(90 days)
No
The document describes a mechanical implant system for hip replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an orthopedic implant (Bipolar System for hip hemiarthroplasty) designed to treat specific medical conditions, which inherently qualifies it as a therapeutic device.
No
The device is described as an implant used in hip hemiarthroplasty procedures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical implant components (BiPolar Head, Femoral Head) made of materials like UHMWPE, cobalt chrome, and Ti6A14V. This indicates a hardware-based medical device, not a software-only one.
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 treating conditions of the hip, specifically femoral fractures and osteonecrosis. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a hip implant (bipolar head, femoral head) made of materials like UHMWPE, cobalt chrome, and titanium. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical testing (fatigue, disassembly, range of motion) and demonstrating equivalence to predicate devices, which are typical for surgical implants.
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 Klassic TM BiPolar System is intended for use in combination with a Total Joint Orthopedics Femoral Stem for primary or revision hemiarthroplasty of the hip, without the use of bone cement, for treatment of the following conditions:
- o Femoral neck and trochanteric fractures of the proximal femur
- Osteonecrosis of the femoral head
- Revision procedures where other devices or treatments for these indications have failed.
Product codes
KWY
Device Description
The Klassic TM BiPolar System includes the Klassic TM BiPolar System BiPolar Head, Klassic TM BiPolar System Femoral Head (12-14 Taper), 22mm, and Klassic TM BiPolar System Femoral Head(12-14 Taper), 28mm implant components ("Klassic"") BiPolar System Implants").
The Klassic TM BiPolar System BiPolar Head includes a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner, cobalt chrome outer shell, and a UHMWPE retention ring with a Ti6A14V spring. The Bipolar Head includes an outer diameter range from 38 to 43 mm with an inner diameter which mates with the 22 mm femoral head, and an outer diameter range from 44 to 60 mm with an inner diameter which mates with the 28mm femoral head. The Bipolar Heads are offered in 1 mm outer diameter size increments.
The Klassic TM BiPolar System Femoral Heads include a 12/14 Taper for interfacing with TJO's Klassic HD TM Femoral Stems (K100445), and TJO's Klassic HD TM Offset Femoral Stems (K133832). These heads available with offsets of Neutral, +3.5mm and +7.0mm for the 22mm Femoral Head, and -3.5, Neutral, +3.5mm and +7.0mm for the 28mm Femoral Head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
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
Analysis for Non Clinical Testing, including fatigue, disassembly and range of motion, was completed to demonstrate that the Klassic TM BiPolar System did not create a new worst case.
All bench testing and supporting engineering evaluations demonstrate the Klassic TM BiPolar System Implants are equivalent in regards to safety and efficacy and are substantially equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
BioPro Bipolar Head - BioPro (K100761), BioPro Bipolar Femoral Head BioPro (K082785)
Reference Device(s)
Klassic HD Hip System Total Joint Orthopedics (K100445), Tandem BiPolar Hip System Smith & Nephew (K823726)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 28, 2015
Total Joint Orthopedics. Incorporated Mr. Chris Weaber Manufacturing Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106
Re: K143113 Trade/Device Name: Klassic TM BiPolar System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY Dated: October 29, 2014 Received: October 30, 2014
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
Page 2 – Mr. Chris Waeber
(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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K143113
Klassic™ BiPolar System:
Indications For Use:
The Klassic 110 BiPolar System is intended for use in combination with a Total Joint Orthopedics Femoral Stem for primary or revision hemiarthroplasty of the hip, without the use of bone cement, for treatment of the following conditions:
- o Femoral neck and trochanteric fractures of the proximal femur
- Osteonecrosis of the femoral head
- Revision procedures where other devices or treatments for these indications have failed.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) SUMMARY
510(k) Notification K
GENERAL INFORMATION
Applicant:
Total Joint Orthopedics 1567 E. Stratford Avenue Salt Lake City, UT 84106 United States Phone: 801-486-6070 FAX: 801-486-6117
Contact Person:
Chris Weaber Manufacturing Development Engineer Total Joint Orthopedics 1567 E. Stratford Avenue Salt Lake City, UT 84106 United States Phone: 801-486-6070 FAX: 801-486-6117
Date Prepared: October 29, 2014
DEVICE INFORMATION
Trade/Proprietary Name:
Klassic™ BiPolar System
Generic/Common Name:
Hemi-Hip prosthesis, uncemented
Classification:
21 CFR §888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
Product Code: KWY
4
510(k) SUMMARY
PREDICATE DEVICE(S)
The Klassic™ BiPolar System is substantially equivalent in intended use, design and function to the following primary predicate device:
The Klassic "11 BiPolar System is also substaintially equivalent in regards to technology characteristics to
- Klassic HD Hip System Total Joint Orthopedics (K100445) .
- Tandem BiPolar Hip System Smith & Nephew (K823726) ●
INTENDED USE
The Klassic 110 BiPolar System is intended for use in combination with a Total Joint Orthopedics Femoral Stem for primary or revision hemiarthroplasty of the hip, without the use of bone cement, for treatment of the following conditions:
- Femoral neck and trochanteric fractures of the proximal femur ●
- Osteonecrosis of the femoral head ●
- Revision procedures where other devices or treatments for these indications have ● failed.
PRODUCT DESCRIPTION
The Klassic™ BiPolar System includes the Klassic™ BiPolar System BiPolar Head, Klassic 110 BiPolar System Femoral Head (12-14 Taper), 22mm, and Klassic 100 BiPolar System Femoral Head(12-14 Taper), 28mm implant components ("Klassic"") BiPolar System Implants").
The Klassic"10 BiPolar System BiPolar Head includes a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner, cobalt chrome outer shell, and a UHMWPE retention ring with a Ti6A14V spring. The Bipolar Head includes an outer diameter range from 38 to 43 mm with an inner diameter which mates with the 22 mm femoral head, and an outer diameter range from 44 to 60 mm with an inner diameter which mates with the 28mm femoral head. The Bipolar Heads are offered in 1 mm outer diameter size increments.
The Klassic™ BiPolar System Femoral Heads include a 12/14 Taper for interfacing with TJO's Klassic HD10 Femoral Stems (K100445), and TJO's Klassic HD™ Offset Femoral Stems (K133832). These heads available with offsets of Neutral, +3.5mm and +7.0mm for the 22mm Femoral Head, and -3.5, Neutral, +3.5mm and +7.0mm for the 28mm Femoral Head.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Klassic"M BiPolar System Implants are substantially equivalent to predicate devices. The Bipolar Head, 22mm femoral head and 28 mm femoral head feature design, material of manufacture, sterilization and size offerings which are equivalent to predicate devices.
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510(k) SUMMARY
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Analysis for Non Clinical Testing, including fatigue, disassembly and range of motion, was completed to demonstrate that the Klassic™ BiPolar System did not create a new worst case.
All bench testing and supporting engineering evaluations demonstrate the Klassic™ BiPolar System Implants are equivalent in regards to safety and efficacy and are substantially equivalent to predicate devices.
SUBSTANTIAL EQUIVALENCE
The BiPolar Head is substantially equivalent to the predicate device, BioPro Bipolar (K100761). The indications for use for the BioPro BiPolar Head (K100761)predicate devices are substantially equivalent to the proposed indications for use for the Klassic™ BiPolar System Implants. The Klassic TM BiPolar System Implants are similar to the predicate devices based on technological characteristics, design, material, sterilization and intended use. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Klassic™ BiPolar System Implants are substantially equivalent to the predicate devices.