(95 days)
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.
The ICONACY I-Hip 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 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 a groove on the cup to engage a groove on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.
The current submission is for modifications to the acetabular cups and locking rings cleared in K121034, and the addition of spiked and finned acetabular cups in the same sizes and materials as those cleared in K120134. The compatible femoral heads, acetabular liners and bone screws are unchanged from those cleared in K121034.
Here's a breakdown of the acceptance criteria and the study information for the ICONACY™ I-Hip™ System, based on the provided document:
This 510(k) submission (K131279) is for modifications to existing components and the addition of new acetabular cups, not for an entirely new device. Therefore, the "study" described focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical trial for novel device performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Results) |
|---|---|
| Mechanical Performance of Modified Designs | |
| Push-out testing (of modified acetabular cups/locking rings) | Performed, and results contributed to a determination of substantial equivalence (specific numerical values are not provided in this summary document). |
| Lever-out testing (of modified acetabular cups/locking rings) | Performed, and results contributed to a determination of substantial equivalence (specific numerical values are not provided in this summary document). |
| Torque-out testing (of modified acetabular cups/locking rings) | Performed, and results contributed to a determination of substantial equivalence (specific numerical values are not provided in this summary document). |
| Equivalence to Predicate Device (K121034) | |
| Similarity in design | Demonstrated to be similar. |
| Similarity in materials | Demonstrated to be similar. |
| Similarity in function | Demonstrated to be similar. |
| Similarity in indications for use | Demonstrated to be similar. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a traditional clinical study with patient samples. The performance data is derived from in vitro mechanical testing of the device components.
- Sample Size for Mechanical Testing: Not explicitly stated (e.g., number of cups tested, number of forces applied).
- Data Provenance: This is an in vitro engineering study, not human or animal data. The origin would be the testing facility of ICONACY Orthopedic Implants, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this type of submission is based on engineering principles and established mechanical testing protocols. There is no mention of external human experts establishing a ground truth for the in vitro test results in this 510(k) summary.
4. Adjudication Method for the Test Set
Not applicable, as this was an in vitro mechanical testing study, not a clinical study requiring adjudication of patient outcomes or imaging interpretations. The determination of "substantial equivalence" based on these tests would be made internally by the sponsor and reviewed by the FDA.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a study involving AI, human readers, or medical imaging. It is a submission for an orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission's performance data is based on mechanical testing standards and engineering specifications designed to ensure the modified components are as robust and perform similarly to the predicate device. The goal is to demonstrate that the physical properties and performance under stress (push-out, lever-out, torque-out) meet acceptable thresholds for orthopedic implants of this type and are comparable to the previously cleared predicate.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this 510(k) submission, as it does not involve machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device submission.
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K131279 page 1/2
| 510(k) Summary | |
|---|---|
| PREPARED: | May 3, 2013 |
| 510(k) SPONSOR: | ICONACY Orthopedic Implants, LLC4130 Corridor DriveWarsaw, IN 46582 |
| CONTACT PERSON: | AUG 0 9 201Marc E. RuhlingDirector of Development, Hips & Shoulders(574) 269-4266 or (574) 549-7710FAX: (866) 685-8226MRuhling@iconacy.com |
| TRADE NAME: | ICONACY™ I-Hip™ System |
| COMMON NAMES: | Total Hip System |
| CLASSIFICATIONand CLASS: | Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis ( 21 CFR Section 888.3358, Class II) |
| PRODUCT CODE: | LPH |
| PREDICATE DEVICE: | ICONACY I-Hip Total Hip System, K121034 |
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. 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. 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 a groove on the cup to engage a groove on the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.
The current submission is for modifications to the acetabular cups and locking rings cleared in K121034, and the addition of spiked and finned acetabular cups in the same sizes and materials as those cleared in K120134. The compatible femoral heads, acetabular liners and bone screws are unchanged from those cleared in K121034.
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K131279 Page 2/2
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 modified and additional components of the ICONACY I-Hip Total Hip System are substantially equivalent to the acetabular cups and locking rings cleared in K121034 based on similarities in design, materials, function and indications for use.
PERFORMANCE DATA: The described modifications are not expected to affect the performance of the I-Hip Total Hip System. A risk analysis of the modifications was completed and push-out, lever-out and torque-out testing of the modified designs was performed. Based on similarities in design, sizes, materials, functions for use and the results of this testing, the modified designs were determined to be substantially equivalent to the previous designs.
CLINICAL TESTING: Clinical testing was not required for determining substantial equivalence with the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2013
Mr. Marc E. Ruhling Director of Development, Hips & Shoulders ICONACY Orthopedic Implants, LLC. 4130 Corridor Drive Warsaw, Indiana 46582
Re: K131279
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 Dated: June 25, 2013 Received: June 26, 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
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Page 2 - Mr. Marc E. Ruhling
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/8 description: The image shows the name "Erin Keith" in a stylized font. The letters "Erin" are in a bold, sans-serif font, while the letters "I.D. Keith" are in a more decorative font. The letters "I.D." are filled with a pattern of lines and dots, and the letter "K" is also decorated with lines.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __ K131279
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)
7
Elizabeth L. Erank -S
Page 1 of 1
Division of Orthopedic Devices
§ 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.