(370 days)
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No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for internal bone fixation for small bone fractures or osteotomies, which directly treats a medical condition.
No
The device description states it is "Used for angular correction of gaps and bony voids of small bones in the ankle and foot" and is intended for "internal bone fixation". Its function is to correct anatomical structures, not to identify or diagnose medical conditions.
No
The device description explicitly states it is an implant made of PEEK and Titanium alloy, which are hardware materials. The performance studies also describe physical testing of the device's mechanical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "internal bone fixation for small bone fractures or osteotomies in the ankle and foot." This describes a surgical implant used to treat a physical condition within the body.
- Device Description: The description details a physical implant made of PEEK and titanium, designed to facilitate bony integration and provide structural support.
- Function: The function is described as "Used for angular correction of gaps and bony voids of small bones in the ankle and foot," which is a mechanical function within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Adaptive Wedge is intended to be used for internal bone fixation for small bone fractures or osteotomies in the ankle and foot such as:
- Opening wedge osteotomies of Hallux Valgus
- Evans lengthening osteotomies .
- · Cotton osteotomy
This device is intended for use with ancillary fixation and is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Adaptive Wedge has a distinct design to help facilitate bony integration once implanted. It has angular teeth to prevent backing out. It is offered in 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
Not Found
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)
Non-clinical Test Summary:
The following tests were conducted:
- . Static compression testing
- . Dynamic compression testing
- . Determination of the coefficient of friction
- Determination of subsidence and debris generation during static and dynamic . compression-shear testing
The results of this testing indicate that the Adaptive Wedge is equivalent to predicate devices.
Clinical Test Summary
No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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