(88 days)
No
The summary describes a mechanical hip implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device, the ICONACY I-Hip System, is indicated for conditions such as severe hip pain, arthritis, avascular necrosis, and failed hip surgeries, aiming to alleviate symptoms and restore function. This direct health benefit indicates it is a therapeutic device.
No
The device is a total hip replacement system, indicated for treating various hip joint conditions by replacing damaged components. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components made of titanium alloy, cobalt chrome alloy, and polyethylene, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ICONACY I-Hip System is a total hip replacement system consisting of implants (femoral stem, acetabular cup, etc.) designed to be surgically implanted into the human body to replace a damaged hip joint. Its intended use is to treat various conditions affecting the hip joint.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any specimens taken from the body. The device is a physical implant.
Therefore, the ICONACY I-Hip System falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ICONACY I-Hip System is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The ICONACY I-Hip System consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.
Product codes
LPH, LWJ
Device Description
The ICONACY I-Hip System consists of a collarless, tapered, forged titanium alloy femoral stem mated to a cobalt chrome alloy modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispherical titanium alloy cup (i.e., shell) coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty . percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into grooves on the cup to engage grooves on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.
The current submission adds stems with additional offsets to the I-Hip System. Compatible femoral heads, acetabular cups, acetabular liners, locking rings and bone screws were cleared in K121034 and K131279.
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)
Proximal and distal stem fatigue testing were performed according to ISO 7206-6 and ISO 7206-4 to confirm that the 1-Hip GT Femoral Stems met pre-determined criteria for neck fatigue and distal stem fatigue strength. A range of motion analysis was also conducted to confirm that the I-Hip GT Femoral Stems do not create a new worst case compared to the original I-Hip Femoral Stems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
JAN 17 2014
K133228 Page 1 of 2
| 510(k) Summary | |
|---|---|
| PREPARED: | October 16, 2013 |
| 510(k) SPONSOR: | ICONACY Orthopedic Implants, I.I.C. |
| 4130 Corridor Drive | |
| Warsaw, IN 46582 | |
| CONTACT PERSON: | Marc E. Ruhling |
| Vice President, Product Development | |
| (574) 269-4266 or (574) 549-7710 | |
| FAX: (866) 685-8226 | |
| MRuhling@iconacy.com | |
| TRADE NAME: | ICONACYTM I-Hip™ System, Gradual Transitioning |
| (GTTM) Femoral Stems | |
| COMMON NAMES: | Total Hip System |
| CLASSIFICATION | |
| and CLASS: | I-lip joint metal/polymer/metal semi-constrained porous- |
| coated uncemented prosthesis (21 CFR Section 888.3358, | |
| Class II) | |
| PRODUCT CODES: | LPH, LWJ |
| PREDICATE DEVICE: | ICONACY I-Hip Total Hip System, K121034 |
| DEVICE DESCRIPTION: The ICONACY I-Hip System consists of a collarless, | |
| tapered, forged titanium alloy femoral stem mated to a cobalt chrome alloy modular femoral | |
| head. This femoral construct articulates with an acetabular device assembly. The acetabular | |
| device assembly consists of a hemispherical titanium alloy cup (i.e., shell) coupled with a |
highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty . percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into grooves on the cup to engage grooves on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.
1
The current submission adds stems with additional offsets to the I-Hip System. Compatible femoral heads, acetabular cups, acetabular liners, locking rings and bone screws were cleared in K121034 and K131279.
INDICATIONS FOR USE: The ICONACY I-Hip System is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The ICONACY I-Hip System consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.
BASIS FOR SUBSTANTIAL EQUIVALENCE: The ICONACY I-Hip GT Femoral Stems are substantially equivalent to the stems cleared in K121034 based on similarities in design, materials, function and indications for use.
PERFORMANCE DATA: Proximal and distal stem fatigue testing were performed according to ISO 7206-6 and ISO 7206-4 to confirm that the 1-Hip GT Femoral Stems met pre-determined criteria for neck fatigue and distal stem fatigue strength. A range of motion analysis was also conducted to confirm that the I-Hip GT Femoral Stems do not create a new worst case compared to the original I-Hip Femoral Stems.
CLINICAL TESTING: Clinical testing was not required for determining substantial equivalence with the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three distinct, curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2014
ICONACY Orthopedic Implants, LLC Mr. Marc E. Ruhling Vice President, Product Development 4130 Corridor Drive Warsaw, Indiana 46582
Re: K133228 Trade/Device Name: ICONACY™ I-Hip™ Total 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, LWJ Dated: December 20, 2013 Received: December 23, 2013
Dear Mr. Ruhling:
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
3
Page 2 - Mr. Marc E. Ruhling
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" (21 CFR 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.
Ronald#@Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K13 3 2 2 8
Device Name: ICONACY™ I-Hip™ Total Hip System
Indications for Use:
The ICONACY I-Hip System is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The ICONACY I-Hip System consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
ElizabethFrank-S
Division of Orthopedic Devices