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 (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 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 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 Description

The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The height of the anterior and posterior lateral protrusions (Lateral T-Flange) was reduced on Size 1 and 2 ARC Hip Stems. Three new neck sizes are offered, Long Neutral, Long 8 ° Varus/Valgus and Anteverted. 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

The Apex Hip System ARC™ Hip Stem is a medical device and the provided text describes its acceptance criteria and the study conducted to prove it meets them.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Apex Hip System ARC™ Hip Stem are based on demonstrating substantial equivalence to a predicate device (Apex ARC Hip Stem - K090845). This equivalence is primarily shown through non-clinical performance testing.

Acceptance Criteria Category	Specific Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance
Intended Use	Primary and revision total hip replacement (same as predicate)	Met
Design	- T-Flange reduction (by half on Size 1 and 2 ARC Hip Stem)	Met (Design change described and tested for performance)
	- Curved, rectangular tapered stem (same as predicate)	Met
	- New neck designs: Long neutral, long 8° varus/valgus, anteverted	Met (Compatibility and performance tested)
Materials	- Apex ARC Hip Stem (Ti6Al4V per ASTM F136) (identical to predicate)	Met
	- Plasma spray Titanium coating (Unalloyed titanium plasma spray per ASTM F1580) (identical to predicate)	Met
	- Hydroxyapatite Coating (Hydroxyapatite plasma spray coating per ASTM F1185) (identical to predicate)	Met
	- Apex ARC Modular Neck (CoCr alloy per ASTM F1537) (identical to predicate)	Met
Packaging & Sterilization	- Sterilization (Ethylene oxide) (identical to predicate)	Met
	- SAL (10^-6^) (identical to predicate)	Met
	- Packaging (Paper Board Box, Double Tyvek inner pouch) (identical to predicate)	Met
Non-Clinical Performance	- Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09 (demonstrate equivalence/safety after design changes)	Met (Tests conducted)
	- ROM evaluation per ISO 21535 (demonstrate equivalence/safety after design changes)	Met (Tests conducted)

2. Sample size used for the test set and the data provenance

The document states, "Non-Clinical Test: The following tests were conducted." It then lists fatigue strength testing and ROM evaluation. However, the exact sample size (number of devices or components tested) for these non-clinical tests is not specified in the provided text.

The data provenance is from non-clinical laboratory testing performed on the device itself (or its components) according to specified ISO and ASTM standards. No human or animal data is involved; thus, there is no country of origin or retrospective/prospective distinction in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a mechanical implant, and the acceptance criteria for performance are based on engineering standards and physical testing, not subjective expert assessment of medical images or patient outcomes as would be the case for an AI device.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI studies where human experts disagree on interpretations. For mechanical performance testing of an implant, the results are objective measurements against defined standards, not subject to expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a hardware medical device (hip stem), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and assessments of human reader improvement with AI assistance are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical implant, not an algorithm, so "standalone performance" in the context of AI does not apply.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective measurements against recognized industry standards (ISO and ASTM) for mechanical properties (fatigue strength) and range of motion. The predicate device's performance under these same standards effectively sets the benchmark for "ground truth" for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This section usually refers to the data used to train an AI model. Since this is a physical medical device, there is no "training set" in this context. The manufacturing and design process follows established engineering principles and quality systems; it's not "trained" on data.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a physical device, this question is not relevant.

Summary

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JUN 2 7 2011

510(k) Summary

Apex Hip System ARC ™ Hip Stem
Submitter	OMNIlife science, Inc.50 O'Connell WayE. Taunton MA 02718	Contact	Radhika PondicherryRegulatory Affairs774-226-1852(508) 822-6030 (fax)
Preparation Date	01 June, 2011
Device NameTrade Name	Apex Hip SystemApex ARC ™ Hip Stem,
Sizes	Apex ARC Hip Stem, Size 1Apex ARC Hip Stem, Size 1 HA CoatedApex ARC Hip Stem, Size 2Apex ARC Hip Stem, Size 2 HA CoatedApex ARC Hip System Modular Neck, AntevertedApex ARC Hip System Modular Neck, Long NeutralApex ARC Hip System Modular Neck, Long 8° Varus/Valgus
Common name/Classification	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesisHip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncementedprosthesisHip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Regulatory ClassProduct Code	Class II per 21 CFR § 888.3358, §888.3353, §888.339021 CFR Product Code- LPH, LZO, MEH, KWY
Legally MarketedPredicate Device(s)	K090845- Apex ARC™ Hip Stem
Device Description	The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks thatconnect to the tapered hole in the stem. The height of the anterior and posterior lateralprotrusions (Lateral T-Flange) was reduced on Size 1 and 2 ARC Hip Stems. Three new neck sizesare offered, Long Neutral, Long 8 ° Varus/Valgus and Anteverted. The necks are compatible withthe Cobalt Chromium and Ceramic modular heads, and may be used with head diameters andoffsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunctionwith the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty.

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K111193/(Page 2 of 3)

Indications for Use

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 (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 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.

	Apex ARC Hip Stem,Additional necks andLateral T-Flange stemdesign change(subject device)	Apex ARC Hip Stem(K090845)
Intended Use
Primary and revision total hipreplacement	Yes	Yes
Design
T-Flange	T-Flange was reduced byhalf on the size 1 and size 2ARC Hip Stem.	ARC Hip Stem T-flangesize 1 and size 2
Stem Design	Curved, rectangular taperedstem.	Curved, rectangulartapered stem.
Neck Design	Long neutral, long 8 °varus/valgus, anteverted	Neutral, 8° and 12 °varus/valgus
Materials
Apex ARC Hip Stem	Identical to K090845	Ti6Al4Vper ASTM F136
Plasma spray Titaniumcoating	Identical to K090845	Unalloyed titaniumplasma sprayper ASTM F1580
Hydroxyapatite Coating	Identical to K090845	Hydroxyapatite plasmaspray coatingper ASTM F1185
Apex ARC Modular Neck	Identical to K090845	CoCr alloy

Predicate Device Comparison

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K1111193 (pg. 3 of 3)


PACKAGING	AND
STERILIZATION
Sterilization	Identical to K090845	Ethylene oxide
SAL	Identical to K090845	$10^{-6}$
Packaging	Identical to K090845	Paper Board Box, DoubleTyvek inner pouch

Non-Clinical Test

The following tests were conducted:

Summary

The following tests were conducted

t Fatigue Strength Testing per ISO 7206-6, ISO-7206-4, ISO 7206-8 and ASTM 2068-09
. ROM evaluation per ISO 21535

Clinical Test No clinical studies were performed. Summary

The addition of 3 new neck options; Long Neutral, Long 8 ° Varus/Valgus and Anteverted, and the Conclusions reduction of height of the anterior and posterior lateral protrusions (Lateral T-Flange) for the Size 1 and 2 ARC Hip Stems described in this submission are substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

OMNIlife Science, Inc. % Ms. Radhika Pondicherry Regulatory Affairs 50 O'Connell Way East Taunton, Massachusetts 02718

JUN 2 7 2011

Re: K111193 Trade/Device Name: Apex ARCTM Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: Class II Product Code: LZO, MEH, LPH, KWY Dated: June 1, 2011 Received: June 2, 2011

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.

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

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Page 2 – Ms. Radhika Pondicherry

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/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,

Eunel Keith

For 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: K111193

Device Name: Apex Hip System 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.

AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (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

for M.Meikerson

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

510(k) Number K111193

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.