← Product Code [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH) · K131022 # OVATION 10/12 HIP STEM (K131022) _Ortho Development Corp. · LPH · Oct 16, 2013 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K131022 ## Device Facts - **Applicant:** Ortho Development Corp. - **Product Code:** [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH.md) - **Decision Date:** Oct 16, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3358 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use 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. ## Device Story The Ovation 10/12 Hip Stem is a one-piece, press-fit, tapered femoral prosthesis for uncemented total hip arthroplasty. It features a rectangular cross-section designed for 3-point fixation to provide stability. The device is available in various sizes, lengths (98-142mm), and offsets to accommodate patient anatomy. It is implanted by an orthopedic surgeon during total hip replacement surgery to replace a damaged hip joint, aiming to increase patient mobility and reduce pain. The device relies on mechanical fixation within the femoral canal; it does not involve electronic or software-based components. ## Clinical Evidence Bench testing only. No clinical data provided. Testing included proximal fatigue (ISO 7206-6:1992(E)), distal fatigue (ISO 7206-4:2010(E)), and range of motion analysis (ISO 21535:2007(E)) on worst-case test specimens, all of which passed. ## Technological Characteristics Material: Titanium Alloy (ASTM F-136, Ti-6Al-4V ELI). Proximal surface: Plasma-sprayed titanium alloy (ASTM F-1580). Design: One-piece, press-fit, tapered femoral stem with rectangular cross-section. Geometry: 130° resection angle, 132° neck angle. Fixation: Uncemented, 3-point fixation. No energy source, software, or connectivity. ## Regulatory 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. ## Predicate Devices - Ovation® Hip Stem, Ortho Development ([K062775](/device/K062775.md)) - Taperloc® Hip Stem, Biomet Orthopedics ([K043537](/device/K043537.md)) - Anthology® Hip Stem, Smith & Nephew ([K052792](/device/K052792.md)) - Titanium Tri-Lock® Hip Stem, DePuy Orthopedics ([K010367](/device/K010367.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ ## K131022 ### Page 1 of 2 ## Section 5 510(k) Summary | Name of Sponsor: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 | OCT 16 2013 | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | 510(k) Contact: | Tom Haueter
Regulatory Affairs Manager
Telephone: (801) 553-9991
Facsimile: (801) 553-9993
Email: 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-constrained
porous-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: 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). Page 1 of 2 {1}------------------------------------------------ # Section 5 510(k) Summary #### 5.2. Intended Use: 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. #### 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. - 2. Previously failed hip surgery. - Proximal femoral neck fractures or dislocation. 3. - 4. 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. | ODEV
Protocol/Report
Number | ISO Standard(s) | Test Type | Test Specimen(s) | Test Results
(Pass/Fail) | |-----------------------------------|--------------------|---------------------|-------------------------------------------------|-----------------------------| | P-10-0017 | ISO 7206-6:1992(E) | Proximal
Fatigue | Size 1 Ovation 10/12 Hip
Stem EXT (100-1001) | Pass | | P-13-0065 | ISO 7206-4:2010(E) | Distal
Fatigue | Size 1 Ovation 10/12 Hip
Stem EXT (100-1001) | Pass | | R-13-0062A | ISO 21535:2007(E) | Range of
Motion | Ovation 10/12 Hip Stem | Pass | ## Table 5.1: Testing Summary for Ovation 10/12 Hip Stem Ovation 10/12 Hip Stem 510(k) {2}------------------------------------------------ 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 {3}------------------------------------------------ ## 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 {4}------------------------------------------------ # 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. - 2. Previously failed hip surgery. - 3. Proximal femoral neck fractures or dislocation. - 4. Idiopathic avascular necrosis of femoral head. - 5. Non-union of proximal femoral neck fractures. - 6. 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K131022](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K131022) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com