(92 days)
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatio arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
EMPHASYS Acetabular Cups are indicated for cementless use only.
The EMPHASYS Acetabular System includes porous-coated acetabular shells in three configurations (No-Hole, 3-Hole and Multi-Hole) and AOX polyethylene liners in three configurations (Neutral, +4 Neutral and ELV).
This is a K (Premarket Notification) document for the EMPHASYS Acetabular System, a medical device. The document does not describe acceptance criteria for a diagnostic/AI device or a study proving that such a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence of the subject device (an acetabular system for hip replacement) to legally marketed predicate devices through various performance tests.
Therefore, I cannot extract the information requested as it is not present in the provided document. The document primarily deals with the mechanical and material performance of a hip implant, not an AI or diagnostic device that would involve a test set, ground truth, or expert review.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2022
DePuy Ireland UC % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs MCRA, LLC 803 7th street, NW, 3rd Floor Washington, District of Columbia 20001
Re: K221636
Trade/Device Name: EMPHASYS Acetabular System 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 Dated: June 27, 2022 Received: June 27, 2022
Dear Hollace Rhodes:
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.
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K221636
Device Name EMPHASYS Acetabular System
Indications for Use (Describe)
Total hip replacement is indicated in the following conditions:
-
A severely painful and/or disabled joint from osteoarthritis, traumatio arthritis, or congenital hip dysplasia.
-
Avascular necrosis of the femoral head.
-
Acute traumatic fracture of the femoral head or neck.
-
Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
eplacement arthroplasty, or total hip replacement.
5. Casting or splinting.
- Certain cases of ankylosis.
EMPHASYS Acetabular Cups are indicated for cementless use only.
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)
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
| Submitter Information | |||
|---|---|---|---|
| Name | DePuy Ireland UC | ||
| Address | Loughbeg, Ringaskiddy | ||
| Co. Cork Munster, IRELAND | |||
| Phone number | 574-372-7211 | ||
| Fax number | 574-371-4987 | ||
| Establishment RegistrationNumber | 3015516266 | ||
| Submission Prepared by | MCRA | ||
| Address | 803 7th Street NW, 3rd Floor | ||
| Washington, DC 20001, USA | |||
| Phone number | 202-552-5800 | ||
| Name of contact person | Ms Hollace S Rhodes | ||
| Date prepared | 1 June 2022 | ||
| Name of device | |||
| Trade or proprietary name | EMPHASYS Acetabular System | ||
| Common or usual name | Total Hip Arthroplasty Prosthesis | ||
| Classification name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented OrNon-Porous, Uncemented | ||
| Class | II | ||
| Classification panel | 87 Orthopedics | ||
| Regulation | 888.3358; 888.3353 | ||
| Product Codes | LPH; LZO | ||
| Legally marketed devices towhich equivalence is claimed | Predicate | Reference Device | |
| EMPHASYSShell | DePuy PinnacleGription Acetabular Cups(K071784, K093646) | Stryker Trident SystemPSL shell(K983382) | |
| EMPHASYSLiner | DePuy PinnacleALTRX Acetabular Liners(K132959)DePuy PinnacleMarathon AcetabularLiners(K033273) | Stryker Trident SystemX3 Polyethylene Liner(K062419)DePuy ATTUNE AllPoly Tibia(K193057) |
Page 2 of 4
{4}------------------------------------------------
| Reason for 510(k) submission | The purpose of this 510(k) submission is to obtain market clearance for theDePuy EMPHASYS Acetabular System |
|---|---|
| Device description | The EMPHASYS Acetabular System includes porous-coated acetabular shellsin three configurations (No-Hole, 3-Hole and Multi-Hole) and AOXpolyethylene liners in three configurations (Neutral, +4 Neutral and ELV). |
| Intended use of the device | The system is intended for use with a compatible DePuy femoral stem andmodular head as a total hip prosthesis. |
| Indications for use | Total hip replacement is indicated in the following conditions:1. A severely painful and/or disabled joint from osteoarthritis, traumaticarthritis, rheumatoid arthritis, or congenital hip dysplasia.2. Avascular necrosis of the femoral head.3. Acute traumatic fracture of the femoral head or neck.4. Failed previous hip surgery including joint reconstruction, internalfixation, arthrodesis, hemiarthroplasty, surface replacementarthroplasty, or total hip replacement.5. Certain cases of ankylosis.EMPHASYS Acetabular Cups are indicated for cementless use only. |
| Performance Testing | The EMPHASYS Acetabular System was tested to demonstrate itssubstantial equivalence to the identified predicate devices. Testing andanalyses included:Range of motion per ISO 21535:2007 Analysis of shell and liner thickness Impingement per ASTM F2582-14 Deformation per ISO 7206-12:2016 Clearance between femoral head and liner Interconnection strength of shell and liner per ASTM F1820-13 andASTM F3090-20 Wear of aged and non-aged polyethylene per ISO 14242-1:2014,ISO 14242-2:2016 and ISO 14242-4:2018 Friction per ASTM F3143-20 Coating characterization per ASTM-F1160-14 and ASTM-F1147-05and FDA's "Guidance Document for Testing Orthopedic Implantswith Modified Metallic Surface Apposing Bone or Bone Cement" Polyethylene characterization per ASTM D638-14, ASTM F2625-10, ASTM F648-14, ASTM F2381-19, ASTM F2003-02, ASTMF2102-17, ASTM D1505-18, ASTM D2765, ASTM E647-95a,ASTM F648-14and FDA's guidance, “Characterization of UltrahighMolecular Weight Polyethylene (UHMWPE) Used in OrthopedicDevices” |
| MRI Safety per ASTM F2503-20, ASTM F2182 -19, ASTM F2052-15, ASTM F2213-17 and ASTM F2119-07 Bacterial endotoxins per ANSI/AAMI ST 72:2019 | |
| Substantial Equivalence | The EMPHASYS Acetabular System is substantially equivalent to theidentified predicates with respect to intended use, indications, materials,geometry, range of sizes, and method of fixation. Results of performancetesting and analyses demonstrate that the EMPHASYS Acetabular Systemperforms as well as the predicate devices. |
{5}------------------------------------------------
§ 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.