510(k) · Cleared
ClearedTitanium Liberty Posterior Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Danek USA,Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Apr 21, 1997 after a 179-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Apr 21, 1997
- Review
- 179 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK964254 Titanium Liberty Posterior Spinal SystemSofamor Danek USA,Inc. · 1997
- Descendant · cites it directly · 0 of its ownK980928 Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw…Synthes Spine · 1998
Most influential descendants
Showing 1 of 1 · See all- K980928Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation SystemSynthes Spine · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964254 | Titanium Liberty Posterior Spinal System | Sofamor Danek USA,Inc. | 1997 | — |
| +1 | K980928 | Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System | Synthes Spine | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980928 | Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K980928 (Synthes Spine, 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (364 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964254 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964254: Titanium Liberty Posterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964254
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026