APEX ARC HIP STEM

K113242 · Omni Life Science, Inc. · LPH · Jan 5, 2012 · Orthopedic

Device Facts

• Record ID: K113242
• Device Name: APEX ARC HIP STEM
• Applicant: Omni Life Science, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Jan 5, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex ARC™ Hip Stem is intended for use as the femoral component of a primary, or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate: • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; • Rheumatoid arthritis; • Correction of functional deformity; • Congenital dislocation; • Revision procedures where other treatments or devices have failed; • Femoral neck and trochanteric fractures of the proximal femur. The Apex Hip System ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: • Femoral neck and trochanteric fractures of the proximal femur; • Osteonecrosis of the femoral head; • Revision procedures where other treatments or devices for these indications have failed.

Device Story

Apex ARC Hip Stem is a curved, rectangular tapered femoral component for total hip arthroplasty or hemiarthroplasty; features distal slot and modular neck connection. Subject device is Size 0, which lacks the lateral t-flange found on larger sizes. Manufactured from titanium alloy; modular necks from cobalt chromium alloy. Used in clinical settings by orthopedic surgeons; implanted via uncemented fixation. Provides structural support for hip joint; articulates with Apex Interface Acetabular System or Apex Bipolar Head. Benefits patients by restoring joint function and addressing degenerative disease or fractures.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing only, including fatigue strength testing per ISO 7206-6, ISO 7206-4, ISO 7206-8, and ASTM 2068-09, and range-of-motion (ROM) evaluation per ISO 21535.

Technological Characteristics

Femoral stem: titanium alloy. Modular necks: cobalt chromium alloy. Design: curved, rectangular tapered stem with distal slot. Available with/without HA coating. Testing standards: ISO 7206-4/6/8, ASTM 2068-09 (fatigue), ISO 21535 (ROM). Uncemented fixation.

Indications for Use

Indicated for patients requiring primary or revision total hip replacement or hemiarthroplasty. Conditions include non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, congenital dislocation, femoral neck/trochanteric fractures, and osteonecrosis. Intended for uncemented 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

• Apex ARC Hip Stem (K090845)
• Apex ARC Hip Stem (K111193)

Submission Summary (Full Text)

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:

Apex ARC ™ Hip Stem

7 December, 2011

| Submitter | OMNIlife science, Inc.<br>50 O'Connell Way<br>E. Taunton MA 02718 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Christine Nassif<br>Director, Regulatory Affairs<br>774-226-1871<br>[phone] (fax) |
| Preparation Date | 7 December, 2011 |
| Device Name | Apex Hip System |
| Trade Name | Apex ARC ™ Hip Stem |
| Sizes | Apex ARC Hip Stem, Size O<br>Apex ARC Hip Stem, Size 0 HA Coated |
| Common name/Classification | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis<br>Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
| Regulatory Class | Class II per 21 CFR § 888.3358, §888.3353, § 888.3390 |
| Product Code | LPH, LZO, MEH, KWY |
| Legally Marketed Predicate Device(s) | Apex ARC Hip Stem (K090845), Apex ARC Hip Stem (K111193) |
| Device Description | The Apex ARC Hip Stem consists of a curved, rectangular tapered stem with a distal slot, and modular necks that connect to the tapered hole in the stem. The larger size stems have a lateral feature referred to as a lateral t-flange. The T-flange is reduced in size on the smaller stem sizes (size 1 and 2), and further reduced to no t-flange on the smallest (subject) size 0 stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. The Apex ARC Hip Stem is available with and without HA coating.<br><br>The necks are compatible with the Cobalt Chromium and Ceramic modular heads, and may be used with head diameters and offsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunction with the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty. |

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| Indications for<br>Use | The Apex ARC™ Hip Stem is intended for use as the femoral component of a<br>primary, or revision total hip replacement when used with the Apex Interface™<br>Acetabular System. The Apex Interface™ Acetabular System articulates with the<br>Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem<br>is intended for uncemented fixation and single use implantation. These prostheses<br>may be used for hip arthroplasty to treat the following conditions, as appropriate:<br><br>• Non-inflammatory degenerative joint disease, including osteoarthritis and<br>avascular necrosis;<br>• Rheumatoid arthritis;<br>• Correction of functional deformity;<br>• Congenital dislocation;<br>• Revision procedures where other treatments or devices have failed;<br>• Femoral neck and trochanteric fractures of the proximal femur. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Apex Hip System ARC™ Hip Stem is also intended for use in hemiarthroplasty<br>when used with the Apex Bipolar Head. |
| | The Apex Hip System Bipolar Head is intended for use in combination with an Apex<br>Hip System femoral stem for uncemented primary or revision hemiarthroplasty of<br>the hip. This prosthesis may be used for the following conditions, as appropriate:<br><br>• Femoral neck and trochanteric fractures of the proximal femur;<br>• Osteonecrosis of the femoral head;<br>• Revision procedures where other treatments or devices for these indications have<br>failed. |
| Predicate Device<br>Comparison | The Apex ARC Hip Stem is manufactured, packaged, and sterilized using equivalent materials<br>and processes. The subject device(s) is also substantially equivalent to its predicate(s) based<br>on comparison of design features, intended use, and indications for use. The fundamental<br>scientific technology of the modified device(s) has not changed relative to the predicate<br>device(s). The safety and effectiveness of the devices has not changed relative to the<br>predicate devices. The safety and effectiveness of the Apex ARC Hip Stem is adequately<br>supported by the substantial equivalence information, materials information, and analysis<br>data provided within this Premarket Notification. |
| Non-Clinical Test<br>Summary | The following tests were conducted:<br>• Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09<br>• ROM Evaluation per ISO 21535 |
| Clinical Test<br>Summary | No clinical studies were performed. |
| Conclusions | The addition of one new stem size for the Apex ARC Hip Stem, in our opinion, is substantially<br>equivalent to the predicate device. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle with its wings spread.

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

OMNIlife Science Inc. % Ms. Christine Nassif 50 O'Connell Way East Taunton, MA 02718 US

JAN - 5 2012

Re: K113242

Trade/Device Name: Apex ARC Hip Stem 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, LZO, MEH, KWY Dated: December 7, 2011 Received: December 8, 2011

Dear Ms. Christine Nassif:

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 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.

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Page 2 - Ms. Christine Nassif

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/ResourcesforYou/Industry/default.htm.

Sincerely yours!

Mark N. Mellon

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

Enclosure

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# ્રીડિટનડ

# Indications for Use

# 510(k) Number (if known):

# Device Name: Apex ARC Hip System

The Apex ARC™ Hip Stem is intended for use as the femoral component of a primary, or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobait Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate:

- · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity;
- · Congenital dislocation;
- · Revision procedures where other treatments or devices have failed;
- · Femoral neck and trochanteric fractures of the proximal femur.

The Apex Hip System ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiathroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

- · Femoral neck and trochanteric fractures of the proximal femur;
- · Osteonecrosis of the femoral head;
- · Revision procedures where other treatments or devices for these indications have failed.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

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*(Division Sign-Off)*

Division of surgical, Orthopedic, and Restorative Devices

**510(k) Number** K113242
Special 510(k) Apec ARC Hip Stem-Size 0

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