(142 days)
No
The 510(k) summary describes a mechanical orthopedic implant system and makes no mention of AI or ML technology. The device description focuses on the physical components and their intended use in fracture stabilization.
Yes
The device is used for the "temporary stabilization of fractures," which directly addresses and treats a medical condition.
No
The device is described as a system for temporary stabilization of fractures, indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it consists of physical components like lag screws, sideplates, and a compression screw, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "temporary stabilization of fractures of the proximal femur... and/or distal third of the femur". This describes a surgical implant used to treat bone fractures within the body.
- Device Description: The device consists of "lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw". These are all components used in orthopedic surgery.
- Anatomical Site: The anatomical site is the "proximal femur... and/or distal third of the femur". This refers to bones within the body.
In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. The Omega+ Compression Screw System does not perform any such tests on samples. It is a physical implant used to stabilize bone fractures.
N/A
Intended Use / Indications for Use
The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released under K850886, K872223, K922295, and K930156. These components are now made available in sterile packaging. It is Howmedica's intention to market these products both sterile and non-sterile.
Product codes
KTT, OR
Device Description
The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released under K850886, K872223, K922295, and K930156. These components are now made available in sterile packaging. It is Howmedica's intention to market these products both sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area)
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)
K850886, K872223, K922295, K930156
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
455306
510 (k) Summary of Safety and Effectiveness
Proprietary Name: Omega+ Compression Screw System APR - 8 199 Common Name: Compression Screw System Classification Name and Reference: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories Proposed Regulatory Class: Class II Device Product Code: KTT OR ( 87 ) For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica 359 Veterans Boulevard Rutherford, New Jersey 07070 Telephone: (201) 507-7431 Fax: (201) 507-6870
The Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released
under K850886, K872223, K922295, and K930156. These components are now made available in sterile packaging. It is Howmedica's intention to market these products both sterile and non-sterile.
Date Summary Prepared: 11-9-95
Directions for one recommended sterilization technique are included in the labeling for the device. There is no change in intended use, design, material, method of manufacture, or surgical technique for the device.