(298 days)
Not Found
No
The description focuses on the material and physical characteristics of a bone wedge implant and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
A therapeutic device actively treats or cures a condition. This device is a bone wedge used for fixation or angular correction in bone surgeries, acting as an implant rather than a device delivering therapy.
No
The device is an implantable bone wedge used for surgical procedures (internal bone fractures, fusions, or osteotomies) in the ankle and foot, not for diagnosing conditions.
No
The device description clearly states it is a "titanium metal foam implant," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BIOFOAM® Bone Wedge Function: The description clearly states that the BIOFOAM® Bone Wedge is a titanium metal foam implant used for internal bone fractures, fusions, or osteotomies in the ankle and foot. It is a physical implant used to support and correct bone structure.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is entirely mechanical and structural within the body.
The information provided describes a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The BIOFOAM® Bone Wedge is intended to be used for internal bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- · Cotton and Evans Wedges:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Metatarsal/Cuneiform arthrodesis
- · Midfoot Wedges:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
- Subtalar Implant:
- Hindfoot Arthrodesis
This device is intended for use with ancillary fixation. 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 implant used for angular correction of small bones of the foot. It is offered 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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Fatigue testing was provided to support the substantial equivalence of the subject device. The safety and effectiveness of the BIOFOAM® Bone Wedge is adequately supported by testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification.
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.
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
Image /page/0/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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Incorporated Val Mvles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
May 17, 2016
Re: K152062 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: Class II Product Code: HRS, HWC Dated: April 14, 2016 Received: April 15, 2016
Dear Val Myles:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152062
Device Name
BIOFOAM® Bone Wedge
Indications for Use (Describe)
The BIOFOAM® Bone Wedge is intended to be used for internal bone fractures, fusions, or osteotomies in the ankle and foot, such as:
- · Cotton and Evans Wedges:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Metatarsal/Cuneiform arthrodesis
- · Midfoot Wedges:
- · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
- · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
- Subtalar Implant:
- Hindfoot Arthrodesis
This device is intended for use with ancillary fixation. The BIOFOAM® Bone Wedge is not intended for use in the spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 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.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Headquarters Wright Medical Technology, Inc.
Memphis TN 38117
01867997
510(K) SUMMARY
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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the BIOFOAM® Bone Wedge.
| (a)(1). Submitted By: | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
|---|---|
| Date: | April 14, 2016 |
| Contact Person: | Val Myles Regulatory Affairs Specialist Office - (901) 290-5162 Fax – (901) 867-4190 |
| (a)(2). Proprietary Name: | BIOFOAM® Bone Wedge |
| Common Name: | Bone Wedge |
| Classification Name and Reference: | 21 CFR 888.3030 - Class II |
| Device Product Code, Device Panel: | HRS, HWC |
| (a)(3). Predicate Device: | K070525: CHARLOTTE® 7.0 MUC Screw and Washer K142724: BIOFOAM® Bone Wedge |
(a)(4). Device Description
The BIOFOAM® Bone Wedge is a titanium metal foam implant used for angular correction of small bones of the foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.
(a)(5). 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:
- · Cotton and Evans Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- · Opening wedge of Medial Cuneiform or Cotton osteotomies
- · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
- · Metatarsal/Cuneiform arthrodesis
4
- Midfoot Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
- Subtalar Implant:
- Hindfoot Arthrodesis
This device is intended for use with ancillary fixation. The BIOFOAM Bone Wedge is not intended for use in the spine.
(a)(6). Technological Characteristics Comparison
The BIOFOAM® Bone Wedge and the legally marketed predicate devices have similar indications and materials. The subject device includes the addition of a Subtalar wedge and is technologically substantially equivalent to the predicate devices.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Fatigue testing was provided to support the substantial equivalence of the subject device. The safety and effectiveness of the BIOFOAM® Bone Wedge is adequately supported by testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.