(69 days)
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, rheumatoid 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, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Partial hip replacement is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
- Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
- Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.
The EMPHASYS Femoral Stems include HA-coated femoral stems in standard and high offsets and in collared and collarless configurations. The EMPHASYS Femoral Stems are designed to be used as one component of a system of prostheses in hip arthroplasty. The stems are compatible with a DePuy modular metal, dual mobility, or ceramic femoral head, and either a one-piece or a metal-backed two-piece acetabular component for use in total hip arthroplasty, and with a modular unipolar metallic femoral head or a modular bipolar head construct for hemi-hip arthroplasty.
The provided document is a 510(k) summary for a medical device (EMPHASYS Femoral Stems) and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that no clinical tests were conducted to demonstrate substantial equivalence.
Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth establishment for a study proving device performance against specified acceptance criteria.
The document discusses performance in terms of non-clinical tests for mechanical properties and biocompatibility. Here's a breakdown of what is present in the document related to "performance data" and "acceptance criteria" in a non-clinical context:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (against ISO standards) | Reported Device Performance (Conclusion) |
|---|---|
| Neck Fatigue (to ISO 7206-6: 2013) | Met (implied by "Testing... performed... to demonstrate substantial equivalence") |
| Distal Stem Fatigue (to ISO 7206-4: 2010) | Met (implied by "Testing... performed... to demonstrate substantial equivalence") |
| Range of Motion (to BS EN ISO 21535: 2009) | Met (implied by "Testing... performed... to demonstrate substantial equivalence") |
| Taper equivalence | Met (implied by "Testing... performed... to demonstrate substantial equivalence") |
| Biocompatibility evaluation (to ISO 10993-1:2018) | Met (implied by "Biocompatibility evaluation was carried out... and testing was carried out to include genotoxicity... cytotoxicity... sensitization... pyrogenicity... and chemical characterization") |
| Genotoxicity (to ISO 10993-3:2014) | Met (implied by "testing was carried out to include genotoxicity") |
| Cytotoxicity (to ISO 10993-5:2009) | Met (implied by "testing was carried out to include cytotoxicity") |
| Sensitization (to ISO 10993-10:2010) | Met (implied by "testing was carried out to include sensitization") |
| Pyrogenicity (to ISO 10993-11:2017) | Met (implied by "testing was carried out to include pyrogenicity") |
| Chemical Characterization (to ISO 10993-18:2020) | Met (implied by "testing was carried out to include chemical characterization") |
| Bacterial Endotoxin Testing (to ANSI/AAMI ST 72:2019) | Met ("The proposed devices also meet the requirement of bacterial endotoxin testing") |
| MRI Safety Evaluation (following ASTM F2503-13) | "No safety issues related to magnetic field interactions under specific conditions identified in the labelling." |
| Magnetic Induced Force (ASTM F2213-17) | Evaluated (worst-case components and constructs) |
| Image Artefact (ASTM 2119-07 (reapproved 2013)) | Evaluated (worst-case components and constructs) |
| RF Heating (ASTM F2182-19) | Evaluated (worst-case components and constructs) |
| Hydroxyapatite characterization data (FDA Guidance) | Provided |
Regarding the study that proves the device meets acceptance criteria (for clinical performance):
The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence."
Therefore, the following information cannot be provided from this document:
- 2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 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: Not applicable. This device is a hip implant, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable for clinical performance. For non-clinical tests, the ground truth is established by the specified ISO/ASTM standards and internal compliance.
- 8. The sample size for the training set: Not applicable as no clinical study with training data was conducted.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission relies on non-clinical performance data and a comparison of technological characteristics to a legally marketed predicate device to establish substantial equivalence, rather than a clinical study demonstrating performance against specific clinical acceptance criteria.
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August 5, 2021
DePuy Ireland UC % Clare Hill Senior Manager, Regulatory Affairs, CRO Regulatory Affairs DePuy Synthes, IRenc. 700 Orthopaedic Drive Warsaw, Illinois 46582
Re: K211657
Trade/Device Name: EMPHASYS Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, KWL, KWL, KWY, MEH Dated: May 27, 2021 Received: May 28, 2021
Dear Clare 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 (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 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.
Limin Sun 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211657
Device Name EMPHASYS Femoral Stems
Indications for Use (Describe)
INDICATIONS
Total hip replacement is indicated in the following conditions:
-
A severely painful and/or disabled joint from osteoarthritis, rheumatoid 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, internal fixation, arthrodesis, surface
replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
Partial hip replacement is indicated in the following conditions:
-
Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated fixation.
-
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
-
- Avascular necrosis of the femoral head.
-
- Non-union of femoral neck fractures.
-
Certain high subcapital and femoral neck fractures in the elderly.
-
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
-
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemiarthroplasty.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| X Prescription Hos (Dart 21 CED 801 Subnart D) | Over-The-Counter Use (21 CED 801 Subnart C) |
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510(K) SUMMARY
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Ireland UC |
| Address | Loughbeg, RingaskiddyCo. Cork Munster, IRELAND |
| Phone number | 574-404-8782 |
| Establishment RegistrationNumber | 1818910 |
| Name of contact person | Clare Hill |
| Date prepared | 25 May 2021 |
| Name of device | |
| Trade or proprietary name | EMPHASYS Femoral Stems |
| Common or usual name | Total or Hemi-Hip Arthroplasty Prosthesis |
| Classification name | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented OrNon-Porous, UncementedProsthesis, Hip, Hemi-, Femoral, MetalProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis |
| Product Code(s) | LZO, KWL, KWY, MEH |
| Legally marketed device(s) towhich equivalence is claimed | DePuy Corail AMT Hip Prosthesis (K190344) – Primary predicateCorail AMT Hip Prosthesis (K042992)DePuy Corail AMT Hip Prosthesis (K123991)DePuy Corail AMT Hip Prosthesis (K173960)DePuy Corail AMT Hip Prosthesis (K192946)Summit Hip System (K001991) |
| Summit Hip System (K170339) | |
| Actis DuoFix Hip Prosthesis - Collarless (K210581) | |
| Reason for 510(k) submission | The purpose of this submission is to obtain market clearance for theEMPHASYS Femoral Stems, one component of a system of prostheses usedin hip arthroplasty. |
| Device description | The EMPHASYS Femoral Stems include HA-coated femoral stems instandard and high offsets and in collared and collarless configurations.The EMPHASYS Femoral Stems are designed to be used as one componentof a system of prostheses in hip arthroplasty. The stems are compatible with aDePuy modular metal, dual mobility, or ceramic femoral head, and either aone-piece or a metal-backed two-piece acetabular component for use in totalhip arthroplasty, and with a modular unipolar metallic femoral head or amodular bipolar head construct for hemi-hip arthroplasty. |
| Intended use of the device | Total and Hemi Hip Arthroplasty |
| 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.Partial hip replacement is indicated in the following conditions:1. Acute fracture of the femoral head or neck that cannot beappropriately reduced and treated with internal fixation.2. Fracture dislocation of the hip that cannot be appropriately reducedand 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 theacetabulum does not require replacement.7. Pathology involving only the femoral head/neck and/or proximalfemur that can be adequately treated by hip hemiarthroplasty. |
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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The subject EMPHASYS Femoral Stems are similar to the predicate CORALL AMT Hip Prosthesis (K042992, K123960, K190344) in intended use, indications for use, design. The subject and predicate systems are intended for total or hemi hip arthroplasy and have the same indications for use. Both are forged titanium alloy. HA coated stems for uncemented use with a taper. Both devices have the same size tapers, and both are offered in collaress, standard offset and high offset configurations. Both devices are used in a modular hip construct which includes DePuy femoral head and acetabular components. The design of the subject and predicate devices is similar in terms of shape and function the intraosseous geometry of the subject devices has a narrower ML profile in places and is shorter than the predicate stems. The subject devices are offered in a 130° neck angle that is in between the two angles offered by the predicate devices.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Testing and engineering analyses were performed on the EMPHASYS Femoral Stems to demonstrate substantial equivalence of safety and efficacy with the predicate device, addressing:
- Neck Fatigue (to ISO 7206-6: 2013) .
- Distal Stem Fatigue (to ISO 7206-4: 2010) .
- Range of Motion (to BS EN ISO 21535: 2009) .
- Taper equivalence
Biocompatibility evaluation was carried out to ISO 10993-1:2018 and testing was carried out to include genotoxicity to ISO 10993-3:2014, cytotoxicity to ISO 10993-5:2009, sensitization to ISO 10993-10:2010, pyrogenicity to ISO 10993-11:2017 and chemical characterization to ISO 10993-18:2020.
The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI/AAMI ST 72:2019.
Magnetic Resonance Imaging safety evaluation testing was performed following ASTM F2503-13, and the tests evaluated the worst-case components and constructs for magnetically induced force (ASTM F2213-17), image artefact (ASTM 2119-07 (reapproved 2013)) and RF heating (ASTM F2182-19). The testing concluded that there are no safety issues related to magnetic field interactions under specific conditions identified in the labelling.
Hydroxyapatie characterization data, as recommended in the FDA Guidance 510(k) Information needed for Hydrosyapatite coated Orthopedic Implants, is provided.
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 EMPHASYS Femoral Stems are substantially equivalent to the predicate CORAIL AMT Hip Prosthesis.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.