(97 days)
Not Found
No
The 510(k) summary describes a mechanical hip implant system and its components. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical testing and engineering analyses.
Yes
The device is a prosthetic replacement intended to treat various joint diseases and correct hip deformities, which aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
Explanation: The device is a prosthetic hip system intended for surgical replacement of the hip joint, not for diagnosing conditions.
No
The device description clearly states it is a prosthesis, which 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 surgical implant for replacing the hip joint in patients with various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a prosthesis designed to restore hip joint biomechanics. This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body to treat a condition.
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 (NID)D): 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 (comma separated list FDA assigned to the subject device)
LPH, LZO, MBL
Device Description
The Klassic HD® Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum. leg length. offset and version. The purpose of this 510(k) is to add Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems to the Klassic HD® Hip System. The modified stems can be mated with the previously cleared metal (CoCrMo) or ceramic femoral heads and UHMWPE acetabular components of the Klassic HD® Hip System.
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)
The company performed Range of Motion and worst case fatigue testing of the Klassic Blade Femoral Stems and Klassic® Blade Offset Femoral Stems. Engineering analyses were conducted to evaluate disassembly properties and porous coating properties of the Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems. The test results and analyses demonstrated that the modified stems are substantially equivalent to the predicate components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
September 3, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Total Joint Orthopedics, Incorporated Mr. Chris Weaber Manufacturing Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106
Re: K151440 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 prosthesis Regulatory Class: Class II Product Code: LPH Dated: August 6, 2015 Received: August 7, 2015
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,
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 K151440
Device Name Klassic HDTM 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 (NID)D): 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 1.
| Manufacturer: | Total Joint Orthopedics, Inc.
1567 E. Stratford Avenue
Salt Lake City, UT 84106
Phone: 801.486.6070
Fax: 801.486.6117 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber
Manufacturing Development Engineer |
| 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: | May 28, 2015 |
| Device Trade Name: | Klassic HD® Hip System |
| Common Name: | Femoral Hip Stem |
| Classifications: | 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 |
| | Class II |
| Product Codes: | LPH, LZO, MBL |
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 Klassic HD® Hip System employs a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing the size of the femur and acetabulum. leg length. offset and version. The purpose of this 510(k) is to add Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems to the Klassic HD® Hip System. The modified stems can be mated with the previously cleared metal (CoCrMo) or ceramic femoral heads and UHMWPE acetabular components of the Klassic HD® Hip System.
Predicate Devices:
The modified Klassic HD® Hip System is substantially equivalent to the predicate Klassic HD® Hip System (K100445), Klassic HD® Offset Femoral Stem (K133832), and Klassic HD® Extended Offset Femoral Head (K131454) with respect to indications, design, and function.
Substantial Equivalence:
The company performed Range of Motion and worst case fatigue testing of the Klassic Blade Femoral Stems and Klassic® Blade Offset Femoral Stems. Engineering analyses were conducted to evaluate disassembly properties and porous coating properties of the Klassic® Blade Femoral Stems and Klassic® Blade Offset Femoral Stems. The test results and analyses demonstrated that the modified stems are substantially equivalent to the predicate components.