K Number
K964416
Device Name
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
Manufacturer
Date Cleared
1997-03-17

(164 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SYNTHES (USA) Universal Spinal Parallel Connector is part of the Universal Rod and Screw Fixation System and is intended for anterolateral screw/staple fixation for the correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine, (levels T8-L5).
Device Description
The Synthes Universal Spinal Rod and Screw Fixation System consists of rods, and 6, 7, and 8 mm diameter side-opening screws with a collar and nut. The system also includes a staple, a washer and a parallel connector. The Universal Spinal side-opening screws attach to the anterolateral portion of the vertebral body of the thoracolumbar spine (levels T8-L5) and are connected via a rod. The Synthes Universal Spinal Rod and Screw Fixation System Parallel Connector is provided non-sterile: moist heat sterilization is recommended.
More Information

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No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.

No
The device is a component of a spinal fixation system intended to correct deformities, pseudoarthrosis, and fractures; it is an implantable mechanical support device, not a device that provides therapy.

No

The device description indicates that the SYNTHES (USA) Universal Spinal Parallel Connector is part of a fixation system, including rods and screws, intended for surgical correction of spinal deformities and injuries. It is an implantable surgical hardware, not a device used to identify, measure, or monitor a medical condition.

No

The device description clearly states it consists of rods, screws, staples, washers, and a parallel connector, which are all 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Description: The provided description clearly states that the SYNTHES Universal Spinal Parallel Connector is part of a system used for fixation within the spine. It is an implantable device used to mechanically stabilize the spine.
  • Intended Use: The intended use is for the correction of deformities, pseudoarthrosis, and fracture or dislocation of the spine. This is a surgical intervention, not a diagnostic test performed on a specimen.

The device is a surgical implant used for structural support and stabilization within the body, which is the opposite of an in vitro diagnostic.

N/A

Intended Use / Indications for Use

The SYNTHES (USA) Universal Spinal Parallel Connector is part of the Universal Rod and Screw Fixation System and is intended for anterolateral screw/staple fixation for the correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine, (levels T8-L5).

Product codes (comma separated list FDA assigned to the subject device)

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Device Description

The Synthes Universal Spinal Rod and Screw Fixation System consists of rods, and 6, 7, and 8 mm diameter side-opening screws with a collar and nut. The system also includes a staple, a washer and a parallel connector. The Universal Spinal side-opening screws attach to the anterolateral portion of the vertebral body of the thoracolumbar spine (levels T8-L5) and are connected via a rod.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

thoracolumbar spine, (levels T8-L5)

Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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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.

The Acromed Kaneda SR (Smooth Rod) Anterior Spinal System

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).

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§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.

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Attachment D:

K9644)6

ss Information Summary of Safety and Effectivene 510(k) Summary

SYNTHES (U.S.A.) l 690 Russell Road Paoli, PA 19301

MAR 1 7 1997

(610) 647-9700 Contact: Angela Silvestri

Device:

SYNTHES (U.S.A.) Universal Spinal Rod, and Screw Fixation System Parallel Connector compared to the Acromed Kaneda SR (Smooth Rod) Anterior Spinal System Transverse Couplers.

The Synthes Universal Spinal Rod and Screw Fixation System consists of rods, and 6, 7, and 8 mm diameter side-opening screws with a collar and nut. The system also includes a staple, a washer and a parallel connector. The Universal Spinal side-opening screws attach to the anterolateral portion of the vertebral body of the thoracolumbar spine (levels T8-L5) and are connected via a rod.

The SYNTHES (USA) Universal Spinal Parallel Connector is part of the Universal Rod and Screw Fixation System and is intended for anterolateral screw/staple fixation for the correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine, (levels T8-L5).

The Acromed Kaneda SR (Smooth Rod) Anterior Spinal System has the same intended use and is also indicated for correction of anterolateral lordotic deformities of the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of thoracolumbar fractures like the Universal Spinal Parallel Connector.

The Acromed Kaneda SR (Smooth Rod) Anterior Spinal is manufactured from certified Implant Grade stainless steel and a titanium alloy (Ti-6A1-4V). This system is similar in component dimensions and sizes to the SYNTHES (U.S.A.) Universal Spinal Parallel Connector.

The Synthes Universal Spinal Rod and Screw Fixation System Parallel Connector is provided non-sterile: moist heat sterilization is recommended.

Based on the above, the SYNTHES (U.S.A.) Universal Spinal Parallel Connector is substantially equivalent to Acromed Kaneda SR (Smooth Rod) Anterior Spinal System.