compatibility ●
- Standard walking wear testing .
- Jump distance assessment .
- Mechanical testing in partial compliance with ASTM F1820 ●
- Taper performance testing ●
- The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSVAAMI ST72:2011 ●
No clinical tests were conducted to demonstrate substantial equivalence.
Key results: The subject PINNACLE Dual Mobility Metal Liners are substantially equivalent to the predicate Stryker Modular Dual Mobility Metal Liner.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker Modular Dual Mobility (MDM) Liner (K103233, cleared February 3, 2011)
Reference Device(s)
BI-MENTUM Dual Mobility System (K181744, cleared December 11, 2018)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
September 11, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
DePuy Ireland UC % Melissa Cook Regulatory Affairs Specialist III DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw. Indiana 46582
Re: K200854
Trade/Device Name: DePuy PINNACLE Dual Mobility Liner 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, LZO, MEH Dated: August 10, 2020 Received: August 12, 2020
Dear Melissa Cook:
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.
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
1
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 (OS) 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,
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) K200854
Device Name
DePuy PINNACLE Dual Mobility Liner
Indications for Use (Describe)
Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease).
-
- Failed previous hip surgery.
-
- Dislocation risks.
PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications.
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)
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510(K) SUMMARY
(As required by 21 CFR 807.92)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg |
| Ringaskiddy | |
| Co. Cork, Ireland | |
| Phone number | 574-453-7014 |
| Establishment Registration | |
| Number | 3015516266 |
| Name of contact person | Melissa Cook |
| Date prepared | March 27, 2020 |
| Name of device | |
| Trade or proprietary name | DePuy PINNACLE Dual Mobility Liner |
| Common or usual name | Total hip joint replacement 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 | |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3358, 888.3353 |
| Product Code(s) | LPH, LZO, MEH |
| Legally marketed device(s) to | |
| which equivalence is claimed | Stryker Modular Dual Mobility (MDM) Liner (K103233, cleared February 3, |
Reference device: BI-MENTUM Dual Mobility System (K181744, cleared
December 11, 2018) |
| Reason for 510(k) submission | The subject devices are an addition to the DePuy PINNACLE Acetabular
implant portfolio, to provide a dual mobility construct for total hip
arthroplasty. |
| Device description | The DePuy PINNACLE Dual Mobility Liner is manufactured from cobalt-
chrome-molybdenum alloy. The Liner is assembled with a taper locking
mechanism to PINNACLE Acetabular Shells. The inner surface of the Dual
Mobility Metal Liner articulates with a BI-MENTUM polyethylene mobile |
| | bearing head. The Dual Mobility construct is compatible with DePuy metal
or ceramic modular femoral heads, for use in total hip arthroplasty. |
| Intended Use | The PINNACLE Dual Mobility Metal Liners are designed to provide
additional stability where there is an unstable joint and are for use in total hip
arthroplasty which is intended 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 PINNACLE Dual Mobility Metal Liners are intended for single use only. |
| Indications for use | Total hip replacement or hip arthroplasty is indicated in the following
conditions: |
| | 1. A severely painful and/or disabled joint (typically due to non
inflammatory degenerative joint disease).
2. Failed previous hip surgery.
3. Dislocation risks. |
| | PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE
Acetabular Cups are intended for cementless applications. |
4
5
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE
| PREDICATE DEVICE | |||
|---|---|---|---|
| Characteristics | Subject Device: | ||
| DePuy PINNACLE Dual Mobility | |||
| Insert | Predicate Device: | ||
| Stryker Modular Dual Mobility | |||
| Metal Liner | |||
| (K103233) | Reference Device: | ||
| BI-MENTUM Dual Mobility | |||
| System | |||
| (K181744) | |||
| Intended Use | The PINNACLE Dual Mobility Metal | ||
| Liners are designed to provide additional | |||
| stability where there is an unstable joint | |||
| and are for use in total hip arthroplasty | |||
| which is intended 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 PINNACLE Dual Mobility Metal | |||
| Liners are intended for single use only. | Total hip arthroplasty | Total hip replacement | |
| Liner Material | Cobalt-chrome-molybdenum alloy liner | Cobalt-chrome-molybdenum | |
| alloy liner | N/A – Device does not | ||
| incorporate a modular liner | |||
| Design | Modular dual articulation | Modular dual articulation | Monoblock dual articulation |
| Compatible | |||
| Acetabular | |||
| Shells | Porous Ti6Al4V Shells, sizes 48mm – | ||
| 72mm | Porous Ti6Al4V Shells, sizes | ||
| 44mm – 80mm | Stainless steel Shells with | ||
| commercially pure titanium and | |||
| hydroxyapatite coating, sizes | |||
| 41mm – 69mm | |||
| Compatible | |||
| Mobile | |||
| Bearing Heads | UHMWPE mobile bearing heads, | ||
| 22.2mm and 28mm IDs | UHMWPE mobile bearing heads, | ||
| 22.2mm and 28mm IDs | UHMWPE mobile bearing heads, | ||
| 22.2mm and 28mm IDs | |||
| Sterile Method | Gamma | Gamma | Gamma |
| Packaging | Double PETG blister with Tyvek peel lid | Double PETG blister with Tyvek | |
| peel lid | Shells: Double PETG blister with | ||
| Tyvek peel lid | |||
| Mobile bearing heads: Vacuum- | |||
| packed in bags and sealed in | |||
| blister packaging | |||
| Shelf Life | 10 years | 5 years | 5 years |
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The subject PINNACLE Dual Mobility Metal Liner has the same intended use, design, and material as the predicate Stryker Modular Dual Mobility Metal Liner (K10323). The subject device is intended for total hip arthroplasty; is a modular dual articulation construct; is made of cobalt-chromium-molybdenum alloy; and is available in the same as the predicate device. The subject PINNACLE Dual Mobility Metal Liner has the same intended use and is compatible with the same UHMWPE Mobile Bearing Heads as the reference device BI-MENTUM Dual Mobility System (K181744).
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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 Dual Mobility Metal Liner to demonstrate substantial equivalence of safety and efficacy with the predicate devices:
- Range of motion in accordance with ISO 21535:2007 / AMD 2016 .
- Verification of product compatibility ●
- Standard walking wear testing .
- Jump distance assessment .
- Mechanical testing in partial compliance with ASTM F1820 ●
- Taper performance testing ●
- The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSVAAMI ST72:2011 ●
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 PINNACLE Dual Mobility Metal Liners are substantially equivalent to the predicate Stryker Modular Dual Mobility Metal Liner.