(255 days)
No
The summary describes a traditional mechanical hip replacement system and does not mention any AI or ML components or functionalities.
Yes
The device is a total hip arthroplasty system, which is used to replace articulating surfaces of the hip joint, alleviating pain and restoring function—a clear therapeutic intervention.
No
This device is a total hip arthroplasty system, an implantable medical device used for the replacement of hip joint articulating surfaces. It is a treatment device, not a diagnostic one.
No
The device description clearly states it includes femoral and acetabular components, which are physical implants. The performance studies also focus on wear testing and material characterization of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for replacing the hip joint to treat various musculoskeletal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a total hip replacement system (femoral and acetabular components, liners, cups). This aligns with a surgical implant, not a device used to perform tests on biological samples.
- No mention of in vitro testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Performance Studies: The performance studies listed are related to the mechanical properties and biocompatibility of the implant materials (wear testing, material characterization), which are relevant for surgical devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
LPH, LZO
Device Description
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).
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
Not Found
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
The following tests were completed to support the addition of a 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 for wear-testing machines and corresponding environmental conditions for test ISO 14242-2: 2016 Implants For Surgery -
ISO 10993-17 Biological evaluation of medica devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18, 2005, Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials
Material Characterization per:
ASTM F2565 Standard Guide For Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms For Surgical Implant Applications
Clinical Testing was not required for these products.
Key Metrics
Not Found
Predicate Device(s)
Responsive Orthopedics Total Hip Arthroplasty System (K163585)
Reference Device(s)
Not Found
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
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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 Energy
180 International Drive
Portsmouth, NH 03801 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gina Cunsolo
Regulatory Affairs Specialist
Phone: (603) 842-6210
Fax: (603) 742-1488
E-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 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). |
| Indications for Use: | The Medtronic Total Hip Arthroplasty System is indicated for
cementless 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. |
| Technological Characteristics: | The Medtronic Total Hip Arthroplasty System is similar to that
of the predicate devices, as it still has the same indications for
use and intended use of the predicate. The difference between
the two is the material change of the acetabular liner from a
conventional polyethylene to a highly crosslinked UHMWPE
liner. |
| Summary of Non-Clinical
Testing: | The following tests were completed to support the addition of
a 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 for
wear-testing machines and corresponding
environmental conditions for test ISO 14242-2: 2016 Implants For Surgery -
|
| ο | ISO 10993-17 Biological evaluation of medica
devices - Part 17: Establishment of allowable
limits for leachable substances |
| ο | ISO 10993-18, 2005, Biological Evaluation of
Medical Devices - Part 18: Chemical
Characterization of Materials |
| - | Material Characterization per: |
| ο | ASTM F2565 Standard Guide For Extensively
Irradiation-Crosslinked Ultra-High Molecular
Weight Polyethylene Fabricated Forms For
Surgical 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 Hip
Arthroplasty System, the subject device is equivalent to the
predicate device. |
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