APEX ARC HIP STEM

K111193 · Omni Life Science, Inc. · LZO · Jun 27, 2011 · Orthopedic

Device Facts

• Record ID: K111193
• Device Name: APEX ARC HIP STEM
• Applicant: Omni Life Science, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Jun 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• 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 femoral component for total hip arthroplasty or hemiarthroplasty; features curved, rectangular tapered stem with modular necks. Subject device introduces three new neck sizes (Long Neutral, Long 8° Varus/Valgus, Anteverted) and reduced height of anterior/posterior lateral T-flange on sizes 1 and 2. Device implanted by orthopedic surgeons in clinical/hospital settings. Provides structural support for hip joint; articulates with modular heads (CoCr or Ceramic) and acetabular systems. Benefits patients by restoring joint function and addressing degenerative conditions or fractures. Design changes intended to improve fit and surgical options.

Clinical Evidence

No clinical studies were performed. Substantial equivalence supported by bench testing, including fatigue strength testing per ISO 7206-6, ISO 7206-4, ISO 7206-8, and ASTM 2068-09, and ROM evaluation per ISO 21535.

Technological Characteristics

Materials: Ti6Al4V (ASTM F136), unalloyed titanium plasma spray (ASTM F1580), hydroxyapatite plasma spray (ASTM F1185), CoCr alloy (ASTM F1537). Design: Curved, rectangular tapered stem with modular necks. Sterilization: Ethylene oxide (SAL 10^-6).

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 of the femoral head. Intended for uncemented fixation.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Apex ARC™ Hip Stem (K090845)

Submission Summary (Full Text)

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JUN 2 7 2011

# 510(k) Summary

| Apex Hip System ARC ™ Hip Stem | | | | 01June 2011 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------------------------------------------------------------------------|-------------|
| Submitter | OMNIlife science, Inc.<br>50 O'Connell Way<br>E. Taunton MA 02718 | Contact | Radhika Pondicherry<br>Regulatory Affairs<br>774-226-1852<br>[phone] (fax) | |
| Preparation Date | 01 June, 2011 | | | |
| Device Name<br>Trade Name | Apex Hip System<br>Apex ARC ™ Hip Stem, | | | |
| Sizes | Apex ARC Hip Stem, Size 1<br>Apex ARC Hip Stem, Size 1 HA Coated<br>Apex ARC Hip Stem, Size 2<br>Apex ARC Hip Stem, Size 2 HA Coated<br>Apex ARC Hip System Modular Neck, Anteverted<br>Apex ARC Hip System Modular Neck, Long Neutral<br>Apex ARC Hip System Modular Neck, Long 8° Varus/Valgus | | | |
| Common name/<br>Classification | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis<br>Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented<br>prosthesis<br>Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. | | | |
| Regulatory Class<br>Product Code | Class II per 21 CFR § 888.3358, §888.3353, §888.3390<br>21 CFR Product Code- LPH, LZO, MEH, KWY | | | |
| Legally Marketed<br>Predicate Device(s) | K090845- Apex ARC™ Hip Stem | | | |
| Device Description | The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that<br>connect to the tapered hole in the stem. The height of the anterior and posterior lateral<br>protrusions (Lateral T-Flange) was reduced on Size 1 and 2 ARC Hip Stems. Three new neck sizes<br>are offered, Long Neutral, Long 8 ° Varus/Valgus and Anteverted. The necks are compatible with<br>the Cobalt Chromium and Ceramic modular heads, and may be used with head diameters and<br>offsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunction<br>with the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty. | | | |

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K111193/(Page 2 of 3)

#### Indications for 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.

| | Apex ARC Hip Stem,<br>Additional necks and<br>Lateral T-Flange stem<br>design change<br>(subject device) | Apex ARC Hip Stem<br>(K090845) |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Intended Use | | |
| Primary and revision total hip<br>replacement | Yes | Yes |
| Design | | |
| T-Flange | T-Flange was reduced by<br>half on the size 1 and size 2<br>ARC Hip Stem. | ARC Hip Stem T-flange<br>size 1 and size 2 |
| Stem Design | Curved, rectangular tapered<br>stem. | Curved, rectangular<br>tapered stem. |
| Neck Design | Long neutral, long 8 °<br>varus/valgus, anteverted | Neutral, 8° and 12 °<br>varus/valgus |
| Materials | | |
| Apex ARC Hip Stem | Identical to K090845 | Ti6Al4V<br>per ASTM F136 |
| Plasma spray Titanium<br>coating | Identical to K090845 | Unalloyed titanium<br>plasma spray<br>per ASTM F1580 |
| Hydroxyapatite Coating | Identical to K090845 | Hydroxyapatite plasma<br>spray coating<br>per ASTM F1185 |
| Apex ARC Modular Neck | Identical to K090845 | CoCr alloy |

# Predicate Device Comparison

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K1111193 (pg. 3 of 3)

| | | | per ASTM F1537 |
|---------------|----------------------|----------------------------------------------|----------------|
| PACKAGING | AND | | |
| STERILIZATION | | | |
| Sterilization | Identical to K090845 | Ethylene oxide | |
| SAL | Identical to K090845 | $10^{-6}$ | |
| Packaging | Identical to K090845 | Paper Board Box, Double<br>Tyvek inner pouch | |

Non-Clinical Test

The following tests were conducted:

Summary

The following tests were conducted

- t Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09
- . ROM evaluation per ISO 21535

Clinical Test No clinical studies were performed. Summary

- The addition of 3 new neck options; Long Neutral, Long 8 ° Varus/Valgus and Anteverted, and the Conclusions reduction of height of the anterior and posterior lateral protrusions (Lateral T-Flange) for the Size 1 and 2 ARC Hip Stems described in this submission are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

OMNIlife Science, Inc. % Ms. Radhika Pondicherry Regulatory Affairs 50 O'Connell Way East Taunton, Massachusetts 02718

JUN 2 7 2011

Re: K111193 Trade/Device Name: Apex ARCTM Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: Class II Product Code: LZO, MEH, LPH, KWY Dated: June 1, 2011 Received: June 2, 2011

Dear Ms. Pondicherry:

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.

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 – Ms. Radhika Pondicherry

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 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,

Eunel Keith

For 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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# Indications for Use

# 510(k) Number: K111193

# Device Name: Apex Hip System 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 (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.

AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (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)

Page 1 of 1

for M.Meikerson

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

510(k) Number K111193