(142 days)
Not Found
No
The device description is for a system of small bone screws, which are mechanical devices. There is no mention of software, image processing, AI, ML, or any data-driven components.
Yes
The device is used for internal fixation following trauma or reconstruction, which are therapeutic interventions.
No
The device description indicates that it is a system of screws intended for internal fixation of small bones, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "system of small bone screws," which are physical hardware components used for internal fixation. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "a system of small bone screws." These are physical implants used in surgery.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples.
The information provided clearly indicates a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction.
Product codes
Not Found
Device Description
This submission describes a system of small bone screws. Screws are available in diameters ranging from 0.8 to 2.4 mm and lengths ranging from 2 mm to 28 mm. These devices are for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones including the craniomaxillofacial skeleton
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)
K761228, K882454, K913355, K935448, K854886, K862482, K961485
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
FEB - 6 1997
510(k) Summary
| Device Proprietary Name: | Leibinger® - Luhr® Small Craniomaxillofacial
Bone Screw System |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Small Bone Screws |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation
Appliances and Accessories 888.3030 |
| Name of Submitter: | Howmedica Leibinger Inc. |
| Contact Person (s): | Andrew B. Rogers
Director, Product Development and Special Projects
Howmedica Leibinger Inc.
14540 Beltwood Pkwy. East
Dallas, TX 75244
Telephone: (214) 392-3636 x233
Fax: (214) 392-7258 |
| | Kristyn R. Waski
Product Engineer, Special Projects
Howmedica Leibinger Inc.
14540 Beltwood Pkwy. East
Dallas, TX 75244
Telephone: (214) 392-3636 x266
Fax: (214) 392-7258 |
Date Prepared:
September 12, 1996
Summary:
This submission describes a system of small bone screws. It is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction. Screws are available in diameters ranging from 0.8 to 2.4 mm and lengths ranging from 2 mm to 28 mm. These devices are for single use only.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Howmedica Luhr® Fixation System (K761228,K882454. K913355, K935448); the Wurzburg® Bone Screws (K854886); the Steinhauser® Bone Screws (K862482) and the Howmedica Leibinger Forefoot Reconstruction System (K961485). The Luhr", Wurzburg and Steinhauser , and Forefoot bone screws are intended for use as small bone screws in internal fixation procedures. The Forefoot screws are manufactured from Ti6A14V. The basic operational principle is similar for each of these devices.