(86 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for internal bone fixation for bone fractures or osteotomies, which is a therapeutic purpose.
No
The device is a wedge-shaped implant used for bone fixation and angular correction, not for diagnosis.
No
The device description explicitly states it is constructed from commercially pure titanium and is a series of wedge-shaped devices, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a physical implant (bone wedges) used for internal bone fixation during surgery. It is a device that is surgically placed within the body to treat bone fractures or deformities.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples or providing diagnostic information based on those samples. The device's function is purely structural and therapeutic.
Therefore, based on the provided information, the Integra® Titanium Bone Wedges are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- Evans lengthening osteotomies
The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.
The Integra® Titanium Bone Wedges are not intended for use in the spine.
Product codes
HRS, HWC
Device Description
The Integra® Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for angular correction of small bones in the ankle and foot. The Integra Titanium Bone Wedges are constructed from commercially pure titanium formed into a cancellous-like structure, and are offered in a variety of sizes and shapes to correct various skeletal deformities in the foot. The Integra® Titanium Bone Wedges are intended to be used with ancillary plating fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle and foot
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)
Mechanical testing, including expulsion, abrasion, static compression, and compressive fatigue, as well as biocompatibility testing were performed on the proposed device. The results of these verification activities demonstrate that the Integra Titanium Bone Wedges are safe for the intended use, and are substantially equivalent to the predicate device identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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510(K) SUMMARY
Integra® Titanium Bone Wedge
Submitter's name and address:
Ascension Orthopedics 8700 Cameron Road Austin, TX 78754 USA
Contact person and telephone number:
Kyla Kara Associate, Regulatory Affairs Telephone: 609.936.6926 Facsimile: 609.275.9445
AUG 07 2013
Date Summary was prepared:
May 9, 2013
Name of the device:
| Proprietary Name: | Integra® Titanium Bone Wedge |
|---|---|
| Common Name: | Bone Wedge |
| Classification Name: | Plate, Fixation, Bone (21CFR §888.3030, Product Code HRS) |
| Screw, Fixation, Bone (21CFR §888.3040, Product Code HWC) | |
| Classification Panel: | Orthopedic |
Substantial Equivalence:
The Integra® Titanium Bone Wedge is substantially equivalent in function and intended use to the predicate device detailed in the following table.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K093950 | HRS; HWC | BIOFOAM™ Bone | |
| Wedge | Wright Medical | ||
| Technology, Inc. |
Device Description:
The Integra® Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for angular correction of small bones in the ankle and foot. The Integra Titanium Bone Wedges are constructed from commercially pure titanium formed into a cancellous-like structure, and are offered in a variety of sizes and shapes to correct various skeletal deformities in the foot. The Integra® Titanium Bone Wedges are intended to be used with ancillary plating fixation.
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Indications for Use:
The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- · Evans lengthening osteotomies
The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.
The Integra® Titanium Bone Wedges are not intended for use in the spine.
Substantial Equivalence Comparison:
Components of the Integra Titanium Bone Wedge are similar in design and materials to the predicate device, BIOFOAM™ Bone Wedge (K093950).
Testing and Test Results:
Mechanical testing, including expulsion, abrasion, static compression, and compressive fatigue, as well as biocompatibility testing were performed on the proposed device. The results of these verification activities demonstrate that the Integra Titanium Bone Wedges are safe for the intended use, and are substantially equivalent to the predicate device identified.
Conclusion:
The design features, material, and intended use of the Integra® Titanium Bone Wedges are substantially equivalent to the predicate device. BIOFOAM™ Bone Wedge (K093950). The safety and effectiveness of the Integra® Titanium Bone Wedge is adequately supported by the substantial equivalence information, materials information, and performance data provided within this Premarket Notification submission.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present. The image is likely a header or title for a document or website related to the Department of Health & Human Services.
Public Ficalth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2013
Ascension Orthopedies Ms. Kyla Kara Associate, Regulatory Affairs 8700 Cameron Road Austin, Texas 78754
Re: K131360
Trade/Device Name: Integra® Titanium Bone Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: July 19, 2013 Received: July 22, 2013
Dear Ms. Kara:
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 cither 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 complics 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
Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus-like symbol with three parallel lines curving upwards, resembling a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
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Page 2 – Ms. Kyla Kara
device-related adverse events) (21 CFR 803); 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.
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.
Erin I. Keith
For
Mark N. Melkerson IDirector Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131360
Integra® Titanium Bone Wedge Device Name:
Indications For Use:
The Integra® Titanium Bone Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as:
· Cotton (opening wedge) osteotomies of the medial cuneiform
· Evans lengthening osteotomies
The Integra® Titanium Bone Wedges are intended for use with ancillary plating fixation.
The Integra Titanium Bone Wedges are not intended for use in the spine.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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
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