# K964254: Titanium Liberty Posterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Apr 21, 1997 after 179 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K980928: Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System (1998), 0 descendants of its own

## Indications for 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). Pseudoarthrosis Stenosis Spondylolisthesis Spinal deformities: scoliosis, kyphosis, and lordosis Fracture Unsuccessful previous attempts at spinal fusion 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 non-cervical 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.

Source page: https://510kreport.com/device/K964254
Methodology: https://510kreport.com/methodology