The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cup are intended for uncemented fixation and single use implantation. These prostheses may be used for 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.

Device Description

Apex Modular Head sizes 28, 32, 36, and 40 mm with a + 10.5mm offset

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Apex Modular Heads, +10.5mm offset:

Acceptance Criteria and Device Performance Study for Apex Modular Heads, +10.5mm offset

This submission (K101575) is for a medical device seeking substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" are primarily established by demonstrating equivalency to the predicate devices through non-clinical testing, rather than defining novel performance thresholds for clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence based on non-clinical testing, the "acceptance criteria" are implicitly met by demonstrating that the subject device's performance is comparable to or better than previously cleared predicate devices for relevant mechanical and material properties. The device performance is reported as meeting the specified standards, thereby indicating compliance with the implicit acceptance criteria for safety and effectiveness in comparison to the predicates.

Acceptance Criteria (Implied by Predicate Equivalence & Standards)	Reported Device Performance
Mechanical Performance:
Range of Motion (ROM) per ISO-21565-2007	Conducted; results imply compliance with established ROM characteristics for hip prostheses and comparability to predicates.
Finite Element Analysis (FEA) per ISO-7206-4	Conducted; results imply structural integrity and comparability to predicates under simulated loading.
Fatigue Strength per ISO 7206-6, ASTM F2068-09	Conducted; results imply sufficient fatigue life and comparability to predicates under cyclic loading.
Material Composition:
Wrought cobalt chromium (per ASTM F1537)	Device made of Wrought cobalt chromium (per ASTM F1537)
Sterilization:
Ethylene oxide sterilization with SAL 10⁻⁶	Device sterilized with Ethylene oxide with SAL 10⁻⁶ (comparable to predicates)
Packaging:
Paper Board Box, Double Tyvek inner pouch	Device packaged in Paper Board Box, Double Tyvek inner pouch (comparable to predicates)
Design Characteristics (for equivalency):
Taper Design: Size "N" bore in ASTM F1636-95	Device has Size "N" bore in ASTM F1636-95 (identical to predicates)
Head Diameters: 28, 32, 36, 40 mm	Device offered in 28, 32, 36, 40 mm (identical to predicates)
Offset: +10.5mm	Device explicitly has +10.5mm offset (the differentiating feature being evaluated for equivalence)

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of number of physical units tested beyond the mention of "tests were conducted." For mechanical and material testing, sample sizes are typically defined by the specific ASTM/ISO standards referenced (e.g., minimum number of specimens for fatigue testing). The provided text indicates that the tests were conducted, implying adequate sample sizes were used as required by the standards.
Data Provenance: Not explicitly stated (e.g., specific country or lab). The tests are described as "Non-Clinical Test Summary," meaning they were laboratory-based and not derived from human subjects. The reference to ISO and ASTM standards suggests internationally recognized testing protocols. Retrospective or prospective designations are not applicable as these are non-clinical lab tests.

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

Not applicable. For this type of mechanical and material performance testing, "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and the results obtained from the tests themselves using calibrated equipment. There is no concept of expert consensus for establishing ground truth in this context, unlike clinical studies involving image interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" refers to the mechanical and material testing of the device components. Adjudication methods (like 2+1, 3+1) are employed in clinical studies, particularly in situations where there is subjective human interpretation or diagnostic agreement required (e.g., radiology reads).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC comparative effectiveness study was conducted. This device is seeking clearance based on substantial equivalence to predicate devices through non-clinical performance data and material specifications.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant (hip prosthesis), not a software algorithm or AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used

Engineering and Material Standards Compliance, and Mechanical Test Results: The "ground truth" for this device's performance is established by demonstrating compliance with recognized international standards (ISO, ASTM) for mechanical properties, material composition, and manufacturing processes relevant to hip implants. The results of the non-clinical tests (ROM, FEA, Fatigue Strength) serve as the evidence to support this compliance and demonstrate substantial equivalence to the predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant and does not involve AI or machine learning algorithms that require a "training set."

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

Not applicable. No training set was used or required for this device.

Summary

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K101575 (pg 1/2)

JUN 3 0 2010

Apex Modular Heads, +10.5mm offset

04June, 2010

Submitter OMNI life science, Inc. Contact 50 O'Connell Way E. Taunton MA 02718

Radhika Pondicherry Regulatory Affairs 774-226-1852 (508) 822-6030 (fax)

Preparation Date	04 June 2010
Device Name	APEX Modular Head, +10.5mm offset
Trade Name	APEX Modular Head, +10.5mm offset
Common/Classification Name	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Regulatory Class	Class II per 21 CFR §888.3358
Product Code	LPH
Legally Marketed Predicate Device(s)	K000788 Apex Modular Hip Stem, 28 and 32 mm heads, August 02.2000 K073150 ApeX-LNK Poly™ Acetabular Cup Liners and 36 mm Heads, February 27, 2008) K100555 ApeX-LNK Poly Acetabular Liners and Apex Modular Head, 40mm, March 29, 2010)
Device Description	Apex Modular Head sizes 28, 32, 36, and 40 mm with a + 10.5mm offset
Indications for Use	The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cup are intended for uncemented fixation and single use implantation. These prostheses may be used for 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.

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Predicate Device Comparison

	Apex Hip System, +10.5 offset (subject device)	Apex Modular femoral heads (K000788) (K073150) (K100555)
Intended Use
Primary and revision total hip replacement	Yes	Yes
Design
Taper Design	Size "N" bore in ASTM F1636-95	Size "N" bore in ASTM F1636-95
Head Diameters	28, 32, 36, 40 mm	28, 32, 36, 40mm
Offsets (mm)	+10.5	-3.5, +0, +3.5, +7
Materials
Femoral Heads	Wrought cobalt chromium	Wrought cobalt chromium
Standards	ASTM F1537	ASTM F1537
PACKAGING AND STERILIZATION
Sterilization	Ethylene oxide	Ethylene oxide
Sal	$10^{-6}$	$10^{-6}$
Packaging	Paper Board Box, Double Tyvek inner pouch	Paper Board Box, Double Tyvek inner pouch

Non-Clinical Test The following tests were conducted: Summary

ROM analysis per ISO-21565-2007 .
Finite Element Analysis per ISO-7206-4 .
Fatigue Strength Testing per ISO 7206-6,ASTM F2068-09 .

Clinical Test Summary

No clinical studies were performed.

Conclusions

The Apex Modular Head is substantially equivalent to the predicate devices.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

JUN 3 0 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

OMNIlife science, Inc. % Radhika Pondicherry Regulatory Affairs Specialist 50 O'Connell Way E.Taunton MA 02718

Re: K101575

Trade/Device Name: Apex Modular Head Size 28, 32, 36 and 40mm +10.5 offset Regulation Number: 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porqus-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: June 4, 2010 Received: June 7, 2010

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. 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

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Page 2 - Ms. Radhika Pondicherry

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.

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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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 : K101575 (pg i/i)

Device Name: Apex Modular Head, +10.5mm offset

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.

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)

Page 1 of 1

Peter D. Rummer m2 mpf

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

510(k) Number__

...

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.