(184 days)
No
The document describes a mechanical implant (acetabular insert) and its intended use and testing. There is no mention of AI, ML, image processing, or any software component that would suggest the use of these technologies.
Yes
The device is described as "prosthetic replacement" for treating various joint diseases and failed surgeries, which falls under the definition of a therapeutic device.
No
The device description indicates that the Klassic HD® Acetabular Insert with XLPE is a "permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty." This describes a prosthetic device used for treatment, not a device that diagnoses medical conditions.
No
The device description clearly states it is a permanently implanted device made from UHMWPE, indicating it is a physical implant, 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 describes a prosthetic replacement for the hip joint to treat various conditions. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a permanently implanted acetabular bearing surface for total hip arthroplasty. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- · Those patients with failed previous surgery where pain, deformity or dysfunction persists.
- · Revision of a previously failed hip arthroplasty.
- · Patients who require a total hip replacement.
Product codes
LPH, MBL, LWJ, LZO
Device Description
The Total Joint Orthopedics Klassic HD® Acetabular Insert with XLPE ("Insert with XLPE") is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with XLPE is fully compatible for use with the previously cleared Klassic HD® Hip System and is manufactured from UHMWPE crosslinked by gamma irradiation. The Insert with XLPE is sterilized by ethylene oxide gas and intended for single-use only.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench testing was conducted on the Klassic HD® Acetabular Insert with XLPE to support a determination of substantial equivalence to the predicate devices. Testing included extensive material characterization both before and after accelerated aging, sterility validation, and Push Out, Lever Out, Axial Torque Disassembly and Impingement testing with the Klassic HD® acetabular cup, femoral stem and femoral head. Bench testing results demonstrated that the Klassic HD® Acetabular Insert with XLPE is substantially equivalent and does not raise new questions of safety or effectiveness for total hip joint replacement when compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human face or profile, with three overlapping shapes suggesting multiple faces or a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2016
Total Joint Orthopedics, Inc. Mr. Chris Weaber Manufacturing Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106
Re: K161073
Trade/Device Name: Klassic HD® Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/ polymer/metal semi-constrained porous-coated uncemented prothesis Regulatory Class: Class II Product Code: LPH, MBL, LWJ, LZO Dated: September 16, 2016 Received: September 19, 2016
Dear Mr. Weaber:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) Unknown K161073
Device Name Klassic HD® Hip System
Indications for Use (Describe)
The Klassic HD® Hip System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NDJD): avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis.
- · Those patients with failed previous surgery where pain, deformity or dysfunction persists.
- · Revision of a previously failed hip arthroplasty.
- · Patients who require a total hip replacement.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Device Trade Name: | Klassic HD® Hip System |
|---|---|
| Manufacturer: | Total Joint Orthopedics, Inc. |
| 1567 E. Stratford Avenue | |
| Salt Lake City, UT 84106 | |
| U.S.A. | |
| Phone: 801.486.6070 | |
| FAX: 801.486.6117 | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: 202.552.5800 | |
| Fax: 202.552.5798 | |
| Date Prepared: | April 15, 2016 |
| Common Name: | Hip prosthesis, UHMWPE acetabular insert |
| Classification: | 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 | |
| 21 CFR 888.3360 Hip Joint femoral (Hemi-hip) metallic | |
| cemented or uncemented | |
| Class: | Class II |
| Product Codes: | LPH, MBL, LWJ, LZO |
Indications for Use:
The Klassic HD® Hip System is intended for prosthetic replacement without bone cement in treatment of the following:
- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): ● avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis. ●
- Those patients with failed previous surgery where pain, deformity or dysfunction . persists.
- . Revision of a previously failed hip arthroplasty.
- Patients who require a total hip replacement. .
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Device Description:
The Total Joint Orthopedics Klassic HD® Acetabular Insert with XLPE ("Insert with XLPE") is a permanently implanted device for use as an acetabular bearing surface in total hip arthroplasty ("THA"). The Insert with XLPE is fully compatible for use with the previously cleared Klassic HD® Hip System and is manufactured from UHMWPE crosslinked by gamma irradiation. The Insert with XLPE is sterilized by ethylene oxide gas and intended for single-use only.
Predicate Devices:
Reference Devices:
- Ortho Development Corporation Escalade Acetabular Cup System (K103384)
- Wright Medical Technology, Inc. LINEAGE® A-CLASS™ (K052026) .
Non-Clinical Testing
Non-clinical bench testing was conducted on the Klassic HD® Acetabular Insert with XLPE to support a determination of substantial equivalence to the predicate devices. Testing included extensive material characterization both before and after accelerated aging, sterility validation, and Push Out, Lever Out, Axial Torque Disassembly and Impingement testing with the Klassic HD® acetabular cup, femoral stem and femoral head. Bench testing results demonstrated that the Klassic HD® Acetabular Insert with XLPE is substantially equivalent and does not raise new questions of safety or effectiveness for total hip joint replacement when compared to the predicate devices.
Substantial Equivalence
The Klassic HD® Acetabular Insert with XLPE is substantially equivalent to the predicate devices based on indications for use, technological characteristics, design, material, mechanical performance testing, packaging and sterilization. The information summarized in the performance testing demonstrates that the Klassic HD® Acetabular Insert with XLPE met the pre-determined acceptance criteria. Additionally, LAL testing has been performed to establish that the Klassic HD® Acetabular Inserts with XLPE meet the specified 20EU/device limit.