(225 days)
No
The description focuses on the materials, design, and mechanical aspects of the hip implant system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a total hip replacement system intended to alleviate severe pain and disability caused by various hip joint conditions. By replacing the damaged joint, it aims to restore function and reduce symptoms, which is a therapeutic purpose.
No
The device is a hip implant system intended for surgical replacement of a hip joint due to various conditions, not for diagnosing them.
No
The device description clearly outlines physical components made of titanium alloy, cobalt chrome alloy, and polyethylene, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a hip replacement system (femoral stem, acetabular cup, liners, etc.). These are physical implants used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
- Performance Studies: The performance studies mentioned relate to range of motion and material properties, which are relevant to the function of a surgical implant, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ICONACY I-Hip System does not fit this definition.
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, rheumatoid 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
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 ultrahigh 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-UHMVPE liner. Standard instrumentation is used to implant the device.
The current submission adds angled face, lateralized and extended wall acetabular liners and an apex hole plug to the I-Hip Total Hip System. The compatible femoral heads, acetabular cups, locking rings and bone screws were cleared in K121034. Additional compatible acctabular cups and locking rings were cleared in 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)
Range of motion analyses were completed for the acetabular liners to ensure that adequate range of motion was maintained. Characterization and biocompatibility data for color additives is provided in a Master File, which is referenced in the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ICONACY I-Hip Total Hip System, K121034
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.
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K132572 page 1 of 2
| 510(k) Summary | |
|---|---|
| PREPARED: | September 10, 2013 |
| 510(k) SPONSOR: | ICONACY Orthopedic Implants, LLC |
| 4130 Corridor Drive | |
| Warsaw, IN 46582 | |
| CONTACT PERSON: | Marc E. Ruhling |
| Director of Development, Hips & Shoulders | |
| (574) 269-4266 or (574) 549-7710 | |
| FAX: (866) 685-8226 | |
| MRuhling@iconacy.com | |
| TRADE NAME: | ICONACY™ I-Hip™ System |
| COMMON NAMES: | Total Hip System |
| CLASSIFICATION | |
| and CLASS: | Hip joint metal/polymer/metal semi-constrained porous-coated |
| uncemented prosthesis ( 21 CFR Section 888.3358, Class II) | |
| PRODUCT CODES: | LPH |
| 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 ultrahigh 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-UHMVPE liner. Standard instrumentation is used to implant the device.
The current submission adds angled face, lateralized and extended wall acetabular liners and an apex hole plug to the I-Hip Total Hip System. The compatible femoral heads, acetabular
1
cups, locking rings and bone screws were cleared in K121034. Additional compatible acctabular cups and locking rings were cleared in 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 acerabular cup (i.e. shill) porous coated components intended for cementless, press-fit fixation.
BASIS FOR SUBSTANTIAL EQUIVALENCE: The additional components of the ICONACY I-Hip Total Hip System are substantially equivalent to the components cleared in K121034 based on similarities in design, materials, function and indications for use.
PERFORMANCE DATA: Range of motion analyses were completed for the acetabular liners to ensure that adequate range of motion was maintained. Characterization and biocompatibility data for color additives is provided in a Master File, which is referenced in the submission.
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 Department of Health & Human Services, USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2014
Iconacy Orthopedic Implants, LLC Mr. Marc E. Ruhling Director of Development. Hips & Shoulders 4130 Corridor Drive Warsaw, Indiana 46582
Re: K132572
Trade/Device Name: Iconacy I-Hip Total Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/mctal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: February 14. 2014 Received: February 18, 2014
Dear Mr. Ruhling:
We have reviewed your Scction 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 10 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 adultcration. Please note: CDRFI 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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse cvents) (21 CFR 803); good manufacturing practice requirements as sct
3
Page 2 - Mr. Marc E. Ruhling
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiqqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K132572 page 1 of 1
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
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, rheumatoid 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)
Over-The-Counter Use AND/OR (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)
Elizabet顾莎rank -S
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Division of Orthopedic Devices