The Ortho Development Biolox Delta Ceramic Femoral Head is inteded for use in total hip arthroplasty procedures with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the stem) and the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem).

Total hip arthroplasty is indicated for the following conditions:

Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post l . traumatic arthritis.
1. Previously failed hip surgery.
Fractures of the femoral neck or head. 3.
Avascular necrosis of the femoral head. 4.
Congenital dysplasia or other structural abnormalities where sufficient bone stock ട്. exists to properly seat the prosthesis.

Device Description

The Ortho Development Biolox Delta Ceramic Femoral Heads mate with the existing Ortho Development Ovation and Encompass 12/14 taper femoral hip stems and articulate against Ortho Development polyethylene acetabular liners. The femoral heads are available in 28mm, 32mm, and 40mm diameters in a variety of offsets.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Ortho Development Biolox Delta Ceramic Femoral Heads. The submission asserts substantial equivalence to previously cleared devices based on similarities in design, materials, manufacturing, and mechanical performance. The "study" proving the device meets the acceptance criteria is a series of mechanical tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily states that mechanical testing data demonstrates equivalence to currently marketed devices and the ability to withstand expected in vivo loading. It references "burst fracture, taper dissemble (pull off) and wear tests as described in the Summary of Design Control Activities." However, the specific acceptance criteria (e.g., minimum load for burst fracture, maximum wear rate) and the numerical results for the Ortho Development Biolox Delta Ceramic Femoral Heads are not detailed within this Summary of Safety and Effectiveness. The document relies on comparison to predicate devices rather than absolute performance metrics being explicitly stated as acceptance criteria within this summary.

Based on the information provided, a table explicitly outlining acceptance criteria and numerical performance is not entirely possible, as the specific criteria are only generically mentioned as being "equivalent" to predicates.

Acceptance Criteria (Inferred/Generic)	Reported Device Performance (Inferred/Generic)
Ability to withstand expected in vivo loading (per predicate device performance)	Demonstrates equivalence to currently marketed devices and able to withstand expected in vivo loading.
Performance in burst fracture test (per predicate device performance)	Mechanical testing data demonstrates equivalence to currently marketed devices... as described in the Summary of Design Control Activities.
Performance in taper disassemble (pull off) test (per predicate device performance)	Mechanical testing data demonstrates equivalence to currently marketed devices... as described in the Summary of Design Control Activities.
Performance in wear test (per predicate device performance)	Mechanical testing data demonstrates equivalence to currently marketed devices... as described in the Summary of Design Control Activities.

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

Sample Size for Test Set: Not specified in the provided summary. Mechanical testing typically involves a certain number of samples for each test (e.g., 5, 10, or more per test type), but the exact numbers are not detailed here.
Data Provenance: The tests are conducted by the manufacturer, Ortho Development Corporation. The data would be prospective for the specific device being submitted, generated in a laboratory setting. There is no information about country of origin of data or use of retrospective data in this summary.

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

This type of information is not applicable to this device and study. The "ground truth" for mechanical testing of an orthopedic implant is typically established by engineering standards (e.g., ISO, ASTM) and the performance of well-established predicate devices, not by expert medical consensus on individual cases. The "study" here is a set of mechanical engineering tests, not a clinical study involving human patients or evaluations by medical experts.

4. Adjudication Method for the Test Set

This is not applicable to mechanical laboratory testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies or image review where multiple human readers assess data and discrepancies need to be resolved. For mechanical tests, the results are typically quantitative measurements, and the interpretation and reporting are done by test engineers.

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

This is not applicable. This submission is for a physical orthopedic implant (a ceramic femoral head) and involves mechanical testing, not an AI-driven diagnostic or assistive device that would involve human readers.

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

This is not applicable. This submission is for a physical orthopedic implant and does not involve any algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" used for this type of device and study is primarily engineering standards and the established performance characteristics of predicate devices. The goal is to demonstrate that the new device performs at least as well as, or equivalently to, devices already on the market that have a known safety and effectiveness profile through their long-term clinical use and prior mechanical testing.

8. The Sample Size for the Training Set

This is not applicable. This is a physical device undergoing mechanical testing, not a machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a mechanical testing study of a physical implant.

Summary

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2011

	Summary of Safety and Effectiveness

NAME OF SPONSOR:	Ortho Development Corporation
	12187 South Business Park Drive
	Draper, Utah 84020
510(k) CONTACT:	Tom Haueter
	Regulatory Affairs Manager
	Telephone: (801) 553-9991
	Facsimile: (801) 553-9993
	Email: thaueter@orthodevelopment.com
DATE PREPARED:	Date: June 13, 2011
PROPRIETARY NAME:	Ortho Development Biolox Delta Ceramic Femoral Heads
COMMON NAME:	Femoral head
CLASSIFICATION:	21 CFR 888.3353, Hip joint metal/ceramic/polymer semi-constrained cemented or
	nonporous uncemented prosthesis; Class II device
DEVICE PRODUCT CODE:	LZO
PREDICATE DEVICES:	Ortho Development Ceramic Femoral Head with Press-fit Stems
	Ortho Development Corp.
	(K053587)

	Ortho Development Ceramic Femoral Head
	Ortho Development Corp.
	(K060577)

	Smith & Nephew Biolox Delta Ceramic Femoral Heads
	Smith & Nephew, Inc.
	(K083762)

DEVICE DESCRIPTIONS:

INDICATIONS FOR USE:

The Ortho Development Biolox Delta Ceramic Femoral Head is inteded for use in total hip arthroplasty procedures with the Ovation Hip Stem System (indicated for uncemented, biological fixation of the Encompass Hip Stem System (indicated for both cemented and uncemented, biological fixation of the stem).

Total hip arthroplasty is indicated for the following conditions:

Notably impaired hip joints due to osteoarthritis and/or post traumatic arthritis. 1.
1. Previously failed hip surgery.
1. Fractures of the femoral neck or head.
1. Avascular necrosis of the femoral head.
1. Congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

BASIS OF SUBSTANTIAL EQUIVALENCE:

Ortho Development Biolox Delta Ceramic Femoral Heads are substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, size range, manufacturing methods, packaging, sterilization method, and mechanical performance.

Mechanical testing data demonstrates that the Ortho Development Biolox Delta Ceramic Femoral Heads are equivalent to currently marketed devices and able to withstand expected in vivo loading. This is demonstrated in burst fracture, taper disassemble (pull off) and wear tests as described in the Summary of Design Control Activities.

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Image /page/1/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" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines extending from the eagle's head.

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

Ortho Development Corporation % Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020

SEP 2 1 2011

Re: K111936

Trade/Device Name: Ortho Development Biolox Delta Ceramic Femoral Head 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 Dated: August 19, 2011 Received: August 22, 2011

Dear Mr. Haueter :

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. Ilisting 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 - Mr. Tom Haueter

forth in the quality systems (OS) 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.lda.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.

Eric Keith

C' 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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Indication for Use Form Ortho Development Biolox Delta Ceramic Femoral Head 510(k)

510(k) Number (if known): K111936

Device Name: Ortho Development Biolox Delta Ceramic Femoral Head

Indications for Use:

Total hip arthroplasty is indicated for the following conditions:

Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post l . traumatic arthritis.
1. Previously failed hip surgery.
Fractures of the femoral neck or head. 3.
Avascular necrosis of the femoral head. 4.
Congenital dysplasia or other structural abnormalities where sufficient bone stock ട്. exists to properly seat the prosthesis.

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR
-------------------------------------------------	---	--------

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Michael Owens for MXM

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

510(k) Number K111936

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.