(127 days)
None
No
The device description is for a system of small bone screws, which are mechanical implants and do not inherently incorporate AI/ML. The summary does not mention any AI/ML related terms or functionalities.
Yes
This device is an implantable screw used for internal fixation of small bones, which is a therapeutic intervention for trauma or reconstruction.
No
Explanation: The device is described as a system of small bone screws intended for internal fixation, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it is a system of small bone screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states the device is a system of small bone screws intended for internal fixation of bones. This is a surgical implant used within the body, not for testing samples outside the body.
- Intended Use: The intended use is for "internal fixation of small bones... secondary to trauma or for reconstruction." This is a therapeutic and structural purpose, not a diagnostic one.
The information provided aligns with a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
This submission describes a system of small bone screws. It is intended for use in internal fixation of small bones including the hand and foot secondary to trauma or for reconstruction.
Product codes
Not Found
Device Description
Screws are available in diameters ranging from 0.8 to 3.5 mm and lengths ranging from 2 mm to 40 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 hand 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
Not Found
Key Metrics
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K96 3739
510(k) Summary JAN 22 1997
Device Proprietary Name: Leibinger^(H) - Luhr^(H) Small Orthopedic
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 hand and foot secondary to trauma or for reconstruction. Screws are available in diameters ranging from 0.8 to 3.5 mm and lengths ranging from 2 mm to 40 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 Lune , Wurzburg and Steinhauser , Profyle 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.