The Ovation 10/12 Hip Stem is intended for use in a total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

The Ovation 10/12 Hip Stem is indicated for use in uncemented total hip arthroplasty procedures in cases of:

Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
Previously failed hip surgery.
Proximal femoral neck fractures or dislocation.
Idiopathic avascular necrosis of femoral head.
Non-union of proximal femoral neck fractures.
Treatment of fractures that are unmanageable using other forms of therapy.
Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Device Description

The Ovation 10/12 Hip Stem is a one-piece press-fit tapered femoral stem, designed for single, uncemented use. The system consists of a variety of sizes to accommodate the majority of patients encountered, lengths (98-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.

The Ovation 10/12 Hip Stem has a rectangular cross-section and provides stability through a 3point fixation. The femoral stem is manufactured from Titanium Alloy (ASTM F-136, Ti-6Al-4V ELI). The proximal portion of the stem is plasma-sprayed with titanium alloy (ASTM F-1580).

AI/ML Overview

The provided text describes the regulatory clearance for the Ovation 10/12 Hip Stem, which is a medical device (hip prosthesis), not an AI/ML clinical decision support tool. Therefore, much of the requested information (e.g., sample sizes for test/training sets, adjudication methods, MRMC studies, ground truth establishment by experts, AI performance metrics) is not applicable to this type of device and is not present in the document.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, manufacturing, intended use, and most importantly, mechanical performance through physical testing.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

ODEV Protocol/Report Number	ISO Standard(s)	Test Type	Acceptance Criteria (Implied by "Pass")	Test Results (Pass/Fail)
P-10-0017	ISO 7206-6:1992(E)	Proximal Fatigue	Met requirements of ISO 7206-6:1992(E)	Pass
P-13-0065	ISO 7206-4:2010(E)	Distal Fatigue	Met requirements of ISO 7206-4:2010(E)	Pass
R-13-0062A	ISO 21535:2007(E)	Range of Motion	Met requirements of ISO 21535:2007(E)	Pass

Note: For physical devices, "acceptance criteria" are typically defined by the performance requirements outlined in the referenced ISO standards. A "Pass" result indicates that the device met these criteria.

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

Test Set Sample Size: The document specifies "Size 1 Ovation 10/12 Hip Stem EXT (100-1001)" for the fatigue tests. This indicates that a specific size/model of the hip stem was tested. The exact number of samples tested for each fatigue and range of motion test is not explicitly stated, but it would typically involve a small number of physical prototypes (e.g., n=3 or n=5) to demonstrate compliance with the mechanical standards.
Data Provenance: The data comes from internal testing conducted by Ortho Development Corporation, likely in a laboratory setting according to the specified ISO standards. It is not patient data (retrospective or prospective) from a country of origin.

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

Not Applicable. This is a physical device. "Ground truth" in the context of AI/ML models (e.g., image annotation by radiologists) does not apply here. The "ground truth" for mechanical testing is adherence to the specified ISO standard requirements under laboratory conditions.

4. Adjudication Method for the Test Set

Not Applicable. See point 3. Testing is conducted according to a standard protocol, and results are objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a physical orthopedic implant. MRMC studies are relevant for diagnostic devices or AI tools that assist human interpretation.

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

Not Applicable. This is a physical device, not an algorithm. The mechanical tests (fatigue, range of motion) are standalone performance evaluations of the device itself.

7. The Type of Ground Truth Used

Mechanical Performance Standards. The "ground truth" is defined by the performance parameters and acceptance limits specified in the referenced ISO standards (ISO 7206-6, ISO 7206-4, ISO 21535). These are objective, quantifiable criteria for the physical properties of the implant.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not a machine learning model that requires a training set. The design of the device is based on engineering principles and existing knowledge of hip prostheses, not on "training data."

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

Not Applicable. See point 8.

Summary

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K131022

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Section 5 510(k) Summary

Name of Sponsor:	Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020	OCT 16 2013
510(k) Contact:	Tom HaueterRegulatory Affairs ManagerTelephone: (801) 553-9991Facsimile: (801) 553-9993Email: thaueter@orthodevelopment.com
Date Prepared:	March 27, 2013
Trade Name:	Ovation 10/12 Hip Stem
Common Name:	Hip Stem Prosthesis
Classification:	21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis, Class II device
Device Product Code:	LPH
Predicate Devices:	Ovation® Hip Stem, Ortho Development (K062775)Taperloc® Hip Stem, Biomet Orthopedics (K043537)Anthology® Hip Stem, Smith & Nephew (K052792)Titanium Tri-Lock® Hip Stem, DePuy Orthopedics (K010367)

5.1. Device Description:

Page 1 of 2

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Section 5 510(k) Summary

5.2. Intended Use:

5.3. Indications for Use:

The Ovation 10/12 Hip Stem is indicated for use in uncemented total hip arthroplasty procedures in cases of:

Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic 1. arthritis.
1. Previously failed hip surgery.
Proximal femoral neck fractures or dislocation. 3.
1. Idiopathic avascular necrosis of femoral head.
ບ່ Non-union of proximal femoral neck fractures.
ర్. Treatment of fractures that are unmanageable using other forms of therapy.
Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities 7. where sufficient bone stock exists to properly seat the prosthesis.

5.4. Basis of Substantial Equivalence:

The Ovation 10/12 Hip Stem is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical performance.

In accordance with ISO standards, proximal and distal fatigue tests were performed on the worst-case Ovation 10/12 Hip Stem to determine the stem's endurance performance. Further, a range of motion analysis was also performed. A summary of tests performed, results, and standards used is given below in Table 5.1.

ODEVProtocol/ReportNumber	ISO Standard(s)	Test Type	Test Specimen(s)	Test Results(Pass/Fail)
P-10-0017	ISO 7206-6:1992(E)	ProximalFatigue	Size 1 Ovation 10/12 HipStem EXT (100-1001)	Pass
P-13-0065	ISO 7206-4:2010(E)	DistalFatigue	Size 1 Ovation 10/12 HipStem EXT (100-1001)	Pass
R-13-0062A	ISO 21535:2007(E)	Range ofMotion	Ovation 10/12 Hip Stem	Pass

Table 5.1: Testing Summary for Ovation 10/12 Hip Stem

Ovation 10/12 Hip Stem 510(k)

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

October 16, 2013

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

Re: K131022

Trade/Device Name: Ovation 10/12 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 Dated: September 3, 2013 Received: September 6, 2013

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, 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

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Page 2 - Mr. Tom Haueter

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Erinfiy Meith

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications for Use Statement

510(k) Number (if known): K131022

Device Name: Ovation 10/12 Hip Stem

Indications for Use:

The Ovation 10/12 Hip Stem is indicated for use in uncemented total hip arthroplasty procedures in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
1. Previously failed hip surgery.
1. Proximal femoral neck fractures or dislocation.
1. Idiopathic avascular necrosis of femoral head.
1. Non-union of proximal femoral neck fractures.
1. Treatment of fractures that are unmanageable using other forms of therapy.
Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities 7. where sufficient bone stock exists to properly seat the prosthesis.

Prescription Use X (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)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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.