EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM

• K Number: K062775
• Device Name: EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
• Manufacturer: ORTHO DEVELOPMENT CORP.
• Date Cleared: 2007-01-16 ( 120 days)
• Product Code: LPH , LZO
• Regulation Number: 888.3358
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K043537 , K991485 , K921181 , K020580 , K921301 , K972228 , K020572 , K964218
• Predicate For: K131022 , K133386 , K141001 , K163585

Intended Use

The Ovation™ Hip Stem is used in uncemented total hip replacement in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
2. Previously failed surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. 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™ Hip Stem is a one-piece, tapered prosthesis, designed for single, uncemented use. Device fixation is achieved by an optimal press-fit in the medullary canal. The stem will be available in a variety of sizes to accommodate the majority of patients encountered with lengths of 110-165mm, horizontal offsets of 33-47mm, vertical offsets of 27-36mm, and neck angles of 127° and 132°. The stem is manufactured from Titanium Alloy (ASTM F-136, Ti-6A1-4V ELI) and the proximal portion of the stem is plasma sprayed with titanium alloy (ASTM F-1580). The finished stem is passivated per ASTM F-86.

AI/ML Overview

This is a 510(k) summary for a hip stem, which is a physical medical device, not an AI/ML device. Therefore, the typical acceptance criteria and study design for AI/ML devices (like those focusing on performance metrics such as sensitivity, specificity, or AUC based on expert ground truth) are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: For non-AI/ML medical devices like this hip stem, the "acceptance criteria" revolve around demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The specific criteria are often related to materials, design features, and mechanical performance as evaluated through engineering analysis and mechanical testing.
   • Reported Device Performance:
     • Material: Manufactured from Titanium Alloy (ASTM F-136, Ti-6A1-4V ELI); proximal portion plasma sprayed with titanium alloy (ASTM F-1580); finished stem passivated per ASTM F-86.
     • Design: One-piece, tapered prosthesis, designed for single, uncemented use with optimal press-fit. Available in various sizes (lengths: 110-165mm, horizontal offsets: 33-47mm, vertical offsets: 27-36mm, neck angles: 127° and 132°).
     • Performance (demonstrated through testing): "Engineering analysis and mechanical testing has demonstrated equivalence between the Ovation™ Hip Stem and the predicate devices." (Detailed results of these tests, such as fatigue strength, torsional stability, etc., are typically found in the full 510(k) submission, but only this summary statement is provided here.)

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Not applicable. This device is a physical implant, and the assessment is based on engineering principles and mechanical testing, not a "test set" of patient data or images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. "Ground truth" in the context of AI/ML or image analysis does not apply to this device. Material and mechanical properties are established through standardized testing procedures and industry specifications, not expert consensus on medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. There is no concept of "adjudication" for a physical device's mechanical or material properties.

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 physical hip stem, not an AI/ML diagnostic or assistive tool. Clinical testing was explicitly stated as "None provided" in the 510(k) summary.

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

   • Not applicable. There is no algorithm for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • The "ground truth" for this type of device is based on established engineering standards and material specifications (e.g., ASTM F-136 for Titanium Alloy, ASTM F-1580 for plasma spray, ASTM F-86 for passivation) and comparative mechanical testing against predicate devices. The equivalence is demonstrated through meeting these specified physical and mechanical properties.

8. The sample size for the training set

   • Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

   • Not applicable. No training set is used for this type of device.

Summary

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K062775

JAN 16 2007

Image /page/0/Picture/2 description: The image shows the logo for Ortho Development. The logo consists of a square with a stylized image of three curved lines above a circle on the left. To the right of the square is the text "ORTHO DEVELOPMENT" in a bold, sans-serif font. Below the company name is the tagline "engineering simplicity" in a smaller, italicized font.

Ortho Development Corporation
12187 S. Business Park Drive • Draper, Utah 84020
Phone [phone] • Fax [phone]
www.orthodevelopment.com

510(k) Summary

Date: January 8th, 2007

Applicant: Ortho Development Corporation

Contact Person: Ms. Johanne Young Quality Systems Engineer Ortho Development Corp. 12187 Business Park Drive Draper, Utah 84020 PH: 801-619-3450 FX: 801-619-8950 EM: [e-mail]

Proprietary Name: Ovation™ Hip Stem

Common Name: Hip Prosthesis, Uncemented Femoral Stem

Classification Names:

• 1. Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. (211 CFR 888.3358) (In accordance with 21 CFR 807.87(a)).
• 2. Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. (21 CFR 888.3353).

Legally Marketed Device To Which Substantial Equivalence Is Claimed:

K043537 - Taperloc® 12/14 Femoral Components (Biomet) K991485 - Synergy™ Porous Hip Stem (Smith & Nephew) K921181, K020580, K043537, K921301 - Mallory-Head® Total Hip System and Bi-Metric® Hip Femoral Components and Taperloc Femoral Stems (Biomet) K972228, K020572 - Meridian® Titanium Femoral Stems and Accolade TMZF® Femoral Stems (Howmedica) K964218 - Perfecta® Plasma Spray Hip Stems (Wright Medical)

Device Description: The Ovation™ Hip Stem is a one-piece, tapered prosthesis, designed for single, uncemented use. Device fixation is achieved by an optimal press-fit in the medullary canal. The stem will be available in a variety of sizes to accommodate the majority of patients

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510(k) Summary Ovation™ Hip Stem Ortho Development Corp.

encountered with lengths of 110-165mm, horizontal offsets of 33-47mm, vertical offsets of 27-36mm, and neck angles of 127° and 132°. The stem is manufactured from Titanium Alloy (ASTM F-136, Ti-6A1-4V ELI) and the proximal portion of the stem is plasma sprayed with titanium alloy (ASTM F-1580). The finished stem is passivated per ASTM F-86.

Intended Use: The Ovation™ Hip Stem is used in uncemented total hip replacement in cases of:

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

Summary Of Technologies: The overall design, materials and processing methods of the Ovation™ Hip Stem are similar to the predicate devices.

Non-Clinical Testing: Engineering analysis and mechanical testing has demonstrated equivalence between the Ovation™ Hip Stem and the predicate devices.

Clinical Testing: None provided

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ortho Development Corporation % Ms. Johanne Young 12187 South Business Park Drive Draper, Utah 84020

JAN 1 6 2007

Re: K062775

Trade/Device Name: Ovation™ 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, LZO Dated: December 20, 2006

Received: December 22, 2006

Dear Ms. Young:

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 such 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); 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.

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Page 2 - Ms. Johanne Young

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Saubare Bnehto

Mark N. Melkerson Dircctor Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K062775

Device Name: Ovation™ Hip Stem

Indications For Use:

The Ovation™ Hip Stem is used in non-cemented total hip replacement in cases of:

• 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• Previously failed surgery. 2.
• 3. Proximal femoral neck fractures or dislocation.
• 4. Idiopathic avascular necrosis of the femoral head.
• 5. Non-union of proximal femoral neck fractures.
• 6. Treatment of fractures that are unmanageable using other forms of therapy.
• 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

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)

Harbare Roceno

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number K062775

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.