(21 days)
Not Found
Not Found
No
The summary describes a physical bone wedge made of titanium foam and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as an internal bone fixation device for bone fractures, fusions, or osteotomies in the ankle and foot, which are therapeutic interventions.
No
The device description indicates that the BIOFOAM™ Bone Wedge is a physical implant (titanium metal foam wedge) used for internal bone fixation and angular correction, not for identifying or diagnosing a condition.
No
The device description clearly states it is a "titanium metal foam wedge," indicating it is a physical hardware device, not software.
Based on the provided information, the BIOFOAM™ Bone Wedge 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.
- BIOFOAM™ Bone Wedge Function: The description clearly states that the BIOFOAM™ Bone Wedge is a titanium metal foam wedge used for internal bone fixation during surgical procedures (fractures, fusions, osteotomies). It is a physical implant used within the body to provide structural support.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the BIOFOAM™ Bone Wedge falls under the category of a surgical implant or device used for structural support and fixation, not an in vitro diagnostic test.
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
The BIOFOAM™ Bone Wedge is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
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 in one distinct design with varying widths and thicknesses to accommodate a variety of small bone applications.
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)
Not Found
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.
Not Found
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
§ 888.3030 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
K073535 i of d
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS JAN - 7 2008
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 BIOFOAM™ Bone Wedge.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | November 19, 2007 |
| Contact Person: | Brian Young |
| Sr. Director, Regulatory Affairs | |
| Proprietary Name: | BIOFOAM TM Bone Wedge |
| Common Name: | Bone Wedge |
| Classification Name and Reference: | 21 CFR 888.3040/ HWC Smooth or threaded metallic bone fixation fastener - Class II |
| 21 CFR 888.3030/ HRS Single/multiple component metallic bone fixation appliances and accessories - Class II | |
| Device Product Code and Panel Code: | Orthopedics/87/HWC & Orthopedics/87/HRS |
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
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 in one distinct design with varying widths and thicknesses to accommodate a variety of small bone applications.
1
Ki735535 pg Rct 2
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the BIOFOAM™ Bone Wedge are substantially equivalent to the previously 510(k) cleared Small Bone Wedge. The safety and effectiveness of the BIOFOAM™ Bone Wedge is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The logo is black and white.
Public Health Service
JAN - 7 2008
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Wright Medical Technologies, Inc. % Mr. Brian Young 5677 Airline Road Arlington, TN 38002
K073535 Re: 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: November 19, 2007 Received: December 17, 2007
Dear Mr. 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.
3
Page 2 - Mr. Brian 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mikkelson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
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.
The BIOFOAM™ Bone Wedge is 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)
1 of 1
Kourence A. Clay FOR M.MELKERSON
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K073535 510(k) Number