(66 days)
No
The document describes a mechanical hip implant system and does not mention any software, algorithms, or AI/ML components.
Yes
The device is a total hip replacement system, used to alleviate pain and disability in the hip joint due to various conditions, which directly indicates a therapeutic purpose.
No
This device is a total hip replacement system, used to treat painful and/or disabled hip joints. It is an implantable medical device designed for treatment, not for diagnosing conditions.
No
The device description clearly outlines physical components made of titanium and cobalt chrome alloys, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- ICONACY I-Hip Function: The ICONACY I-Hip is a total hip replacement system. It is an implantable device used to replace a damaged hip joint within the human body.
- Intended Use: The intended use clearly describes treating conditions of the hip joint through surgical implantation.
- Device Description: The description details the physical components of the implant (femoral stem, acetabular cup, etc.) and how they are designed for surgical fixation.
The ICONACY I-Hip is a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The ICONACY I-Hip 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 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 consists of a collarless, tapered, forged titanium alloy femoral stem mated to a cobalt chrome alloy modular femoral head. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. This femoral construct articulates with an acetabular device assembly.
The acetabular device assembly consists of a hemispherical titanium alloy cup coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy and is available in standard, finned and spike configurations. The acetabular cup has a threaded polar hole for insertion. The standard and finned cups have screw holes for additional fixation.
The outer hemispheric surface of the acetabular cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into a groove on the cup to engage a groove on the HXLUHMWPE liner. Standard instrumentation is used to implant the device.
The current submission addresses modifying the standard and finned acetabular cups to add a third screw hole. The acetabular cup materials, porous coating and indication for use remain the same. No additional sizes are being added to the product line. No new instruments are required. The spiked cups are unchanged with no screw holes.
The compatible femoral stems, femoral heads, acetabular liners and bone screws remain unchanged from those cleared under K121034.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, femoral head, femoral neck, proximal femur
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
Finite Element Analysis (FEA) confirmed that adding a third screw hole to the acetabular cups had little impact on cup stiffness.
Key Metrics
Not Found
Predicate Device(s)
ICONACYTM I-Hip™ Total Hip System, K121034, ICONACY™ I-Hip™ Total Hip System, K131279
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.
April 8, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Iconacy Orthopedic Implants, LLC % Ms. Carol Vierling President C L Vierling, LLC 3560 Greystone Drive Warsaw, Indiana 46582
Re: K160266 Trade/Device Name: ICONACYTM I-Hip™ 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 Dated: March 23, 2016 Received: March 24, 2016
Dear Ms. Vierling:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160266
Device Name ICONACYTM I-Hip™
Indications for Use (Describe)
The ICONACY I-Hip 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 consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor; and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 RE
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
I. SUBMITTER
ICONACY Orthopedic Implants, LLC 4130 Corridor Drive Warsaw, IN 46582
| Contact Person: | Thomas R. Allen |
|---|---|
| Telephone Number: | (574) 453-6567 |
| Fax Number: | (866) 685-8226 |
- II. DEVICE
Date Prepared:
| Proprietary Name: | ICONACY™ I-Hip™ |
|---|---|
| Common Name: | Total Hip System |
| Regulation: | 21 CFR 888.3358, Hip joint metal/polymer/metal semi- |
| constrained porous-coated uncemented prosthesis | |
| Class: | II |
| Panel: | Orthopedics |
| Product Code: | LPH |
March 17, 2016
PREDICATE DEVICES III.
ICONACYTM I-Hip™ Total Hip System, K121034 ICONACY™ I-Hip™ Total Hip System, K131279
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
- IV. DEVICE DESCRIPTION
The ICONACY I-Hip consists of a collarless, tapered, forged titanium allov femoral stem mated to a cobalt chrome alloy modular femoral head. Forty percent of the femoral stem is circumferentially coated with a titanium coating
4
designed to attain a cementless, press-fit fixation. This femoral construct articulates with an acetabular device assembly.
The acetabular device assembly consists of a hemispherical titanium alloy cup coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy and is available in standard, finned and spike configurations. The acetabular cup has a threaded polar hole for insertion. The standard and finned cups have screw holes for additional fixation.
The outer hemispheric surface of the acetabular cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into a groove on the cup to engage a groove on the HXLUHMWPE liner. Standard instrumentation is used to implant the device.
The current submission addresses modifying the standard and finned acetabular cups to add a third screw hole. The acetabular cup materials, porous coating and indication for use remain the same. No additional sizes are being added to the product line. No new instruments are required. The spiked cups are unchanged with no screw holes.
The compatible femoral stems, femoral heads, acetabular liners and bone screws remain unchanged from those cleared under K121034.
V. INDICATION FOR USE
The ICONACY I-Hip 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 consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.
No changes are being made to the indication for use.
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The original ICONACY I-Hip was cleared under K121034. The acetabular cups described in that submission had two screw holes for additional fixation (standard acetabular cups). Under K131279, spiked and finned cups were added to the I-Hip System (in the same sizes as those described in K121034), again with two screw holes for additional fixation. The modification that is the subject of this 510(k) is the addition of a third screw hole to the standard and finned acetabular cups. The spiked acetabular cups remain with no screw holes.
The acetabular cup materials, porous coating and indication for use remain the same. No additional sizes are being added to the product line. No new instruments are required. The compatible femoral stems, femoral heads, acetabular liners and bone screws remain unchanged from those cleared under K121034.
VII. PERFORMANCE DATA
Finite Element Analysis (FEA) confirmed that adding a third screw hole to the acetabular cups had little impact on cup stiffness.
Clinical testing was not required to establish equivalency of the device.
VIII. CONCLUSIONS
The modified acetabular cups utilize the same fundamental scientific technology, are made of the same materials, mate with the same femoral components and bone screws and have the same indication for use as the predicate standard and finned acetabular cups of the ICONACY I-Hip. The non-clinical testing demonstrates that adding a third screw hole does not raise any new questions of safety or effectiveness. Therefore, the modified acetabular cups of the ICONACY I-HIP are substantially equivalent to the predicate devices.