IOI TOTAL HIP

K121034 · Iconacy Orthopedic Implants, LLC · LPH · Sep 4, 2012 · Orthopedic

Device Facts

• Record ID: K121034
• Device Name: IOI TOTAL HIP
• Applicant: Iconacy Orthopedic Implants, LLC
• Product Code: LPH · Orthopedic
• Decision Date: Sep 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 arthrius, 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

Device Story

Total hip prosthesis system; consists of collarless, tapered, forged titanium alloy femoral stem, cobalt chrome modular femoral head, hemispheric titanium alloy acetabular cup, and HXL-UHMWPE liner. Femoral stem features circumferential titanium coating; acetabular cup features titanium plasma spray coating for cementless, press-fit fixation. Titanium locking ring secures liner to cup. Implanted by orthopedic surgeons in clinical/OR settings using standard instrumentation. Device replaces diseased/damaged hip joint components to restore function and reduce pain. Clinical benefit derived from mechanical reconstruction of hip joint.

Clinical Evidence

No clinical data. Substantial equivalence established via nonclinical bench testing, including HXL-UHMWPE characterization, locking mechanism testing, range of motion analysis, impingement testing, wear testing, femoral head pull-off testing, and fatigue endurance limits for the femoral stem.

Technological Characteristics

Materials: Forged titanium alloy (femoral stem), cobalt chrome (femoral head), Ti-6Al-4V ELI alloy (acetabular cup), HXL-UHMWPE (liner). Surface: Titanium coating/plasma spray for cementless fixation. Design: Modular, semi-constrained, porous-coated. Fixation: Cementless, press-fit. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients with severely painful/disabled hip joints due to osteoarthritis, traumatic/rheumatoid arthritis, congenital dysplasia, avascular necrosis, acute traumatic fracture of femoral head/neck, failed prior hip surgery, ankylosis, nonunions, functional deformity, or trochanteric fractures of proximal femur requiring cementless, press-fit fixation.

Regulatory Classification

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.

Predicate Devices

• Taperloc Femoral Components (K043537)
• Taperloc Femoral Components (K921301)
• Taperloc Femoral Components (K110400)
• Regenerex Ringloc + Modular Acetabular Shell (K070369)
• ArComXL Polyethylene Liners (K042051)

Submission Summary (Full Text)

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K121034

# 3. 510(k) Summary

PREPARED:

September 3, 2012

510(k) SPONSOR:

ICONACY Orthopedic Implants, LLC PO Box 1033 Warsaw, IN 46581-1033 or 4130 Corridor Drive Warsaw, IN 46582

CONTACT PERSON:

Roy Y Hori, PhD Executive Vice President, R&D [phone] or [phone] rhori(@iconacy.com

TRADE NAME:

# ICONACY™ I-Hip™ System

Total Hip System

COMMON NAMES:

CLASSIFICATION, and CLASS:

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis ( 21 CFR Section 888.3358, Class II)

Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR Section 888.3360, Class II)

#### PRODUCT CODES: LPH, LW|

PREDICATE DEVICES:

Taperloc Femoral Components (K043537)(K921301)(K110400), Regenerex Ringloc + Modular Acetabular Shell (K070369), ArComXL Polyethylene Liners (K042051)

DEVICE DESCRIPTION: The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem, mated to a cobalt chrome modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispheric 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 and two screw holes to permit the use of screws for adjunct fixation. 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 the groove in the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.

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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 arthrius, 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 is substantially equivalent to the Taperloc and Ringloc devices in design, materials, function and indications for use.

Performance Data: Nonclinical testing was conducted to demonstrate substantial equivalency to the predicate devices including characterization of the HXL-UHMWPE, testing of the locking mechanism between the cup and liner, range of motion analysis, impingement testing, wear, femoral head pull off testing, and fatigue (endurance limits) for the femoral stem.

Clinical Testing: Clinical testing was not required for determining substantial equivalency 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 with three lines forming its body and wings. The eagle is facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ICONACY Orthopedic Implants, LLC % Roy Y. Hori, Ph.D. Executive Vice President, R&D 4130 Corridor Drive Warsaw, Indiana 46582

· SEP 4 2012

#### Re: K121034

Trade/Device Name: ICONACY™ I-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: August 23, 2012 Received: August 27, 2012

Dear Dr. Hori:

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

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Page 2 - Roy Y. Hori. Ph.D.

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eiriel Keith

~Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 2. Indications for Use

510(k) Number (if known): K121034

Device Name: ICONACYT31 I-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.
- Acute traumatic fracture of the femoral head or neck. 3.
- 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- ട്. Certain cases of ankylosis.
- Nonunions, correction of functional deformity, and trochanteric fractures of the proximal 6. 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)

Nil Q.L. Lr mxm

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K121034

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