(42 days)
Not Found
No
The device description and intended use clearly describe a mechanical implant (screws) used to lock intramedullary rods. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as screws used to lock intramedullary rods in position, indicating a mechanical function rather than a therapeutic one (i.e., treating or curing a disease/condition directly).
No
Explanation: The device is described as screws used to lock intramedullary rods in position, which is a therapeutic rather than a diagnostic function. There is no mention of it collecting or analyzing data for diagnosis.
No
The device description explicitly states the screws are manufactured from a Titanium alloy and are available in different diameters and lengths, indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with intramedullary rod systems and are used to lock the IM rods in position after placement in the femoral canal. This is a surgical implant used within the body, not a device used to test samples outside the body.
The information provided describes a surgical implant used for orthopedic procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/ Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal.
Product codes
HSB
Device Description
The fully threaded screws are manufactured from a Titanium alloy and are available in 5.0mm and 3.7mm diameters in lengths of 25 to 100mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral canal
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)
K850441, K922266, K926232, K935295, K960524, K884500, K890936, K954554
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
1963398
OCT 10 1996 510(k) Summary
Proprietary Name: Alta® Fully Threaded Cross-Locking Screws
Common Name: Intramedullary Fixation Rod
Classification Name and Reference: 21 CFR 888.3020 Intramedullary Fixation Rod
Proposed Regulatory Class: Class II
Device Product Code: OR(87) HSB
ﺳﺴﻪ
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 8/29/96
The Alta® Fully Threaded Cross-Locking Screws are intended to be used in conjunction with the Alta® Femoral and Alta® Tibial/ Humeral Intramedullary Rod Systems. Specifically, the screws are used to lock the IM rods in position after placement in the femoral canal.
The fully threaded screws are manufactured from a Titanium alloy and are available in 5.0mm and 3.7mm diameters in lengths of 25 to 100mm.
The substantial equivalence of these screws is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's Alta® Femoral Locking IM Rod System (K850441 & K922266), Alta® CFx Reconstruction Rod System (K926232, K935295 & K960524), and Alta® Tibial/Humeral IM Rod System (K884500, K890936 & K954554); Biomet's Uniflex Tibial Nail System and Retrograde Femoral Nail System; and Zimmer's ZMS Intramedullary Recon Nail.