The Apex Modular™ Ceramic Femoral Heads are intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup or bipolar component. This prosthesis is intended for single use implantation, and 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

The Apex Modular Hip System BIOLOX® delta Femoral Head is composed of an alumina matrix composite, the femoral heads include diameters ranging from 28mm to 40mm with various offsets.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the APEX Modular Hip System BIOLOX® delta Femoral Head, based on the provided document:

This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, independent performance acceptance criteria through clinical studies. Therefore, the "acceptance criteria" here are implicitly linked to the performance characteristics of the legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a medical implant, the "acceptance criteria" are not explicit performance metrics in the way one might find for a diagnostic device (e.g., sensitivity, specificity). Instead, they are related to demonstrating that the new device is as safe and effective as the predicate devices, primarily through design, material, and mechanical property comparisons. There are no direct "reported device performance" metrics in terms of clinical outcomes, but rather a demonstration of comparable mechanical performance.

Category	"Acceptance Criteria" (Implicit from Predicate Comparison)	Reported Device Performance (Subject Device)
Intended Use	Must be identical or very similar to predicate devices for modular head, primary and revision THA, cementless.	Yes, cementless. (Matches predicate for modular head, primary and revision THA)
Design: Taper	Must be identical to predicate devices.	12/14 (Matches predicate)
Design: Head Diameters & Offsets	Must cover similar ranges and specifications as predicate devices, with reasonable justification for any variations (e.g., expansion of available sizes).	28-40mm (Wider range than K012918, K073150 which are 28-36mm, but includes 40mm which is available in K100555). Specific offsets are generally consistent or offer expanded options.
Materials	Must be biocompatible and possess mechanical properties comparable to or superior to predicate devices (e.g., alumina for ceramic heads, CoCr Alloy for non-ceramic heads, titanium alloy/CoCr alloy for stem trunion). Specific material composition must be documented.	BIOLOX delta (Alumina matrix composite, 72-75% Al2O3+, 24-26% Z2O3), Titanium alloy/CoCr alloy for Stem Trunion. (Comparable to BIOLOX forte (99.7% Al2O3) in predicate ceramic heads, and CoCr Alloy for another predicate head, with a specified alternative ceramic composition).
Packaging & Sterilization	Must be equivalent to predicate devices to ensure sterility and integrity.	Peelable Tyvek® pouches, double pouched, cardboard box with foam, tamper resistant labels; inner pouch polyethylene with peelable Tyvek® panel. Ethylene oxide sterilization to 10-6 SAL. (Matches predicate packaging and sterilization methods).
Mechanical Performance	Demonstrate equivalence in mechanical properties through non-clinical testing, particularly burst strength and taper locking integrity, referencing established ISO standards.	- Component testing of BIOLOX delta ball heads (28-12/14 L) on CoCr and titanium test tapers per CeramTec Procedure VA 02 04 4129, ISO-7606-10.- Influence of diameter and neck length on burst strength of BIOLOX delta ball heads with taper type 12/14, per ISO-7206-10 setup. (These tests aimed to show comparable mechanical integrity and performance to the predicate BIOLOX forte heads.)
Biocompatibility	Residuals of sterilization agents must be within acceptable limits (e.g., ETO residuals).	ETO Residuals per ANSI/AAMI/ISO 10993-7. (Indicates compliance with biocompatibility standards for ETO sterilization).

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

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There was no "test set" of patient data used. The testing was non-clinical, focusing on device components. The specific number of femoral heads or tapers tested in the mechanical studies is not provided, only the types of tests performed.
Data Provenance: The data is from non-clinical bench testing (mechanical and material characterization). There is no patient data, so country of origin or retrospective/prospective status is not applicable.

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

Not applicable. There was no "ground truth" derived from human experts for a clinical test set. The ground truth for the non-clinical tests would be the established chemical, physical, and mechanical properties of the predicate materials and devices, as defined by relevant ISO standards and material specifications. The expertise would lie with the engineers and scientists conducting the testing and comparing the results against these established standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring 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 hip implant device, not a diagnostic imaging device involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance and material specifications of legally marketed predicate devices and the adherence to recognized industry standards (e.g., ISO for mechanical testing, ANSI/AAMI/ISO for ETO residuals). The goal was to demonstrate that the new device meets or exceeds the performance characteristics of its predicates.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of machine learning or clinical trials. This is a physical medical device.

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

Not applicable. As there was no training set, there was no ground truth for one.

Summary

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JUN 2 2 2010

APEX Modular Hip System BIOLOX® delta Femoral Head

May 24, 2010

Radhika Pondicherry OMNI life science, Inc. Submitter Contact 50 O'Connell Way Regulatory Affairs . E. Taunton MA 02718 774-226-1852 (508) 822-6030 (fax)

Preparation Date	24 May2010
Device Name
Common Name	Hip joint ceramic, uncemented prosthesis
Trade Name	APEX Modular Hip System BIOLOX® delta Femoral Head
Classification Name	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncementedprosthesis
Regulatory Class	Class II per 21 CFR §888.3353
Product Code	LZO
Legally MarketedPredicate Device(s)	K012918- Apex Modular™ Alumina Femoral Head, November 27, 2001 K073150- ApeX-LNK Poly Acetabular Cup Liners- 36mm Alumina Femoral Heads, February 27, 2008 K100555- ApeX-LNK Poly Acetabular Liners and Apex Modular Head, March 29, 2010
Device Description	The Apex Modular Hip System BIOLOX® delta Femoral Head is composed of an alumina matrixcomposite, the femoral heads include diameters ranging from 28mm to 40mm with variousoffsets.
Indications for Use	The Apex Modular™ Ceramic Femoral Heads are intended for use in combination with theApex Modular Hip Stem as the femoral component in total hip replacement procedures. Thisceramic head is intended to articulate with a polyethylene or metal-backed polyethyleneacetabular cup or bipolar component. This prosthesis is intended for single use implantation,and 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

Page 1 of 2

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	Delta Femoral head(subject device)	Alumina Femoral head(K012918, K 073150)	Apex ModularHead(K100555)
INTENDED USE
Modular Head,primary and revisionTHA	Yes, cementless	Yes, cementless	Yes, cementless
DESIGN
Taper design	12/14	12/14	12/14
Head Diameters	28-40mm	28-36mm	40mm
Head Size & Offsets	28-+0,+3.5,-3.5	28- +0,+3.5,-3.5	40mm- +0,+3.5,+7,-3.5
	32-+0,+4,+7,-4	32- +0,+4,-4
	36-+0,+4,+8,-4	36-+0,+4,-4
	40-+0,+4,+8,-4	40mm- not available inAlumina material
MATERIALS	BIOLOX delta	BIOLOX forte	CoCr Alloy
Ceramic Head	72-75 %Al2O3+,24-26 % Z2O3	99.7% Al2O3	ASTM-1537
Stem Trunion	Titanium alloyCoCr alloy	Titanium alloyCoCr alloy	Titanium alloyCoCr alloy
PACKAGINGANDSTERILIZATION
Packaging	Peelable Tyvek®pouches (1073BTyvek®/2.5mlMylar®),doublepouched, in acardboard box, withfoam inserts, andtamper resistantouter labels; theinner pouch for theceramic heads willbe polyethylenewith a peelableTyvek®panel.	Peelable Tyvek®pouches (1073BTyvek®/2.5mlMylar®), doublepouched, in a cardboardbox, with foam inserts,and tamper resistantouter labels; the innerpouch for the ceramicheads will bepolyethylene with apeelable Tyvek®panel.	Paper Board Box,Double Tyvek innerpouch
Sterilization	Ethylene oxide	Ethylene oxide	Ethylene oxide
	10-6	10-6	10-6

Non-Clinical Test Summary

Predicate Device Comparison

The following tests were conducted:

Component testing of BIOLOX forte ball head 32-12/14 L on CoCr test tapers and BIOLOX . delta ball heads 28-12/14 L on CoCr test tapers supplied by OMNIIife science.- CeramTec Procedure VA 02 04 4129, ISO-7606-10
Component testing of BIOLOX delta ball heads 28-12/14 L on titanium test tapers . supplied by OMNIlife science. CeramTec Procedure VA 02 04 4129, ISO-7606-10
Influence of diameter and neck length on burst strength of BIOLOX forte and BIOLOX . delta ball heads with taper type 12/14- Burst test setup as per ISO-7206-10
ETO Residuals per ANSI/AAMI/ISO 10993-7. .

Clinical Test Summary

No clinical studies were performed.

Conclusions

The - APEX Modular Hip System BIOLOX® delta Femoral Head is substantially equivalent to the predicate devices.

Page 2 of 2

510(k)s-Apex Modular BIOLOX delta Head

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

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

JUN 2 2 2010

OMNI life science, Inc. % Ms. Radhika Pondicherry Regulatory Affairs 50 O'Connell Way East Taunton, Massachusetts 02718

Re: K101451

Trade/Device Name: APEX Modular Hip System BIOLOX delta Femoral Head Regulation Number: 21 CFR 888.3353

Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: II Product Code: LZQ Dated: May 24, 2010 Received: May 25, 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Daniel Keane

( 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 (if known): 长 | 0|45 |

Device Name: APEX Modular Hip System BIOLOX delta Femoral Head

• 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)

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Saustin for mxn
(Division Sign-Off)

gical, Orthopedic. and Restorative Devices

510(k) Number K101451

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.