(289 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of the hip implant components, with no mention of AI or ML for diagnosis, treatment planning, or any other function.
Yes
The device is a prosthetic replacement for the hip joint, intended to treat various conditions that cause pain, deformity, or dysfunction. This directly aligns with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
The Klassic HD Hip System is a prosthetic hip replacement device, not a diagnostic tool. Its intended use is for the treatment of joint diseases by replacing the hip joint, not for diagnosing conditions.
No
The device description explicitly details physical, implantable components made of titanium alloy and cobalt chromium, which are hardware. The performance studies also focus on bench testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for prosthetic replacement of the hip joint in various patient conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a system of modular components for a cementless hip joint replacement. These are physical implants designed to replace anatomical structures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on in vitro testing.
This device is a surgical implant used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / 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. .
Product codes (comma separated list FDA assigned to the subject device)
LPH, MBL, LWJ
Device Description
The Klassic HD Hip System is simple, easy to use, and based on clinically proven design philosophies. 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 Klassic HD Hip System is comprised of modular components with varying sizes available for each component for a cementless hip joint replacement application. Components of the Klassic HD Hip System include the femoral stem, femoral head, femoral head adapter sleeve, acetabular cup, acetabular insert and cancellous bone screws. The implantable components are intended for single-use for a single patient only.
The titanium alloy femoral stems feature a neck shaft angle of 131°. Femoral stems are available in sizes 1-9 with neck lengths of 26-38mm in 4mm increments and stem lengths of 110-150mm in 5mm increments. The stem's proximal surface is either grit-blasted or porous-coated. Cobalt chromium femoral heads available in 32mm or 36mm diameters attach either directly to the stem trunnion or through the use of an adapter sleeve thereby offering -3.5mm, neutral, +3.5mm and +7mm offsets. The titanium alloy, hemispherical acetabular cups are available in 9 sizes ranging from 48-64mm in 2mm increments and incorporate a porous coated outer surface. The UHMWPE acetabular inserts attach through a snap-fit mechanism to the acetabular cup. Conventional, noncross-linked (32mm inner diameter) and cross-linked (32mm and 36mm inner diameter) UHMWPE insert versions are available in the Klassic HD Hip System. Both types of UHMWPE material have been utilized in previously cleared devices. Optional 6.5mm cancellous, titanium alloy bone screws allow for additional fixation of the acetabular cup to the bone.
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)
Extensive bench testing was conducted on the Klassic HD Hip System to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate devices. Performance testing conducted for the worst case femoral constructs addressed proximal fatigue, distal fatigue, axial disassembly and torsional disassembly. Performance testing conducted for the worst case acetabular constructs included push-out, lever-out and torque to rotation testing as well as an evaluation of wear characteristics of the insert materials. The static breaking strength and the pull-out strength of the worst case cancellous bone screw were also assessed. The porous coating was characterized per FDA's "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Opposing Bone or Bone Cement" dated April 28, 1994.
All testing was performed in accordance with recognized standards. Results confirm that all components of the Klassic HD Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement, and are substantially equivalent to the predicate devices.
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.
K073068, K030373, K991226, K051737, K082844, K072888, K092386, K031110, K062489, K073150
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
TOTAL JOINT ORTHOPEDICS, INC.
KLASSIC HD™ HIP SYSTEM 510(k) PREMARKET NOTIFICATION
510(k) Summary
510(k) Notification K100445
GENERAL INFORMATION
Applicant: Total Joint Orthopedics, Inc. 1567 E Stratford Ave Salt Lake City, UT 84106 Phone: 801-486-6070 Fax: 801-486-6117
Contact Person:
Kit Cariquitan Vice President, Regulatory Affairs Experien Group, LLC 155-A Moffett Park Drive Suite 210 Sunnyvale, CA 94089 Phone: 408-400-0856 Fax: 408-400-0865
Date Prepared: October 22, 2010
DEVICE INFORMATION
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.
Classification:
21 CFR§888.3358, Class II
Product Code:
LPH, MBL, LWJ
Trade Name:
Klassic HD™ Hip System
Generic/Common Name:
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
DEC - 3 2010
1
510(k) SUMMARY (CONT.)
PREDICATE DEVICES
- Accelerated Innovation, L.L.C., Accin™ Hip System (K073068) .
- Centerpulse Orthopedics Ltd., Alloclassic" Zweymueller" SL/SLL Femoral Stem . (K030373)
- Encore Orthopedics, Inc., Foundation® Porous Hip Stem (K991226) .
- Howmedica Osteonics Corp., V-40" /C-Taper Adapter Sleeve (K051737) .
- Encore Medical, L.P., Biolox® delta Ceramic Femoral Head and Biolox® delta . Ceramic Femoral Offset Sleeve (K082844)
- Encore Medical, L.P., Foundation® Porous Coated (FMP™) Acetabular Shells . (K072888)
- Smith & Nephew, Inc., R3 Multi-Hole Shells and 36mm XLPE Acetabular Liners . (K092386)
- Apex Surgical, LLC, Apex Modular™ Acetabular Cup (K031110) .
- OMNI Life Science, Inc., Apex HCLATM Acetabular Cup Liners (K062489) .
- OMNI Life Science, Inc., ApeX-LNK Poly™ Acetabular Cup Liners (K073150) .
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. .
PRODUCT DESCRIPTION
The Klassic HD Hip System is simple, easy to use, and based on clinically proven design philosophies. 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 Klassic HD Hip System is comprised of modular components with varying sizes available for each component for a cementless hip joint replacement application. Components of the Klassic HD Hip System include the femoral stem, femoral head, femoral head adapter sleeve, acetabular cup, acetabular insert and cancellous bone screws. The implantable components are intended for single-use for a single patient only.
The titanium alloy femoral stems feature a neck shaft angle of 131°. Femoral stems are available in sizes 1-9 with neck lengths of 26-38mm in 4mm increments and stem lengths
2
510(k) Summary (Cont.)
of 110-150mm in 5mm increments. The stem's proximal surface is either grit-blasted or porous-coated. Cobalt chromium femoral heads available in 32mm or 36mm diameters attach either directly to the stem trunnion or through the use of an adapter sleeve thereby offering -3.5mm, neutral, +3.5mm and +7mm offsets. The titanium alloy, hemispherical acetabular cups are available in 9 sizes ranging from 48-64mm in 2mm increments and incorporate a porous coated outer surface. The UHMWPE acetabular inserts attach through a snap-fit mechanism to the acetabular cup. Conventional, noncross-linked (32mm inner diameter) and cross-linked (32mm and 36mm inner diameter) UHMWPE insert versions are available in the Klassic HD Hip System. Both types of UHMWPE material have been utilized in previously cleared devices. Optional 6.5mm cancellous, titanium alloy bone screws allow for additional fixation of the acetabular cup to the bone.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Klassic HD Hip System are similar to the predicate devices. Performance data were provided to support the determination of substantial equivalence.
SUBSTANTIAL EQUIVALENCE
The indications for use for the Klassic HD Hip System are substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Klassic HD Hip System is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
Extensive bench testing was conducted on the Klassic HD Hip System to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate devices. Performance testing conducted for the worst case femoral constructs addressed proximal fatigue, distal fatigue, axial disassembly and torsional disassembly. Performance testing conducted for the worst case acetabular constructs included push-out, lever-out and torque to rotation testing as well as an evaluation of wear characteristics of the insert materials. The static breaking strength and the pull-out strength of the worst case cancellous bone screw were also assessed. The porous coating was characterized per FDA's "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Opposing Bone or Bone Cement" dated April 28, 1994.
All testing was performed in accordance with recognized standards. Results confirm that all components of the Klassic HD Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement, and are substantially equivalent to the predicate devices.
SUMMARY
The Klassic HD Hip System is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring. MD 20993-0002
Total Joint Orthopedics, Inc. % Mr. Kit Cariquitan Vice President, Regulatory Affairs Regulatory Consultant for Total Joint Orthopedics, Inc. Experien Group, LLC 155-A Moffett Park Drive Suite 210 Sunnyvale, California 94089
DEC - 3 2010
Re: K100445 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, MBL, LWJ Dated: October 22, 2010 Received: October 25, 2010
Dear Mr. Cariquitan:
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.
4
Page 2 - Mr. Kit Cariquitan
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N Milken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
TOTAL JOINT ORTHOPEDICS, INC.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K100445
Device Name: Klassic HD™ Hip System
DEC. - 3. 2010
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. .
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)
Onetu for mxn
(Division Sign off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100445