(117 days)
Not Found
No
The summary describes a bone plate for internal fixation and focuses on mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
No
The device is a bone plate used for internal fixation of the distal fibula, which is a structural support device rather than one that treats or cures a disease or condition.
No
The device is described as a bone plate for internal fixation, which is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is adding "bone plates" with a different geometry, which are physical hardware components used for internal fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "internal fixation of the distal fibula." This describes a surgical procedure to stabilize a bone fracture, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a bone plate, which is an implantable medical device used in surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The VariAx " Fibula Straight Plates are intended for use in internal fixation of the distal fibula.
Product codes
87 HRS
Device Description
This 510(k) submission is intended to add bone plates with a different geometry to the VariAx " fibular plate line which was cleared in K081284. The new plates are termed "Fibula Straight Plates" and consist of the shaft portion of the cleared plate plus an oblong screw hole in some configurations. Additionally, other fixation plates (predicates) have been cleared with the approximate plate length of the subject device, including the Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal fibula
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
Fatigue strength verification and stiffness analysis were evaluated by way of a 4-point bending test. Median fatigue limits and stiffness of the subject VariAxTM Fibula Straight Plates were found equivalent to the existing fibula plates in the predicate system, Synthes One-Third Tubular Dynamic Compression Locking plates. The data presented demonstrates substantial equivalence to the predicate devices.
Key Metrics
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.
0
K102282
pg 1 of 2
510(k) Summary of Safety and Effectiveness: VariAx" Locked Plating System Line Extension for Addition of Fibula Straight Plates
DEC - 7 2010
| Submission Information | |
|---|---|
| Name and Address of the Sponsor | |
| of the 510(k) Submission: | Howmedica Osteonics Corp |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| For Information contact: | Stephanie M. Fitts, Director Regulatory |
| Affairs and Regulatory Compliance | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5405 | |
| Fax: (201) 831-4405 | |
| Date Summary Prepared: | November 29, 2010 |
| Device Identification | |
| Proprietary Name: | VariAxTM Locked Plating System Line |
| Extension for addition of Fibula Straight | |
| Plates | |
| Common Name: | Bone plates and screws |
| Classification Name and Reference: | Single/multiple component metallic bone |
| fixation appliances and accessories, 21 CFR | |
| §888.3030 | |
| Device Product Code: | 87 HRS: Plate, Fixation, Bone |
Description:
This 510(k) submission is intended to add bone plates with a different geometry to the VariAx " fibular plate line which was cleared in K081284. The new plates are termed "Fibula Straight Plates" and consist of the shaft portion of the cleared plate plus an oblong screw hole in some configurations. Additionally, other fixation plates (predicates) have been cleared with the approximate plate length of the subject device, including the Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335).
Intended Use:
The VariAx " Fibula Locked Plating System Line Extension addition of Fibula Straight Plates does not alter the intended use of the predicate system as cleared in K081284. The indications for use for the subject plates are provided below.
Indications for Use:
The VariAx " Fibula Straight Plates are intended for use in internal fixation of the distal fibula.
1
Statement of Technological Comparison:
The subject and predicate devices are made from Titanium Grade 2 with type II anodization. Fatigue strength verification and stiffness analysis were evaluated by way of a 4-point bending test. Median fatigue limits and stiffness of the subject VariAxTM Fibula Straight Plates were found equivalent to the existing fibula plates in the predicate system, Synthes One-Third Tubular Dynamic Compression Locking plates. The data presented demonstrates substantial equivalence to the predicate devices.