K Number

Device Name

TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM

Manufacturer

SOFAMOR DANEK USA,INC.

Date Cleared

1997-04-21

(179 days)

Product Code

KWP

Regulation Number

888.3050

Intended Use

The LIBERTY" Posterior Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. Except for situations using pedicle screws in patients, (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the LIBERTY" Posterior Spinal System are the following: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). 2. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, and lordosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection The LIBERTY" Posterior Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The LIBERTY™ Posterior Spinal System is limited to noncervical use. The LIBERTY" Screws and TSRH® Variable Angle Screws, when used as pedicle screws with the LIBERTY" Posterior Spinal System, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and not lower than the sacrum. Otherwise the LIBERTY" screws and TSRH® Variable Angle Screws, when used with the LIBERTY™ Posterior Spinal System, are intended for sacral/iliac attachment only. The CCD" Screws for Sacral Block are intended for sacral/iliac attachment only. All of the CD HORIZON" and LIBERTY" hooks are intended for thoracic and/or lumbar attachment only. TSRH® CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, and CCD Transverse links, domino, and cylinder are intended for posterior thoracic, lumbar, and/or sacral use only.

Device Description

The LIBERTY" Posterior Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors and connecting components. The LIBERTY™ Posterior Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or its ISO equivalent. Alternatively, the LIBERTY" Posterior Spinal System may be made from titanium alloy as described by such standards as ASTM F136 or its ISO equivalent. Do not use stainless steel and titanium implant components in the same construct. Sofamor Danek expressly warrants that these devices are fabricated from the foregoing material specifications. No other warranties, expressed, or implied, are made. The LIBERTY" Posterior Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components comprising the LIBERTY™ Posterior Spinal System and those from other Sofamor Danek spinal systems which can be used with the LIBERTY™ Posterior Spinal System are listed in the following table.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

Yes.
The device is intended to provide temporary stabilization and help augment the development of a solid spinal fusion, which are therapeutic functions.

Diagnostic

The LIBERTY™ Posterior Spinal System is described as an implantable device intended to provide temporary stabilization and augment spinal fusion. It consists of rods, hooks, screws, and connectors, all designed for surgical implantation to treat various spinal conditions, not to diagnose them.

SaMD (Software as a Medical Device)

The device description explicitly states that the LIBERTY" Posterior Spinal System consists of physical components like rods, hooks, screws, cross connectors, and connecting components made from medical grade stainless steel or titanium alloy. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The description clearly states that the LIBERTY™ Posterior Spinal System is an implantable device consisting of rods, hooks, screws, and connecting components. Its intended use is to provide temporary stabilization and augment spinal fusion in the thoracic, lumbar, and sacral spine. This is a surgical implant, not a device that analyzes biological samples.

The text focuses on the physical components of the device, its surgical application, and the anatomical locations where it is used. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The LIBERTY" Posterior Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The LIBERTY™ Posterior Spinal System is limited to noncervical use. The LIBERTY" Screws and TSRH® Variable Angle Screws, when used as pedicle screws with the LIBERTY" Posterior Spinal System, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and not lower than the sacrum. Otherwise the LIBERTY" screws and TSRH® Variable Angle Screws, when used with the LIBERTY™ Posterior Spinal System, are intended for sacral/iliac attachment only. The CCD" Screws for Sacral Block are intended for sacral/iliac attachment only. All of the CD HORIZON" and LIBERTY" hooks are intended for thoracic and/or lumbar attachment only. TSRH® CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, and CCD Transverse links, domino, and cylinder are intended for posterior thoracic, lumbar, and/or sacral use only.

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

Not Found

Device Description

Stainless Steel

LIBERTY™ Knurled Rods, 0.250" Diameter LIBERTY™ Hooks LIBERTY" Closed Screws, 5.5mm, 6.5mm, and 7.5mm Diameters LIBERTY" Closed Screws with Oblique Canal, 6.5mm and 7.5mm Diameters LIBERTY" Open Screws, 5.5mm. 6.5mm. and 7.5mm Diameters LIBERTY™ Lateral Connectors LIBERTY" Set Screw and Closure Saddle TSRH® Flex Hex-End Rod, 0.250" Diameter, L=4cm-20cm TSRH® Flex Hex-End Rod, 0.250" Diameter, L=20" TSRH® Rigid Hex-End Rod, 0.250" Diameter, L=20 TSRH® Super Flex Hex-End Rod, 0.250" Diameter, L=20" TSRH® Variable Angle Screws, 5.5mm, 6.5mm, 7.5mm Diameters TSRH® Top Tightening Variable Angle T-Bolts TSRH® CROSSLINK® PLATES. L=0.625"-1.125" TSRH® CROSSLINK® MULTI-SPAN Piates, L=1.25"-3.75" TSRH® CROSSLINK® Offset Plates (Left and Right), L=0.375" and 0.500" TSRH® CROSSLINK® AXIAL Plate TSRH® Low Profile CROSSLINK® Offset Plate, L=0.375" TSRH® Low Profile CROSSLINK® Plates, L=0.625"-2.000" TSRH® Fixed CROSSLINK® Plate, L=1.2"-2.7" TSRH® CROSSLINK® Eyebolt, 1/4", Open and Closed TSRH® CROSSLINK® Plate Locknuts CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates TSRH® and CD HORIZON™ CROSSLINK® Set Screws CCD™ Transverse link assembly with 60 mm bar CCD™ Transverse link assembly with 120 mm bar CCD™ Transverse link bar length 60 mm CCD™ Transverse link bar length 120 mm CCD™ Transverse link hook CCD™ Chopin sacral block, left CCD™ Chopin sacral block, right CCD™ Chopin iliac extension CCD™ Screws for sacral blocks, lengths 30 mm to 80 mm in 5 mm increments CCD" Domino with closed body, diameter 7 mm CCD™ Cylinder, Diameter 7 mm

Titanium Alloy

LIBERTY" Closed Screws, 6.5mm and 7.5mm Diameters

LIBERTY™ Breakoff Set Screw

TSRH® Spinal Rod, 0.250" Diameter

CD HORIZON™ Hooks

CD HORIZON™ Breakoff Set Screw

TSRH® Variable Angle Screws, 6.5 mm and 7.5 mm Diameters TSRH® Top Tightening Variable Angle T-Bolts TSRH® Low Profile CROSSLINK® Offset Plate, L=0.375" TSRH® Low PROFILE CROSSLINK® Plates, L=0.625"-1.750 CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates TSRH® and CD HORIZON™ CROSSLINK® Plate Set Screws

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic, lumbar, and/or sacral levels of the posterior 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 in support of this 510(k) notification.

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.

Summary

APR 21 1997

LIBERTY" Posterior Spinal System 510 kt Summary K964254 January, 1997

1. Sofamor Danek USA Company: 1800 Pyramid Place Memphis. TN 38132 901-396-3133

Proprietary Trade Name: LIBERTY™ Posterior Spinal System 11.

Pedicle Screw Fixation - Spondylolisthesis spinal fixation Classification Name: Otherwise, spinal interlaminal fixation device system. orthosis.

The LIBERTY" Posterior Spinal System consists of a variety of shapes and sizes of 111. rods, hooks, screws, cross connectors and connecting components. The LIBERTY™ Posterior Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or its ISO equivalent. Alternatively, the LIBERTY" Posterior Spinal System may be made from titanium alloy as described by such standards as ASTM F136 or its ISO equivalent. Do not use stainless steel and titanium implant components in the same construct. Sofamor Danek expressly warrants that these devices are fabricated from the foregoing material specifications. No other warranties, expressed, or implied, are made.
The LIBERTY" Posterior Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components comprising the LIBERTY™ Posterior Spinal System and those from other Sofamor Danek spinal systems which can be used with the LIBERTY™ Posterior Spinal System are listed in the following table.

Stainless Steel

TSRH® Rigid Hex-End Rod, 0.250" Diameter, L=20 TSRH® Super Flex Hex-End Rod, 0.250" Diameter, L=20" TSRH® Variable Angle Screws, 5.5mm, 6.5mm, 7.5mm Diameters TSRH® Top Tightening Variable Angle T-Bolts TSRH® CROSSLINK® PLATES. L=0.625"-1.125" TSRH® CROSSLINK® MULTI-SPAN Piates, L=1.25"-3.75" TSRH® CROSSLINK® Offset Plates (Left and Right), L=0.375" and 0.500" TSRH® CROSSLINK® AXIAL Plate TSRH® Low Profile CROSSLINK® Offset Plate, L=0.375" TSRH® Low Profile CROSSLINK® Plates, L=0.625"-2.000" TSRH® Fixed CROSSLINK® Plate, L=1.2"-2.7" TSRH® CROSSLINK® Eyebolt, 1/4", Open and Closed TSRH® CROSSLINK® Plate Locknuts CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates TSRH® and CD HORIZON™ CROSSLINK® Set Screws CCD™ Transverse link assembly with 60 mm bar CCD™ Transverse link assembly with 120 mm bar CCD™ Transverse link bar length 60 mm CCD™ Transverse link bar length 120 mm CCD™ Transverse link hook CCD™ Chopin sacral block, left CCD™ Chopin sacral block, right CCD™ Chopin iliac extension CCD™ Screws for sacral blocks, lengths 30 mm to 80 mm in 5 mm increments CCD" Domino with closed body, diameter 7 mm CCD™ Cylinder, Diameter 7 mm

Titanium Alloy

LIBERTY" Closed Screws, 6.5mm and 7.5mm Diameters

LIBERTY™ Breakoff Set Screw

TSRH® Spinal Rod, 0.250" Diameter

CD HORIZON™ Hooks

CD HORIZON™ Breakoff Set Screw

The LIBERTY" Posterior Spinal System is intended to provide temporary stabilization IV. and to help augment the development of a solid spinal fusion. Except for situations using pedicle screws in patients, (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the LIBERTY" Posterior Spinal System are the following:
- 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
- 1. Pseudoarthrosis
- 1. Stenosis
- 1. Spondylolisthesis
- 1. Spinal deformities: scoliosis, kyphosis, and lordosis
- 1. Fracture
- 1. Unsuccessful previous attempts at spinal fusion
- 1. Tumor resection

This 510(k) notification apprised the FDA of the addition of titanium alloy implant V. components to the system, as well as the use of several stainless steel components from other cleared Sofamor Danek systems with stainless steel LIBERTY™ components.
VI. Mechanical test data were supplied in support of this 510(k) notification. The LIBERTY" Posterior Spinal System was declared to be substantially equivalent to several commercially available devices.