(126 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a hip stem prosthesis, with no mention of AI or ML technology.
Yes.
The device is a hip implant intended to provide increased patient mobility and decrease pain by replacing a damaged hip joint, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a hip stem intended for total hip replacement surgery. It is an implant designed to replace a damaged hip joint, not to diagnose a condition.
No
The device description clearly states it is a physical implant (hip stem) made of titanium alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip replacement surgery, which is a surgical procedure to replace a damaged hip joint. This is a treatment, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant (hip stem) made of titanium alloy, designed to be surgically inserted into the bone. This is a medical device, not a reagent, instrument, or system used for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Ovation Tribute and Ovation Narrow Hip Stems are 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.
Indications for Use (Describe)
- Notably impaired hip joint due to ostcoarthritis, theumatoid arthrilis 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 unnanageable using other forms of therapy.
- Benign or malignant bone tumors, congenital denormalities where sufficient bone stock exists to properly seat the prosthesis.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The Ovation Tribute and Ovation Narrow Hip Stems are one-piece, tapered prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stems are manufactured from titanium alloy Tì-6Al-4V ELI per ASTM F136. Proximally, the stems are coated with titanium plasma spray per ASTM F1580. The stems have a neck with a 12/14 trunnion taper for modular attachment to femoral heads. To accommodate varying patient anatomy, the stems are available in a variety of sizes: lengths (74-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing has been conducted in accordance with ISO 7206-6:1992 and distal fatigue in accordance with ISO 7206-4:2010. Range of motion analysis was performed per ISO 21535:2007(E). The plasma spray coating underwent testing for mechanical properties and microstructure analysis. No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K062775, K131022, K110400, K103256
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K133386
ﻧﺰ
Section 5 510(k) Summary
MAR 1 1 2014
| NAME OF SPONSOR: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Mike Ensign
Director of Regulatory Affairs and Quality Assurance
Telephone: (801) 553-9991
Facsimile: (801) 553-9993
Email: mensign@odev.com |
| DATE PREPARED: | October 28, 2013 |
| PROPRIETARY NAME: | Ovation Tribute Hip Stem
Ovation Narrow Hip Stem |
| COMMON NAME: | Hip Stem Prosthesis |
| CLASSIFICATION: | Class II device
21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis |
| DEVICE PRODUCT CODE: | LPH |
| PREDICATE DEVICES: | Ovation® Hip Stem, Ortho Development (K062775)
Ovation 10/12 Hip Stem, Ortho Development (K131022)
Taperloc® Complete Microplasty System, Biomet (K110400)
Smith & Nephew SMF Hip Stem, Smith & Nephew (K103256) |
5.1. Device Description
The Ovation Tribute and Ovation Narrow Hip Stems are one-piece, tapered prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stems are manufactured from titanium alloy Tì-6Al-4V ELI per ASTM F136. Proximally, the stems are coated with titanium plasma spray per ASTM F1580. The stems have a neck with a 12/14 trunnion taper for modular attachment to femoral heads. To accommodate varying patient anatomy, the stems are available in a variety of sizes: lengths (74-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.
Section 5, 510(k) Summary
1
5.2. Intended Use
The Ovation Tribute and Ovation Narrow Hip Stems are 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
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic 1. 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 7. where sufficient bone stock exists to properly seat the prosthesis.
Summary of Technological Characteristics 5.4.
The Ovation Tribute and Ovation Narrow Hip Stems represent an update to the existing predicate device Ovation® Hip Stem (K062775). The Ovation Tribute and Ovation Narrow Hip Stems combine the design features of the Ovation® Hip Stem (K062775) with a narrowed distal body to accommodate varying patient anatomy. Additionally, the Ovation Tribute stem features a reduced overall length in order to provide a microplasty option. The Ovation Tribute and Ovation Narrow Hip Stems have the same technological characteristics as the predicate devices. These include:
- . Intended use (as described above)
- . Basic design
- . Material
- . Sizes
.
Therefore, the fundamental scientific technology of Ovation Tribute and Ovation Narrow Hip Stems is the same as previously cleared devices.
5.5. Basis of Substantial Equivalence
The Ovation Tribute and Ovation Narrow Hip Stems are substantially equivalent to the previously cleared predicate devices based on similarities in intended use, overall design, materials, manufacturing methods, packaging, mechanical performance, and sterilization.
2
Non-Clinical Test Summary 5.6.
Non-clinical performance testing has been conducted in accordance with ISO 7206-6:1992 and distal fatigue in accordance with ISO 7206-4:2010. Range of motion analysis was performed per ISO 21535:2007(E). The plasma spray coating underwent testing for mechanical properties and microstructure analysis.
5.7. Clinical Test Summary
No clinical studies were performed.
5.8. Conclusions
Based on the similarities to the predicate devices, and a review of the testing, the devices are substantially equivalent to femoral stem components that were cleared under K062775, K131022, K110400, and K103256.
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2014
Ortho Development Corporation Mr. Mike Ensign Director of Quality Assurance/Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020
Re: K133386
Trade/Device Name: Ovation Tribute Hip Stem; Ovation Narrow 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: January 28, 2014 Received: January 29, 2014
Dear Mr. Ensign:
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
4
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wigqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K133386
Device Name
Ovation Tribute Hip Stem; Ovation Narrow Hip Stem
Indications for Use (Describe)
-
Notably impaired hip joint due to ostcoarthritis, theumatoid arthrilis 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 unnanageable using other forms of therapy.
-
Benign or malignant bone tumors, congenital denormalities where sufficient bone stock exists to properly seat the prosthesis.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Parl 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE BORNEY CONTRACT PORTEDA USE ONLY CORPOR FOR FOR THE CONTRACT CONTRACT CONTRACTOR CONTRACTOR C
Concurrence of Center for Devices and Radlological Health (CDRH) (Signalure)
Elizabeth₪ gank -S
Division of Orthopedic Devices
FORM FDA 3881 (9/13)
PSC Tok Schip Sortives (30) } 41 624)