OMNI Anseris Hip Stem

K171156 · Omnilife Science · LZO · Aug 17, 2017 · Orthopedic

Device Facts

• Record ID: K171156
• Device Name: OMNI Anseris Hip Stem
• Applicant: Omnilife Science
• Product Code: LZO · Orthopedic
• Decision Date: Aug 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OMNI Anseris 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 Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

Device Story

OMNI Anseris Hip Stem is a tapered, 'fit and fill' femoral component for total hip arthroplasty or hemiarthroplasty; intended for uncemented fixation. Device functions as a structural implant replacing the femoral head/neck; used in surgical settings by orthopedic surgeons. Input is the patient's prepared femoral canal; device provides mechanical support and articulation interface for femoral heads (Apex Modular or Bipolar). Benefits include restoration of hip joint function and stability. Unlike modular predicate stems, Anseris features an integral neck and trunnion design. Clinical decision-making relies on surgeon assessment of patient anatomy and pathology.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included fatigue strength (ISO 7206-4/6), range-of-motion analysis (ISO 21535), FEA (ASTM F2996-13), and impingement risk assessment.

Technological Characteristics

Titanium alloy with unalloyed titanium plasma spray. Tapered conical 'fit and fill' design with integral neck and trunnion. Sterilization via ethylene oxide (SAL 10^-6). Complies with ISO 7206-4, ISO 7206-6, ISO 21535, and ASTM F2996-13.

Indications for Use

Indicated for patients requiring primary or revision total hip replacement or hemiarthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, congenital dislocation, failed prior procedures, 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 Modular HA Stem (K043123)
• Apex Modular Alumina Head (K012918)
• Apex hip System Bipolar Head (K082468)
• Apex Hip System Bipolar Head (K100151)
• Apex Modular Head, +10.5mm offset (K101575)
• Apex Modular Hip System Biolox delta Femoral Head (K101451)
• Interface Acetabular System, Acetabular Insert +4 offset (K092443)
• Omni Skirted Heads (K152919)
• Apex Modular Hip Stem (K000788)
• Apex Modular Acetabular Cup (K031110)
• Apex Modular Acetabular Cup (K112779)
• Apex HCLA Acetabular Cup Liners (K062489)
• Apex HCLA Acetabular Liners (K073150)
• Biopro Bipolar Head, Models 18130-18152 (K082705)
• OMNI Interface Acetabular System (K142201)
• +4 Offset Acetabular Insert (K101976)
• ARC Monoblock Hip Stem (K133381)

Submission Summary (Full Text)

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

August 17, 2017

OMNIlife Science Christina Rovaldi Regulatory Affairs Specialist 480 Paramount Drive Raynham, Massachusetts 02767

Re: K171156

Trade/Device Name: OMNI Anseris 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. LWJ Dated: July 12, 2017 Received: July 13, 2017

Dear Christina Rovaldi:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Mark N. Melkerson -S

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) K171156

Device Name OMNI Anseris Hip Stem

#### Indications for Use (Describe)

The OMNI Anseris 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 Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

| TABLE 1: 510(k) SUMMARY | |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared | 08/03/2017 |
| Manufacturer/Distributor/Sponsor | OMNIlife Science<br>480 Paramount Drive<br>Raynham, MA 02767 |
| 510(k) Contact | Christina Rovaldi<br>Regulatory Affairs Specialist<br>OMNIlife Science<br>480 Paramount Drive<br>Raynham, MA 02767<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | OMNI Anseris Hip Stem |
| Common Name | prosthesis, hip, semi-constrained,<br>metal/ceramic/polymer, cemented or non-porous,<br>uncemented<br>prosthesis, hip, semi-constrained, metal/polymer,<br>uncemented |
| Classification | Class II per 21 CFR §888.3353 Hip joint<br>metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis. Product Code – LZO<br>Class II per 21 CFR §888.3360 Hip joint femoral (hemi-<br>hip) metallic cemented or uncemented prosthesis.<br>Product Code – LWJ |
| Primary Predicate Device | Apex Modular HA Stem<br>K043123 |
| Additional Predicate Devices | Apex Modular Alumina Head, K012918<br>Apex hip System Bipolar Head, K082468<br>Apex Hip System Bipolar Head, K100151<br>Apex Modular Head, +10.5mm offset, K101575<br>Apex Modular Hip System Biolox delta Femoral Head |
| | K101451 |
| | Interface Acetabular System, Acetabular Insert +4<br>offset, K092443 |
| | Omni Skirted Heads, K152919 |
| | Apex Modular Hip Stem, K000788 |
| | Apex Modular Acetabular Cup, K031110 |
| | Apex Modular Acetabular Cup, K112779 |
| | Apex HCLA Acetabular Cup Liners, K062489 |
| | Apex HCLA Acetabular Liners, K073150 |
| | Biopro Bipolar Head, Models 18130-18152, K082705 |
| | OMNI Interface Acetabular System, K142201 |
| | +4 Offset Acetabular Insert, K101976 |
| | ARC Monoblock Hip Stem, K133381 |
| Purpose of Submission | This traditional 510(k) premarket notification is being<br>submitted to obtain clearance for the OMNI Anseris<br>Stems to expand OMNI's product offering for total hip<br>arthroplasty. |
| Intended Use | The OMNI Anseris Hip Stem is intended for use as the<br>femoral component of a primary or revision total hip<br>replacement when used with the Apex Interface™<br>Acetabular System. The Apex Interface™ Acetabular<br>System articulates with the Apex Modular Femoral<br>Head (Cobalt Chromium or Ceramic). The femoral hip<br>stem is intended for uncemented fixation and single use<br>implantation. These prostheses may be used for hip<br>arthroplasty to treat the following conditions, as<br>appropriate:<br>• Non-inflammatory degenerative joint disease,<br>including osteoarthritis and avascular necrosis;<br>• Rheumatoid arthritis;<br>• Correction of functional deformity;<br>• Congenital dislocation;<br>• Revision procedures where other treatments or devices<br>have failed;<br>• Femoral neck and trochanteric fractures of the<br>proximal femur.<br>The OMNI Anseris Hip Stem is also intended for use in |
| | hemiarthroplasty when used with the Apex Bipolar<br>Head. For further details, please refer to the Apex |
| | Bipolar Head Instructions for Use. |
| Device Description | The OMNI Anseris Stem is a "fit and fill" femoral stem<br>with a tapered conical design and is intended for use as<br>the femoral component of a primary or revision total hip<br>replacement when |
| Sterility and Biocompatibility | The proposed devices undergo the same validated<br>sterilization process, using ethylene oxide (EO), as the<br>validated devices under the sterility assurance level<br>(SAL) of 10-6. All ethylene oxide residuals are<br>monitored and well below standard limits. In addition,<br>OMNI has developed a plan to test endotoxins on all<br>OMNIlife science device groups through Limulus<br>amebocyte lysate (LAL) testing. Products have been<br>segregated into product families based on manufacturing<br>process and material type and have generated 8 product<br>groups that will be tested for endotoxins on a quarterly<br>basis on a yearly rotation. Product will not be released if<br>the 20 EU/device limit is exceeded. |
| Substantial Equivalence Summary:<br>Technology Comparison | The proposed Anseris Stems are substantially equivalent<br>to the predicate Apex Modular Stem (K043123) in terms<br>of the fundamental scientific technology and intended<br>uses and the reference predicate in terms of design and<br>materials. Any differences between the proposed and the<br>predicates are considered minor and do not raise any<br>different questions of safety and effectiveness. |
| | The proposed devices are composed of titanium alloy,<br>unalloyed titanium plasma spray, the identical material<br>used in the manufacture of the predicate device. The<br>proposed devices have an integral neck and trunnion<br>rather than separate modular neck components that are<br>part of the predicate Apex Modular Stem system. |
| | The Anseris hip stem has a "fit and fill" approach, this<br>proposed stem will have a conical design similar to<br>OMNIs Apex Modular Stem (K043123). |
| Substantial Equivalence Summary: | The results of testing of the proposed Anseris Hip Stems |
| K171156 | Page 4 of 4 |
| Non-Clinical Testing | met the requirements for fatigue strength per ISO 7206-<br>6 and ISO 7206-4 and the range-of-motion requirement<br>per ISO 21535. These test methods are the same used<br>for the predicate device (K043123).<br>- HTR-103 Conical Hip Fatigue Testing<br>- HTR-062 Conical Tapered Stem Fatigue FEA<br>- HTR-104 ROM Analysis<br>- HTR-108 ROM Analysis with Bipolar Heads<br>- HTR-106 Conical Stem FEA per ASTM F2996-13<br>- HTR-107 Solidworks Simulation Verification<br>-HTR-109 Conical Stem Bipolar Head Impingement<br>Risk<br>Based on the indications for use, technological<br>characteristics, and the comparison to the predicate<br>devices, OMNIlife Science has determined that the<br>OMNI Anseris Hip Stem is substantially equivalent to<br>currently marketed predicate device. Based on the<br>similar intended use, technological characteristics,<br>material and testing, OMNIlife science believes the<br>proposed introduction of skirted heads to be<br>substantially equivalent to the legally marketed<br>predicate. |
| Conclusion Statement | The conclusions drawn from the nonclinical tests<br>demonstrate that the devices are safe, as effective, and<br>perform as well as or better than the legally marketed<br>device |

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