(86 days)
No
The document describes a mechanical hip implant and its performance testing, with no mention of AI or ML technologies.
Yes
The Klassic HD Hip System is intended for prosthetic replacement to treat various degenerative and inflammatory joint diseases, indicating its use in restoring or improving physical function and well-being.
No
The device is a prosthetic hip replacement system, intended for treatment of joint diseases and failed surgeries, not for diagnosing conditions.
No
The device description clearly states it is a "femoral component" and describes physical characteristics like porous/non-porous options, sizes, sterilization, and single-use. The performance studies also focus on physical testing of the stem (fatigue, disassembly, range of motion). This indicates a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Klassic HD Hip System is a prosthetic replacement for the hip joint. It is a physical implant used within the body to treat various hip conditions.
- Lack of Biological Sample Testing: There is no mention of this device being used to test biological samples or provide diagnostic information based on such testing.
Therefore, the Klassic HD Hip System falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Klassic HDTM 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. ●
Product codes
LPH, MBL, LWJ
Device Description
The Klassic HD Offset Femoral Stem is a femoral component to be used within the Klassic HD Hip System as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by helping to achieve proper leg length and offset. The Klassic HD Offset Femoral Stem is offered in both porous and non-porous options. Each configuration of the Klassic HD Offset Femoral Stem is offered in 9 sizes, is sterilized by gamma irradiation and is 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 testing was conducted on the Klassic HD Offset Femoral Stem to support a determination of substantial equivalence to the predicate devices. Non-clinical testing was based off of guidance from:
- Guidance for Industry and FDA Staff Non-clinical Information for . Femoral Stem Prostheses, Document 1647 dated September 17, 2007
- . ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components
The performance testing for the Klassic HD Offset Femoral Stem consisted of neck and stem fatigue testing, axial and torsional disassembly evaluation and range of motion determination. The porous coating properties for the Klassic HD Offset Femoral Stem Porous are identical to that of the Klassic HD Femoral Stem Porous. All bench testing and evaluation demonstrates the Klassic HD Offset Femoral Stem is equivalent in regards to safety and efficacy, is suitable for Total Hip Arthroplasty and is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) SUMMARY
510(k) Notification K133832 (pg 1/3)
GENERAL INFORMATION
Applicant:
Total Joint Orthopedics, Inc. 1567 E Stratford Avenue Salt Lake City, UT 84106 United States Phone: 801-486-6070 Fax: 801-486-6117
Contact Person:
Ben Casey Product Development Engineer Total Joint Orthopedics l 567 E. Stratford Avenue Salt Lake City, UT 84106 United States Phone: 801-486-6070 FAX: 801-486-6117
Date Prepared: December 16, 2013
DEVICE INFORMATION
The Klassic HD™ Offset Femoral Stem is a modular femoral prosthesis to be used within the Klassic HD™ Hip System to help surgeons restore hip joint biomechanics intraoperatively by helping to achieve proper leg length and offset in total hip arthroplasty.
Trade Name: Klassic HD™ Offset Femoral Stem
Generic/Common Name: Femoral Hip Stem
Classification:
21 CFR § 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product Code: LPH, MBL, LWJ
1
510(k) Summary
PREDICATE DEVICES
The Klassic HD Offset Femoral Stem is substantially equivalent in intended use, design, function and performance testing to the following predicate devices:
- Klassic HD Hip System Total Joint Orthopedics K100445 .
- Alloclassic Zweymuller SL Offset Femoral Stem Centerpulse . Orthopedics K033664
INTENDED USE
The Klassic HDTM 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 (ID): 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 DESCRIPTION
The Klassic HD Offset Femoral Stem is a femoral component to be used within the Klassic HD Hip System as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by helping to achieve proper leg length and offset. The Klassic HD Offset Femoral Stem is offered in both porous and non-porous options. Each configuration of the Klassic HD Offset Femoral Stem is offered in 9 sizes, is sterilized by gamma irradiation and is intended for single-use only.
TECHNOLOGICAL CHARACTERISTICS
The Offset Femoral Stem is a monolithic, titanium alloy, Zweymuller blade type stem featuring a neck shaft angle of 121° and increased lateral offset compared to the 131° neck shaft angle from the Klassic HD Femoral Stem. The Klassic HD Offset Femoral Stem utilizes the identical body geometry as the Klassic HD Femoral Stem, distal to the line of resection; along with the identical Ti6Al4V material and porous coated options.
The neck shaft angle of 121° and increased neck length are similar to the Alloclassic Zweymuller SL Offset Femoral Stem featuring a neck angle of 121° and 6.25mm increased lateral offset versus its predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Non-clinical testing was conducted on the Klassic HD Offset Femoral Stem to support a determination of substantial equivalence to the predicate devices. Non-clinical testing was based off of guidance from
2
510(k) SUMMARY
- Guidance for Industry and FDA Staff Non-clinical Information for . Femoral Stem Prostheses, Document 1647 dated September 17, 2007
- . ASTM F1814-97a - Standard Guide for Evaluating Modular Hip and Knee Joint Components
The performance testing for the Klassic HD Offset Femoral Stem consisted of neck and stem fatigue testing, axial and torsional disassembly evaluation and range of motion determination. The porous coating properties for the Klassic HD Offset Femoral Stem Porous are identical to that of the Klassic HD Femoral Stem Porous. All bench testing and evaluation demonstrates the Klassic HD Offset Femoral Stem is equivalent in regards to safety and efficacy, is suitable for Total Hip Arthroplasty and is substantially equivalent to predicate devices.
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Klassic HD Offset Femoral Stem. The Klassic HD Offset Femoral stem is similar to the predicate devices based on technological characteristics, design, non-clinical performance testing, material 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 HD Offset Femoral Stem is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2014
Total Joint Orthopedics, Inc. Mr. Ben Casey Product Development Engineer 1567 E. Stratford Avenue Salt Lake City, Utah 84106
Re: K133832
Trade/Device Name: Klassic HD™ Offset Femoral Stem 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, MBL, LWJ Dated: December 16, 2013 Received: December 17, 2013
Dear Mr. Casey:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Ben Casey
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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. Wigqins
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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TOTAL JOINT ORTHOPEDICS, INC.
KLASSIC HD™ OFFSET FEMORAL STEM 510(k) PREMARKET NOTIFICATION
SECTION 4 INDICATIONS FOR USE STATEMENT
K133832 (pg 1/1) 510(k) Number (if known):
Device Name: Klassic HDTM Offset Femoral Stem
Indications For Use:
The Klassic HDTM 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. ●
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)
Elizabet旗峻Frank -S
Division of Orthopedic Devices