(83 days)
Not Found
Not Found
No
The document describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is intended to assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops, which qualifies it as a therapeutic device.
No
The device, the LIBERTY™ Anterior Spinal System, is an implantable system of rods, screws, connectors, and staples intended to assist in temporarily stabilizing the spine. Its indications for use are related to specific spinal conditions and not for diagnostic purposes.
No
The device description explicitly lists physical implant components made of stainless steel and titanium alloy, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "Anterior Spinal System" intended to "assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description details implant components like rods, screws, connectors, and staples made from materials like stainless steel and titanium. These are all components of a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided text does not mention any such use or components.
Therefore, the LIBERTY™ Anterior Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIBERTY" Anterior Spinal System is intended to assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops. The specific indications for the LIBERTY™ Anterior Spinal System are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
- Pseudoarthrosis
- Stenosis
- Spondylolisthesis
- Spinal deformities: scoliosis, lordosis, kyphosis
- Fracture
- Unsuccessful previous attempts at spinal fusion
- Tumor resection
All components of the LIBERTY™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.
WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
Not Found
Device Description
The LIBERTY" Anterior Spinal System consists of the following implants components: Rods (LIBERTY Rods, TSRH Rods, CD HORIZON Knurled Rod, CD HORIZON Rod), Screws (LIBERTY Closed Screws-5.5mm, 6.5mm, 7.5mm diameter; LIBERTY Closed Screws-6.5mm, 7.5mm diameter; LIBERTY Closed Screw w/10° Oblique Canal-6.5mm, 7.5mm diameter; LIBERTY Closed Screw w/15° Oblique Canal-6.5mm, 7.5mm diameter; LIBERTY Open Screw-5.5mm, 6.5mm, 7.5mm diameter), Connectors and Cross Connectors (LIBERTY 12-32 Break-Off Set Screw, LIBERTY Open Implant Closure Saddle, TSRH Single Hole Staples, TSRH Two Hole Offset Staples, Left and Right, TSRH Washer, TSRH Low Profile CROSSLINK Offset Plate, TSRH Low Profile CROSSLINK Plate, 0.625 in length, TSRH Low Profile CROSSLINK Plate Set).
The implant components are fabricated from ASTM F138 (or its ISO equivalent) stainless steel or from ASTM F136 (or its ISO equivalent) titanium alloy. In addition, one of the CD HORIZON spinal rods which may be used with the LIBERTY™ Anterior Spinal System and the TSRH® Single Hole Anterior Staples are fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. Titanium implants are not to be used with stainless steel implant components in a spinal construct. A LIBERTY anterior construct may involve either a single rod or two rods. The implant components may be sold sterile or non-sterile. Instrumentation is also available to facilitate implantation of the device components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or lumbar spine
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)
Mechanical test data were supplied or referenced in support of the LIBERTY" Anterior Spinal System 510(k) notification. The LIBERTY" Anterior Spinal System was declared to be substantially equivalent to other commercially available devices.
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.
Not Found
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
Not Found
§ 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.
0
LIBERTY™ Anterior Spinal System 510(k) Summary K965193 MAR 1 7 1997
March, 1997
- Sofamor Danek USA Company: 1. 1800 Pyramid Place Memphis, TN 38132 901-396-3133
Proprietary Trade Name: LIBERTY™ Anterior Spinal System ll.
Spinal intervertebral body fixation orthosis. Classification Name:
- The LIBERTY" Anterior Spinal System consists of the following implants III. components:
| Component | Stainless
Steel | Titanium
Alloy | Commercially
Pure Titanium |
|--------------------------------------------------------|--------------------|-------------------|-------------------------------|
| Rods: | | | |
| LIBERTY™ Rods, 6.35mm diameter | ✓ | ✓ | |
| TSRH® Rods, 6.35mm diameter | ✓ | ✓ | |
| CD HORIZON™ Knurled Rod, 6.35mm
diameter | | ✓ | |
| CD HORIZON™ Rod, 6.35mm diameter | | | ✓ |
| Screws: | | | |
| LIBERTY™ Closed Screws-5.5mm, 6.5mm,
7.5mm diameter | ✓ | | |
| LIBERTY™ Closed Screws-6.5mm, 7.5mm
diameter | | ✓ | |
| LIBERTY™ Closed Screw w/10° Oblique | ✓ | | |
| Canal-6.5mm, 7.5mm diameter | | | |
| LIBERTY™ Closed Screw w/15° Oblique | ✓ | | |
| Canal-6.5mm, 7.5mm diameter | | | |
| LIBERTY™ Open Screw-5.5mm, 6.5mm,
7.5mm diameter | ✓ | | |
| Connectors and Cross Connectors: | | | |
| LIBERTY™ 12-32 Break-Off Set Screw | ✓ | ✓ | |
| LIBERTY™ Open Implant Closure Saddle | ✓ | | ✓ |
| TSRH® Single Hole Staples | ✓ | ✓ | |
| TSRH® Two Hole Offset Staples, Left and
Right | ✓ | ✓ | |
| TSRH® Washer | ✓ | ✓ | |
| TSRH® Low Profile CROSSLINK® Offset
Plate | ✓ | ✓ | |
| TSRH® Low Profile CROSSLINK® Plate,
0.625 in length | ✓ | ✓ | |
| TSRH® Low Profile CROSSLINK® Plate Set | ✓ | ✓ | |
1
The LIBERTY" Anterior Spinal System implant components are fabricated from ASTM F138 (or its ISO equivalent) stainless steel or from ASTM F136 (or its ISO equivalent) titanium alloy. In addition, one of the CD HORIZON spinal rods which may be used with the LIBERTY™ Anterior Spinal System and the TSRH® Single Hole Anterior Staples are fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. Titanium implants are not to be used with stainless steel implant components in a spinal construct A LIBERTY anterior construct may involve either a single rod or two rods. The implant components may be sold sterile or non-sterile. Instrumentation is also available to facilitate implantation of the device components.
- The LIBERTY" Anterior Spinal System is intended to assist in temporarily IV. stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops. The specific indications for the LIBERTY™ Anterior Spinal System are the following:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
-
- Pseudoarthrosis
-
- Stenosis
-
- Spondylolisthesis
- Spinal deformities: scoliosis, lordosis, kyphosis မွာ
-
- Fracture
-
- Unsuccessful previous attempts at spinal fusion
- Tumor resection ಹ
-
All components of the LIBERTY™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.
WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
- Mechanical test data were supplied or referenced in support of the V. LIBERTY" Anterior Spinal System 510(k) notification. The LIBERTY" Anterior Spinal System was declared to be substantially equivalent to other commercially available devices.
© 1997 Sofamor Danek