(30 days)
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Not Found
No
The summary describes a physical bone wedge made of titanium foam and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an internal bone fixation device for bone fractures, fusions, or osteotomies in the ankle and foot, which is a structural support device, not a therapeutic agent.
No
The device, BIOFOAM® Bone Wedge, is described as intended for internal bone fixation for fractures, fusions, or osteotomies. Its function is to provide structural support and correction, not to diagnose medical conditions.
No
The device description explicitly states it is a "titanium metal foam wedge," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used in vitro (outside the body).
- The BIOFOAM® Bone Wedge is a surgical implant used for internal bone fixation within the body. It is used in vivo.
The description clearly states its intended use is for surgical procedures on bones in the ankle and foot. This is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The BIOFOAM® Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- · Opening wedge osteotomies of Hallux Valgus
- · Evans lengthening osteotomies
- · Metatarsal/cuneiform arthrodesis
This device is intended for use with ancillary fixation.
The BIOFOAM® Bone Wedge is not intended for use in the spine.
Product codes
HRS, HWC
Device Description
The BIOFOAM® Bone Wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
ankle and foot
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the BIOFOAM® Bone Wedge are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the BIOFOAM® Bone Wedge.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | January 22, 2010 |
| Contact Person: | Kellen Hills |
| Regulatory Affairs Specialist | |
| Proprietary Name: | BIOFOAM® Bone Wedge |
| Common Name: | Bone Wedge |
| Classification Name and Reference: | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HRS/HWC |
DEVICE INFORMATION
A. INTENDED USE
The BIOFOAM® Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- · Opening wedge osteotomies of Hallux Valgus
- · Evans lengthening osteotomies
- · Metatarsal/cuneiform arthrodesis
This device is intended for use with ancillary fixation.
The BIOFOAM® Bone Wedge is not intended for use in the spine.
B. DEVICE DESCRIPTION
The BIOFOAM® Bone Wedge is a titanium metal foam wedge used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features of the BIOFOAM® Bone Wedge are substantially equivalent to the design features of the predicate identified in this 510(k) submission. The safety and effectiveness of the BIOFOAM® Bone Wedge are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this 510(k).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 22 2010
Wright Medical Technology, Inc. % Mr. Kellen Hills 5677 Airline Road Arlington, Tennessee 38002
Re: K093950
Trade/Device Name: BIOFOAM Bone Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC
Dated: December 21, 2009 Received: December 23, 2009
Dear Mr. Hills:
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 Mav 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 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 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 - Mr. Kellen Hills
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Survcillance.
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 vours.
Barbara Buell
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K043 95 0
Device Name: BIOFOAM® Bone Wedge
Indications For Use:
The BIOFOAM® Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as:
· Opening wedge osteotomies of Hallux Valgus
· Evans lengthening osteotomies
- · Metatarsal/cuneiform arthrodesis
This device is intended for use with ancillary fixation.
The BIOFOAM® Bone Wedge is not intended for use in the spine.
Prescription Use XXX (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)
Quietti for MXn
Division of Surgical Orthopedic,
and Restorative Devices
510(k) Number K093950
Concurrence of CDRH, Office of Device Evaluation (ODE)
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