The OMNI 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 OMNI ARC™ 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 Description

The proposed devices are intended to be used for primary and revision total hip replacement.

The OMNI ARC Anteverted Neck Hip Stem offers anteverted neck options (left and right orientations) to the monoblock stem system to meet the variety of patient anatomies expected in Total Hip Arthroplasty. This design is similar to the ARC Monoblock stem designs currently marketed.

The material of the proposed OMNI ARC Anteverted Neck Hip Stems are Ti-6Al-4V E.L.I (ASTM F136)

AI/ML Overview

This document describes the regulatory submission for the "OMNI ARC Anteverted Neck Hip Stem." It is a 510(k) premarket notification, which means the manufacturer is seeking to demonstrate that their new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch through extensive clinical trials.

Therefore, the typical questions about acceptance criteria for device performance, a study proving the device meets those criteria, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable in the context of this 510(k) submission.

Here's why and what information is provided:

1. Acceptance Criteria and Reported Device Performance:

Not Applicable in the traditional sense of a clinical performance study. The submission focuses on demonstrating substantial equivalence to a predicate device (K133381 OMNI ARC Monoblock Hip Stem).
Performance is inferred through justification of equivalence. The "performance" assessment is based on demonstrating that the new design (anteverted neck options) does not introduce new risks and functions similarly to the predicate. The document states: "The proposed devices with modifications are substantially equivalent to the existing OMNI ARC Monoblock Hip Stem cleared in K133381 as the basic design, interface, fundamental technology, materials and intended use are the same."

2. Sample Size and Data Provenance:

Not Applicable. No clinical test set data from patients is described or required for this type of 510(k) submission, as it relies on substantial equivalence to a known predicate rather than new clinical data.
The "data" here refers to engineering evaluations and justifications, not patient data. The document mentions "HTR-082 ARC Monoblock Fatigue FEA Anteverted Neck" and "HTR-099 ARC Monoblock Anteverted Neck ROM" as justifications. These are likely finite element analysis (FEA) and range of motion (ROM) studies, which are engineering simulations/tests typically performed in vitro or computationally, not on patient samples.

3. Number of experts and qualifications for ground truth:

Not Applicable. As no clinical test set data from patients is being evaluated for ground truth, there are no medical experts determining a "ground truth" for diagnostic or predictive performance. The "experts" would be the engineers and designers involved in proving equivalence through design, materials, and mechanical testing.

4. Adjudication Method:

Not Applicable. No clinical data to adjudicate.

5. MRMC Comparative Effectiveness Study:

Not Applicable. This is a medical device (hip stem), not an AI/diagnostic algorithm that would assist human readers in interpretation.

6. Standalone Performance:

Not Applicable. No standalone algorithm performance is relevant for a physical implantable device.

7. Type of Ground Truth Used:

Based on engineering principles and predicate device performance. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device (K133381 OMNI ARC Monoblock Hip Stem), combined with engineering analyses (like FEA) demonstrating that the modifications do not negatively impact these characteristics.

8. Sample Size for Training Set:

Not Applicable. There is no "training set" in the context of a physical medical device. The "training" for the device's design is based on established biomechanical principles, material science, and the performance characteristics of the predicate device.

9. How Ground Truth for Training Set was Established:

Not Applicable. See point 8.

In summary, for this specific 510(k) submission (K172467):

The manufacturer, OMNIlife Science, Inc., is seeking to market the "OMNI ARC Anteverted Neck Hip Stem" by demonstrating its substantial equivalence to an already legally marketed device, the "OMNI ARC Monoblock Hip Stem" (K133381). This type of submission relies on showing that the new device's design, materials, and intended use are fundamentally the same as its predicate and that any modifications (adding anteverted neck options) do not introduce new safety or effectiveness concerns.

Instead of clinical performance data, the submission relies on:

Comparison of Indications for Use: The Indications for Use for the OMNI ARC Hip Stem are listed on page 2 and are expected to be similar or identical to the predicate device.
Device Description Comparison: The new device offers anteverted neck options, but its design is "similar to the ARC Monoblock stem designs currently marketed." The material (Ti-6Al-4V E.L.I) is also stated.
Justifications/Evaluations: The submission mentions specific justifications like "HTR-082 ARC Monoblock Fatigue FEA Anteverted Neck" and "HTR-099 ARC Monoblock Anteverted Neck ROM." These are engineering analyses (likely computational or bench testing) used to support the claim that the modifications do not introduce new risks regarding fatigue life or range of motion compared to the predicate. No clinical testing data is presented or required for a 510(k) based solely on substantial equivalence via design modifications and engineering justification.

Summary

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December 21, 2017

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

Re: K172467

Trade/Device Name: OMNI ARC Anteverted Neck 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 Dated: October 4, 2017 Received: October 5, 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 Part 807); labeling (21 CFR Part 801); medical device 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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)

K172467 Device Name OMNI ARC Anteverted Neck Hip Stem

Indications for Use (Describe)

· 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™ 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	10/4/2017
Manufacturer/Distributor/Sponsor	OMNIlife Science, Inc.480 Paramount DriveRaynham MA 02767
510(k) Contact	Christina RovaldiSr. Regulatory Affairs SpecialistOMNIlife Science480 Paramount DriveRaynham MA 02767Telephone: 774-226-1857Fax: 508-822-6030Email: crovaldi@omnils.com
Trade Name	OMNI ARC Anteverted Neck Hip Stem
Common Name	Prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented.
Classification	21 CFR 888.3353 prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncementedLZO
Predicate Device	K133381 OMNI ARC Monoblock Hip Stem
Purpose of Submission	This Traditional 510(k) premarket notification is beingsubmitted to propose modifications to the OMNI ARCMonoblock Hip Stem (K133381) by adding additionalmonoblock stem types to expand the product offering.
Intended Use	The OMNI ARC Hip Stem is intended for use as thefemoral component of a primary or revision total hipreplacement when used with the Apex Interface™Acetabular System. The Apex Interface™ AcetabularSystem articulates with the Apex Modular FemoralHead (Cobalt Chromium or Ceramic). The femoral hipstem is intended for uncemented fixation and single useimplantation. These prostheses may be used for hiparthroplasty 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 ARCTM 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 Description	The proposed devices are intended to be used for primary and revision total hip replacement.The OMNI ARC Anteverted Neck Hip Stem offers anteverted neck options (left and right orientations) to the monoblock stem system to meet the variety of patient anatomies expected in Total Hip Arthroplasty. This design is similar to the ARC Monoblock stem designs currently marketed.The material of the proposed OMNI ARC Anteverted Neck Hip Stems are Ti-6Al-4V E.L.I (ASTM F136)
Substantial Equivalence Summary	The proposed devices with modifications are substantially equivalent to the existing OMNI ARC Monoblock Hip Stem cleared in K133381 as the basic design, interface, fundamental technology, materials and intended use are the same.The use of the new OMNI ARC Anteverted Neck Hip Stem components with the existing ARC Monoblock Hip Stem does not introduce any new risks of safety or efficacy.Testing was not conducted but the devices were evaluated and no-testing justifications were written
	The following justifications were written to explain thesafety and effectiveness of the OMNI ARC Hip Stemwith the proposed modifications. The modifications donot raise any new safety or effectiveness concerns.
	- HTR-082 ARC Monoblock Fatigue FEA AntevertedNeck
	- HTR-099 ARC Monoblock Anteverted Neck ROM
	The justifications are described in section 12, DeviceDescription.
	Based on the design, fundamental technology, identicalmaterial, intended use and technologicalcharacteristics, OMNIlife science believes the proposedOMNI ARC Anteverted Neck Hip Stem devices to besubstantially equivalent to legally marketed predicates.
Conclusion Statement	OMNIlife science has demonstrated the proposedOMNI ARC Anteverted Neck Hip Stem is substantiallyequivalent to the predicate device based uponindications for use, design, test results and the samefundamental scientific technology.

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Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
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.(b)
Classification. Class II.