510(k) · Cleared
ClearedTitanium Versalok
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Mar 30, 1999 after a 26-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 30, 1999
- Review
- 26 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Versalok Screw Assembly Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
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?
A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (1.5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass. When not used as a pedicle screw fixation…
Read the full statement (252 words)
A construct with screws attached to the pedicles of the lumbar and sacral spine (L3 to S1) and autogenous bone graft may be used only for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the fifth lumbar - first sacral (1.5-S1) vertebral joint (see warnings below). The device is intended to be implanted using a posterior surgical approach and removed after the development of a solid fusion mass.
When not used as a pedicle screw fixation system, various combinations of the Titanium Versalok Screw Assembly components are also indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1) during bony fusion healing secondary to:
1. Unstable spinal fractures (such as fracture dislocations) or instability secondary to spinal tumors;
2. Degenerative disk diseases of the spine (defined as back pain of diskogenic origin with degeneration of the disk confirmed by radiographic studies);
3. Spinal curvatures (such as idiopathic scoliosis, neuromuscular scaliosis/kyphoscoliosis with associated paralysis or spasticity, and secondary to spinal fractures) which are:
» Progressive, despite other forms of treatment,
« Detrimental to cardiopulmonary function,
« Interfering with spinal mechanics or causing severe back pain,
or
« Cosmetically unacceptable, progressive, and painful.
The system is intended to provide temporary maintenance and support of the correction during the time normally needed for the fusion mass to mature. Use of spinal fixation instrumentation in children has been reported. Children should have adequate bony and soft tissue maturity to undergo implantation but need not have reached skeletal maturity.
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/K990708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990708: Titanium Versalok.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990708
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026