(255 days)
The Medtronic Total Hip Arthroplasty System is indicated for cement-less use only in the following cases:
- . Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and
- Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
The Medtronic Total Hip Arthroplasty System Acetabular Screws are intended for supplemental fixation of the associated Medtronic Acetabular Cup.
The Medtronic Total Hip Arthroplasty System is a total hip system for the restoration of alignment, stability range of motion, and alleviation of pain, by replacing the articulating surfaces of the hip joint. The system includes femoral and acetabular components. The implants are available in a variety of sizes to accommodate varying patient anatomy.
New acetabular components including highly crosslinked UHMWPE acetabular liners and porous coated cups are the subject of this 510(k).
I am sorry, but the provided text does not contain information about an AI/ML-based medical device. The document is an FDA 510(k) clearance letter for the Medtronic Total Hip Arthroplasty System, a physical medical device (hip prosthesis).
Therefore, I cannot provide details on acceptance criteria, study methodologies, or performance related to AI/ML models as these elements are not present in the document. The document explicitly states: "Clinical Testing was not required for these products." and focuses on non-clinical (bench) testing for the hip implant's materials and wear characteristics.
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Medtronic Advanced Energy Gina Cunsolo Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801
Re: K183129
Trade/Device Name: Medtronic Total Hip Arthroplasty 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 25, 2019 Received: June 26, 2019
Dear Gina Cunsolo:
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.
July 26, 2019
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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
Ve
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
The following is the Indications for Use Statement. Refer to Attachment 1 for FDA Form 3881.
Device Name:
Medtronic Total Hip Arthroplasty System
Indications:
The Medtronic Total Hip Arthroplasty System is indicated for cement-less use only in the following cases:
- . Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and
- Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques
The Medtronic Total Hip Arthroplasty System Acetabular Screws are intended for supplemental fixation of the associated Medtronic Acetabular Cup.
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510(k) Summary
| Submitter: | Medtronic Advanced Energy180 International DrivePortsmouth, NH 03801 |
|---|---|
| Contact Person: | Gina CunsoloRegulatory Affairs SpecialistPhone: (603) 842-6210Fax: (603) 742-1488E-mail: Gina.M.Cunsolo@medtronic.com |
| Date Summary Prepared: | November 9, 2018 |
| Device Trade Name: | Medtronic Total Hip Arthroplasty System |
| Common Name: | Hip Prosthesis |
| Classification Name: | 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis |
| 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis | |
| Product Code: | LPH, LZO |
| Predicate Devices: | Responsive Orthopedics Total Hip Arthroplasty System(K163585) |
| Device Description: | The Medtronic Total Hip Arthroplasty System is a total hipsystem for the restoration of alignment, stability range ofmotion, and alleviation of pain, by replacing the articulatingsurfaces of the hip joint. The system includes femoral andacetabular components. The implants are available in a varietyof sizes to accommodate varying patient anatomy. |
| New acetabular components including highly crosslinkedUHMWPE acetabular liners and porous coated cups are thesubject of this 510(k). | |
| Indications for Use: | The Medtronic Total Hip Arthroplasty System is indicated forcementless use only in the following cases:Noninflammatory degenerative joint disease includingosteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments ordevices have failed; and Nonunions, femoral neck and trochanteric fractures ofthe proximal femur with head involvement that areunmanageable using other techniques |
| The Medtronic Total Hip Arthroplasty System AcetabularScrews are intended for supplemental fixation of theassociated Medtronic Acetabular Cup. | |
| Technological Characteristics: | The Medtronic Total Hip Arthroplasty System is similar to thatof the predicate devices, as it still has the same indications foruse and intended use of the predicate. The difference betweenthe two is the material change of the acetabular liner from aconventional polyethylene to a highly crosslinked UHMWPEliner. |
| Summary of Non-ClinicalTesting: | The following tests were completed to support the addition ofa highly crosslinked UHMWPE acetabular liner and cup:Wear Testing per: ISO 14242-1:2014 Implants for Surgery -Wear of total hip-joint prostheses - Part 1:Loading and displacement parameters forwear-testing machines and correspondingenvironmental conditions for test ISO 14242-2: 2016 Implants For Surgery - |
| ο | ISO 10993-17 Biological evaluation of medicadevices - Part 17: Establishment of allowablelimits for leachable substances |
| ο | ISO 10993-18, 2005, Biological Evaluation ofMedical Devices - Part 18: ChemicalCharacterization of Materials |
| - | Material Characterization per: |
| ο | ASTM F2565 Standard Guide For ExtensivelyIrradiation-Crosslinked Ultra-High MolecularWeight Polyethylene Fabricated Forms ForSurgical Implant Applications |
| Summary of Clinical Tests: | Clinical Testing was not required for these products. |
| Conclusion: | Based on the indications for use, performance characteristics,and bench testing completed on the Medtronic Total HipArthroplasty System, the subject device is equivalent to thepredicate device. |
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§ 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.