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.

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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Apex ARC™ Hip Stem, focusing on acceptance criteria and the study proving conformance.

Important Note: The provided document is a 510(k) Pre-market Notification for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving efficacy or meeting specific acceptance criteria through extensive clinical studies as one might find for a novel drug or a high-risk device requiring a PMA.

Description of Acceptance Criteria and the Study Proving the Device Meets Acceptance Criteria

The document states that the Apex ARC™ Hip Stem (specifically the new Size 0) is substantially equivalent to its predicate devices (Apex ARC Hip Stem K090845 and K111193). The primary method used to demonstrate this substantial equivalence, and thus "meet acceptance criteria," is through non-clinical testing and comparison of design features, materials, and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence based on a new size of an existing device, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for clinical outcomes, but rather demonstrate that the new size performs comparably to the predicate device in relevant biomechanical tests.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance
Fatigue Strength: Must meet or exceed established standards for hip femoral components.	Testing performed per ISO 7206-6, ISO-7206-4, ISO 7206-8, and ASTM 2068-09. (Specific numerical results not provided in this summary, but the conclusion is that the device is substantially equivalent, implying it met these standards.)
Range of Motion (ROM): Must exhibit acceptable ROM.	Evaluation performed per ISO 21535. (Specific numerical results not provided, but the conclusion implies acceptable performance.)
Biocompatibility: (Implicit for titanium alloy and HA coating)	Manufactured using equivalent materials to predicate(s). (Implies biocompatibility is assumed to be met based on predicate).
Material Properties: (Implicit)	Manufactured using equivalent materials to predicate(s).
Design Features, Intended Use, Indications for Use: (Implicit)	Compared to predicate device(s) and found to be substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as this is a non-clinical mechanical and material testing summary. For such tests, the sample size typically refers to the number of individual test articles (e.g., hip stems) subjected to each specific test. This information is usually detailed in the full test reports, which are not provided here.
Data Provenance: The testing was "conducted," implying laboratory testing. The country of origin for the data is implied to be within the scope of the submitter, OMNIlife science, Inc., based in East Taunton, MA, USA, and adherence to international standards (ISO, ASTM). The data is prospective in the sense that the new size 0 was manufactured and then tested.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. For non-clinical, biomechanical testing of a medical device, "ground truth" is established by relevant engineering standards (ISO, ASTM) and the objective measurements obtained from properly calibrated testing equipment. There is no expert consensus involved in establishing the "ground truth" for the mechanical properties of a hip stem.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image-based diagnostic studies where human interpretation of data is involved. Here, the "study" is a series of non-clinical tests with objective, quantitative outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC comparative effectiveness study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not Applicable. This device is a physical hip stem, not a software algorithm or AI-driven diagnostic tool. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For the non-clinical tests (Fatigue Strength, ROM Evaluation), the "ground truth" is defined by established engineering standards and specifications (ISO 7206 series, ASTM 2068-09, ISO 21535) for hip implant performance. The device's measured performance against these standards constitutes the "ground truth" for its mechanical properties. There is no pathology, outcomes data, or expert consensus used for the "ground truth" in this context.

8. The Sample Size for the Training Set

Not Applicable. This report does not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the Study Proving Device Acceptance Criteria:

The "study" proving the Apex ARC™ Hip Stem (Size 0) meets its "acceptance criteria" (which in this 510(k) context means demonstrating substantial equivalence) is a non-clinical testing program.

This program involved:

Fatigue Strength Testing: Performed according to international standards ISO 7206-6, ISO-7206-4, ISO 7206-8, and ASTM 2068-09. This testing assesses the material's ability to withstand repeated stress without failure, simulating the forces experienced during daily activity.
Range of Motion (ROM) Evaluation: Performed according to ISO 21535. This evaluates the articulation capabilities of the hip stem in conjunction with other components to ensure proper biomechanical function and prevent impingement.

The conclusion drawn from these studies is that the "addition of one new stem size for the Apex ARC Hip Stem, in our opinion, is substantially equivalent to the predicate device." This implicitly means that the new size 0 performed comparably to the predicate devices and met the relevant performance standards for hip stems. No clinical studies were performed to support this submission.

Summary

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Apex ARC ™ Hip Stem

7 December, 2011

Submitter	OMNIlife science, Inc.50 O'Connell WayE. Taunton MA 02718
Contact	Christine NassifDirector, Regulatory Affairs774-226-1871(508) 822-6030 (fax)
Preparation Date	7 December, 2011
Device Name	Apex Hip System
Trade Name	Apex ARC ™ Hip Stem
Sizes	Apex ARC Hip Stem, Size OApex ARC Hip Stem, Size 0 HA Coated
Common name/Classification	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesisHip 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.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.

Page 1 of 2

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Indications forUse	The Apex ARC™ Hip Stem is intended for use as the femoral component of aprimary, or revision total hip replacement when used with the Apex Interface™Acetabular System. The Apex Interface™ Acetabular System articulates with theApex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stemis intended for uncemented fixation and single use implantation. These prosthesesmay be used for hip arthroplasty to treat the following conditions, as appropriate:• Non-inflammatory degenerative joint disease, including osteoarthritis andavascular 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 hemiarthroplastywhen used with the Apex Bipolar Head.
	The Apex Hip System Bipolar Head is intended for use in combination with an ApexHip System femoral stem for uncemented primary or revision hemiarthroplasty ofthe 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 havefailed.
Predicate DeviceComparison	The Apex ARC Hip Stem is manufactured, packaged, and sterilized using equivalent materialsand processes. The subject device(s) is also substantially equivalent to its predicate(s) basedon comparison of design features, intended use, and indications for use. The fundamentalscientific technology of the modified device(s) has not changed relative to the predicatedevice(s). The safety and effectiveness of the devices has not changed relative to thepredicate devices. The safety and effectiveness of the Apex ARC Hip Stem is adequatelysupported by the substantial equivalence information, materials information, and analysisdata provided within this Premarket Notification.
Non-Clinical TestSummary	The following tests were conducted:• Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09• ROM Evaluation per ISO 21535
Clinical TestSummary	No clinical studies were performed.
Conclusions	The addition of one new stem size for the Apex ARC Hip Stem, in our opinion, is substantiallyequivalent to the predicate device.

Page 2 of 2

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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 (800) 638-2041 or (301) 796-7100 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

· 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.

· 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

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

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