510(k) · Cleared
ClearedEmpower Anterior Direct Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on May 8, 1997 after a 129-day review. The FDA summary names no predicate by number. 30 later devices descend from it.
- Decided
- May 8, 1997
- Review
- 129 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 2 citing it directly.
- This deviceK965224 Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
- Descendant · cites it directly · 27 of its ownK983904 Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998
- Descendant · 2 generations on · 14 of its ownK031595 U & I America Spinal Hook SystemU&I Corp., America · 2003 · Recalled
- Descendant · 2 generations on · 9 of its ownK100757 Tilock Pedicle Screw SystemGenesys Spine · 2010 · Recalled
- Descendant · 3 generations on · 8 of its ownK103671 Genesys Spine Tilock SystemGenesys Spine · 2011
- Descendant · 3 generations on · 7 of its ownK152039 Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K983904Rogozinski Spinal Rod SystemUnited States Surgical, A Division of Tyco Healthc · 1998 · cites it directly27descendants
- K031595U & I America Spinal Hook SystemU&I Corp., America · 2003 · 2 generations on14descendants
- K100757Tilock Pedicle Screw SystemGenesys Spine · 2010 · 2 generations on9descendants
- K103671Genesys Spine Tilock SystemGenesys Spine · 2011 · 3 generations on8descendants
- K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine · 2015 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965224 | Empower Anterior Direct Screws | Smith & Nephew Richards, Inc. | 1997 | — |
| +1 | K983904 | Rogozinski Spinal Rod System | United States Surgical, A Division of Tyco Healthc | 1998 | — |
| +2 | K031595 | U & I America Spinal Hook System | U&I Corp., America | 2003 | 3 |
| +2 | K100757 | Tilock Pedicle Screw System | Genesys Spine | 2010 | 1 |
| +3 | K103671 | Genesys Spine Tilock System | Genesys Spine | 2011 | — |
| +3 | K152039 | Genesys Spine TiLock2 Spinal System | Genesys Spine | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (30)
See all 302 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K983904 (United States Surgical, A Division of Tyco Healthc, 1998) has gone furthest, with 27 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 Thorocolumbar Spinal System consists of single use devices designed to aid in the surgical correction of several types of spinal conditions by providing stabilization until a solid spinal fusion develops. When used as a pedicle screw system, the Thorocolumbar Spinal System when used in constructs with screws or spinal bolts placed in the pedicle are intended only for: grades 3 or 4 spondylolisthesis at the fifth lumbar-first sacral vertebral (L5-S1)…
Read the full statement (230 words)
The Thorocolumbar Spinal System consists of single use devices designed to aid in the surgical correction of several types of spinal conditions by providing stabilization until a solid spinal fusion develops.
When used as a pedicle screw system, the Thorocolumbar Spinal System when used in constructs with screws or spinal bolts placed in the pedicle are intended only for: grades 3 or 4 spondylolisthesis at the fifth lumbar-first sacral vertebral (L5-S1) joint: who are receiving fusion using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of solid fusion.
When used as a posterior hook and sacral/iliac screw fixation system only, the Thorocolumbar Spinal System is indicated for:
Scoliotic, lordotic, or kyphotic deformities
ddd ((defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
pseudarthrosis
stenosis
spondylolisthesis (grade 1 or 2)
fracture
tumor resection
As a posterior system, it is limited to non-cervical posterior use with the levels of posterior screw fixation from L3-S1.
As an anterolateral spinal system the indications are for anterior stabilization of levels T10 to L5 of the spine following: degenerative disc disease (defined above), tumor resection, spondylolisthesis, spondylolysis, fracture, pseudoarthrosis, and multi-operated back; and to correct lordotic and kyphotic spinal deformities.
The levels of anterolateral use are T10-LS5.
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/K965224 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965224: Empower Anterior Direct Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965224
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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