OMNI ARC MONOBLOCK HIP STEM

K133381 · Omnilife Science · LZO · Mar 13, 2014 · Orthopedic

Device Facts

• Record ID: K133381
• Device Name: OMNI ARC MONOBLOCK HIP STEM
• Applicant: Omnilife Science
• Product Code: LZO · Orthopedic
• Decision Date: Mar 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OMNI ARC Monoblock 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 OMNI ARC Monoblock 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

OMNI ARC Monoblock Hip Stem is a curved, rectangular tapered femoral component for total hip replacement or hemiarthroplasty. Device combines neck and stem into single-piece design. Intended for uncemented fixation in primary or revision procedures. Used in conjunction with Apex Interface Acetabular System and Apex Modular Femoral Head (CoCr or ceramic) for total hip replacement, or Apex Bipolar Head for hemiarthroplasty. Implanted by orthopedic surgeons in clinical/hospital settings. Provides structural support and articulation for hip joint; restores joint function; treats degenerative disease, fractures, and deformities. Single-use device.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including fatigue strength testing per ISO 7206-6 and ISO 7206-4, and range-of-motion testing per ISO 21535.

Technological Characteristics

Curved, rectangular tapered monoblock femoral stem. Materials: titanium alloy, unalloyed titanium plasma spray, hydroxyapatite coating. Uncemented fixation. Standards: ISO 7206-6, ISO 7206-4 (fatigue), ISO 21535 (range-of-motion).

Indications for Use

Indicated for patients requiring primary or revision total hip arthroplasty or hemiarthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, congenital dislocation, or femoral neck/trochanteric fractures.

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 Hip System ARC Hip Stem (K113242)
• Apex K1 Hip Stem (K110947)

Reference Devices

• Apex Hip System ARC Hip Stem (K111193)
• Apex K1 Hip Stem (K060072)

Submission Summary (Full Text)

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| 510(K) SUMMARY | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared | November 1, 2013 |
| Manufacturer/Distributor/Sponsor | OMNIlife Science<br>50 O'Connell Way<br>Suite 10<br>East Taunton, MA 02718 |
| 510(k) Contact | Christina Flores<br>Manager, Regulatory Affairs<br>Omnilife Science<br>50 O'Connell Way<br>East Taunton, MA 02718<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | OMNI ARC Monoblock Hip Stem |
| Common Name | prosthesis, hip, semi-constrained,<br>metal/polymer, porous uncemented<br>prosthesis, hip, semi-constrained, uncemented,<br>metal/polymer, non-porous, calcium-phosphate |
| Classification Name | 21 CFR 888.3353 Hip joint<br>metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented<br>prosthesis. LZO, MEH, LPH, KWY |
| Predicate Device | K113242 - Apex Hip System ARCTM Hip Stem<br>(cleared size 0)<br>K110947 - Apex K1TM Hip Stem<br>Reference predicates:<br>K111193 Apex Hip System ARCTM Hip Stem<br>(cleared size 1-5)<br>K060072 Apex K1 Hip Stem(cleared size 2-12) |
| Purpose of Submission | This Traditional 510(k) premarket notification is<br>being submitted to obtain clearance for the<br>OMNI ARC Monoblock Hip Stem to expand<br>OMNI's product offering for total hip<br>arthroplasty. |
| 510(K) SUMMARY | |
| Device Description and intended use | The OMNI ARC Monoblock Hip Stem consists of a curved, rectangular tapered stem that combines the neck and stem into a single piece design. The OMNI ARC Monoblock 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:<br><br>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 OMNI ARC™ Monoblock Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.<br><br>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:<br><br>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. |
| 510(K) SUMMARY | |
| Substantial Equivalence Summary | The OMNI ARC Monoblock Hip Stem is<br>substantially equivalent to the predicate APEX<br>ARC Hip Stem (K113242) and the Apex K1 Hip<br>Stem (K110947) in which the fundamental<br>scientific technology and intended uses are the<br>same. Any differences between the OMNI ARC<br>Monoblock Hip Stem and the predicates are<br>considered minor and do not raise questions<br>concerning safety and effectiveness.<br><br>The proposed devices are composed of<br>titanium alloy, unalloyed titanium plasma spray,<br>with hydroxyapatite coating, the identical<br>material used in the manufacture of the<br>predicate devices.<br><br>The results of testing of the proposed ARC<br>Monoblock Hip Stems met the requirements for<br>fatigue strength per ISO 7206-6 and ISO 7206-<br>4 and the range-of-motion requirement per ISO<br>21535. These test methods are the same used<br>for the predicate devices (K110947 and<br>K113242). Based on the indications for use,<br>technological characteristics, and the<br>comparison to the predicate devices, OMNIlife<br>Science has determined that the OMNI ARC<br>Monoblock Hip Stem is substantially equivalent<br>to currently marketed predicate devices. |

K133381 Al Response March 7, 2014

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

March 13, 2014

OMNIlife Science Ms. Christina Flores Manager, Regulatory Affairs 50 O'Connell Way, Suite 10 East Taunton, Massachusetts 02718

Re: K133381

Trade/Device Name: OMNI ARC Monoblock Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH, LPH, KWY Dated: February 6, 2014 Received: February 10, 2014

Dear Ms. Flores:

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

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Page 2 - Ms. Christina Flores

(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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 vours.

## Ronald P. Jean -S for

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

Enclosure

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510(k) Number (if known): Not Known K1 3 3 3 8 1

Device Name: OMNI ARC Monoblock Hip Stem

The OMNI ARC Monoblock 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 (Coball 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; .
- י Revision procedures where other treatments or devices have failed;
- . Femoral neck and trochanteric fractures of the proximal femur.

The OMNI ARC Monoblock Hip Stem is also intended for use in hemiathroplasty 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 Prescription Use X (Part 21 CFR 801 Subpart D)

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)

RC Monoblock Hip Stem

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