(66 days)
Not Found
No
The device description and intended use describe a mechanical cable system for surgical fixation, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is indicated for medical conditions such as spinal trauma and deformities (scoliosis, lordosis), as well as trauma to various joints, which are all conditions that would typically be addressed by a therapeutic device. It is used for correction and reattachment, indicating a direct therapeutic purpose rather than just diagnosis.
No
The device, the Osteonics Silkon Stainless Steel Cable System, is described as a system of cables and crimps used for spinal trauma, correction of deformities, and reattachment in various anatomical sites. Its "Intended Use / Indications for Use" section focuses on treatment and structural support rather than diagnosing conditions or identifying diseases. There is no mention of it performing any diagnostic functions like analyzing images, detecting biomarkers, or assessing physiological parameters for diagnostic purposes.
No
The device description explicitly states it consists of stainless steel cables and crimps, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device being used in vivo (within the body) for surgical procedures related to spinal trauma, deformities, and trauma to various joints and the sternum. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information about a person's health.
- Device Description: The device is a surgical cable system made of stainless steel, designed for implantation or fixation within the body. This is consistent with a surgical implant or fixation device, not an IVD.
- Lack of IVD-related information: There is no mention of analyzing biological specimens, diagnostic purposes, or any of the typical components or processes associated with IVDs.
Therefore, the Osteonics Silkon" Stainless Steel Cable System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Osteonics Silkon" Stainless Steel Cable System is indicated for cervical, thoracic and lumbar spinal trauma and/or the correction of scoliosis, and lordosis deformities. The Osteonics" Silkon" Stainless Steel Cable System is also indicated for trochanteric reattachment. sternotomy indications, and trauma to the shoulder, elbow, hip, knee and ankle.
Product codes
Not Found
Device Description
The Osteonics" Silkon" Stainless Steel Cable System consists of two designs: a single, multistrand, stainless steel cable with an individual monofilament wire leader and a stainless steel crimp; or one multi-strand, stainless steel, double cable with a monofilament Y-Leader and two stainless steel crimps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracic and lumbar spinal, trochanteric, sternotomy, shoulder, elbow, hip, knee and ankle.
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)
As the components of the Osteonics" Silkon" Stainless Steel Cable System remain identical to those of the predicate AME Silkon" Cable System, which has been determined substantially equivalent via 510(k) Premarket Notification #K932687, no additional performance data is deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
K96 2132
AUG - 8 1996
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics* Silkon™ Stainless Steel Cable System
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Osteonics Corporation
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Chuck Ryan
Regulatory Affairs Team Leader |
| Date of Summary Preparation: | August 2, 1996 |
| Device Identification | |
| Proprietary Name: | Osteonics® Silkon™ Stainless Steel Cable System,
which includes the following components: |
| | - Osteonics® Silkon™ Stainless Steel Single Cable
- Osteonics® Silkon™ Stainless Steel Y Cable
- Osteonics® Silkon™ Stainless Steel Crimp |
| Common Name: | Cerclage Fixation Components |
| Classification Name/Reference: | Bone Fixation Cerclage
21 CFR §888.3010 |
Overview:
The purpose of this 510(k) premarket notification is to address the addition of a sterile offering of this system.
Predicate Device Identification:
The components of the Osteonics Silkon" Stainless Steel Cable System are substantially
1
Osteonics® Silkon Stainless Steel Cable System
equivalent to those of the AME Silkon" Cable System, which was determined substantially equivalent by the U.S. Food and Drug Administration (FDA) via 510(k) Premarket Notification #K932687.
Description of Devices:
The Osteonics" Silkon" Stainless Steel Cable System consists of two designs: a single, multistrand, stainless steel cable with an individual monofilament wire leader and a stainless steel crimp; or one multi-strand, stainless steel, double cable with a monofilament Y-Leader and two stainless steel crimps.
Intended Use:
The Osteonics Silkon" Stainless Steel Cable System is indicated for cervical, thoracic and lumbar spinal trauma and/or the correction of scoliosis, and lordosis deformities. The Osteonics" Silkon" Stainless Steel Cable System is also indicated for trochanteric reattachment. sternotomy indications, and trauma to the shoulder, elbow, hip, knee and ankle.
Statement of Technological Comparison:
The designs and stainless steel material characterizing the components of the Osteonics Silkon" Stainless Steel Cable System are identical to those of the predicate AME Silkon" Cable System.
Performance Data:
As the components of the Osteonics" Silkon" Stainless Steel Cable System remain identical to those of the predicate AME Silkon" Cable System, which has been determined substantially equivalent via 510(k) Premarket Notification #K932687, no additional performance data is deemed necessary.