(268 days)
Not Found
No
The summary describes a mechanical implant (femoral head) and its intended use and testing, with no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes
The device is described as a "prosthetic replacement" for conditions like degenerative joint disease and inflammatory joint disease, and for failed previous surgeries or total hip replacement, which are all therapeutic interventions aimed at treating a medical condition.
No
Explanation: The device is a prosthetic component (femoral head) intended for surgical replacement in hip joints, not for diagnosing medical conditions. Its purpose is to treat existing conditions, not to identify them.
No
The device description clearly states it is a physical component (femoral head) made of cobalt chromium, and the performance studies involve bench testing of physical properties like fatigue and disassembly.
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 treating various hip joint conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a modular component for a hip replacement system, made of cobalt chromium, and designed to be implanted in the hip joint. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a surgical implant used to treat existing conditions, not to diagnose them.
N/A
Intended Use / Indications for Use
The Klassic HD™ Extended Offset Femoral Head for use within 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
LPH, MBL, LWJ
Device Description
The Klassic" HD Extended Offset Femoral Head is a modular component to be used within the Klassic HD™ Hip System (K100445). The Klassic HD™ Extended Offset Femoral Head is t used within the System as an optional prosthesis to the Klassic HD™ Femoral Head, a modular femoral head used within the Klassic HD™ Hip System. The Klassic HD™ Extended Offset Femoral Head features an offset bore and is composed of cobalt chromium and available in 32mm or 36mm diameters and available in -3.5mm, neutral, +3.5mm and +7mm head lengths. The Klassic HD " Extended Offset Femoral Head is to be used within the hip joint replacement system as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing leg length and offset.
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)
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- . Fatigue Testing
- . Disassembly Testing
- . Range of Motion
- Biocompatibility .
- Sterilization and cleaning validations .
- Packaging and shelf life .
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Klassic HD" Extended Offset Femoral Head meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Klassic HD™ Extended Offset Femoral Head 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)
K100445, K103479, K033664, K914675
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
TOTAL JOINT ORTHOPEDICS, INC.
KLASSIC HD™ EXTENDED OFFSET FEMORAL HEAD 510(k) PREMARKET NOTIFICATION
510(k) SUMMARY
FEB 12 2014
510(k) Notification K131454
GENERAL INFORMATION
Applicant:
Total Joint Orthopedics, Inc. 1567 E. Stratford Avenue Salt Lake City, UT 84106 U.S.A. Phone: 801-486-6070 FAX: 801-486-6117
Contact Person:
Jean M. Wheeler Product Development Engineer Total Joint Orthopedics 1567 E. Stratford Avenue Salt-Lake City, UT 84106 U.S.A. Phone: 801-486-6070 FAX: 801-486-6117
Date 510(k) Summary Prepared: February 10, 2014
DEVICE INFORMATION
Trade Name:
Klassic HD™ Extended Offset Femoral Head
Generic/Common Name:
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Classification:
21CFR$888.3358, Class II
Product Code:
LPH, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Prosthesis MBL, prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous LWJ, prosthesis, hip, semi-constrained, metal/polymer, uncemented
1
Klassic HD™ Extended Offset Femoral Head 510(k) Premarket Notification
510(k) SUMMARY
PREDICATE DEVICE(S)
- Total Joint Orthopedics Klassic HD™ Hip System (K100445) .
- Accolade II Femoral Hip Stem, Howmedica Osteonics, Corp. (K103479) .
- Alloclassic Zweymuller SL Offset Femoral Stem, Centerpulse Orthopedics (K033664) .
- Modular Femoral Head with Offset Trunion, Kirschner Medical Corp (K914675) .
INDICATIONS FOR USE
The Klassic HD™ Extended Offset Femoral Head for use within 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 Extended Offset Femoral Head is a modular component to be used within the
Klassic HD™ Hip System (K100445). The Klassic HD™ Extended Offset Femoral Head is t used within the System as an optional prosthesis to the Klassic HD™ Femoral Head, a modular femoral head used within the Klassic HD™ Hip System. The Klassic HD™ Extended Offset Femoral Head features an offset bore and is composed of cobalt chromium and available in 32mm or 36mm diameters and available in -3.5mm, neutral, +3.5mm and +7mm head lengths. The Klassic HD " Extended Offset Femoral Head is to be used within the hip joint replacement system as a prosthesis designed to help surgeons restore hip joint biomechanics intraoperatively by independently addressing leg length and offset.
2
Klassic HD™ Extended Offset Femoral Head 510(k) PREMARKET NOTIFICATION
510(k) SUMMARY
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Klassic HD™ Extended Offset Femoral Head are similar to the predicate devices in material, design and function. The Klassic HD" Extended Offset Femoral Head assembled with a modular femoral stem functions as a femoral component intended for total hip replacement. The device utilizes a functional neck and lateral offset which is substantially equivalent to the end geometry achieved by the modular femoral components of predicate devices. Performance data for fatigue testing of the assembled femoral component, modular disassembly properties and range of motion were provided to support the determination of substantial equivalence.
SUBSTANTIAL EQUIVALENCE
The proposed indications for use for the Klassic HD™ Extended Offset Femoral Head 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" Extended Offset Femoral Head is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench testing was conducted on the Klassic HD" Extended Offset Femoral Head to support a determination of substantial equivalence to the predicate devices.
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- . Fatigue Testing
- . Disassembly Testing
- . Range of Motion
- Biocompatibility .
- Sterilization and cleaning validations .
- Packaging and shelf life .
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Klassic HD" Extended Offset Femoral Head meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Klassic HD™ Extended Offset Femoral
3
TOTAL JOINT ORTHOPEDICS, INC.
Klassic HD™ Extended Offset Femoral Head 510(k) PREMARKET NOTIFICATION
510(k) SUMMARY
Head does not raise new questions of safety or effectiveness for total hip joint replacement when compared to the predicate devices.
CONCLUSION
The results of the non-clinical testing verify that the Klassic HD™ Extended Offset Femoral Head functions as intended and exhibits the appropriate characteristics for total hip joint replacement. The Klassic HD™ Extended Offset Femoral Head has the same intended use and similar technological characteristics as those of the predicate devices. Furthermore, device safety and performance testing have demonstrated that the device performs as intended in its intended use environment. As such, the Klassic HD™ Extended Offset Femoral Head is substantially equivalent to the predicate devices in terms of technological characteristics, intended use and performance.
SUMMARY
The Klassic HD Extended Offset Femoral Head is substantially equivalent to the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2014
Total Joint Orthopedics, Incorporated Ms. Jean Marie Wheeler Product Development Engineer 1567 East Stratford Avenue Salt Lake City, Utah 84106
Re: K131454
Trade/Device Name: Klassic HDTM Extended Offset Femoral Head 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: January 10, 2014 Received: January 13, 2014
Dear Ms. Wheeler:
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
5
and and a more of the bear Page 2 - Ms. Jean Marie Wheeler
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/ReportalProblem/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,
Lori A. Wiggins
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™ Extended Offset Femoral Head 510(k) Premarket Notification
SECTION 4
: '
Indications for Use Statement
510(k) Number (if known): K131454
Device Name: Klassic HD™ Extended Offset Femoral Head
Indications For Use:
The Klassic HD " Extended Offset Femoral Head, for use within 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)
ElizabethFDFrank-S
Divison of Orthopedic Devices