510(k) · Cleared
ClearedRogozinski Thoracolumbar Spinal Rod
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 Mar 11, 1996 after a 151-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.
- Decided
- Mar 11, 1996
- Review
- 151 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 3 citing it directly.
- This deviceK954696 Rogozinski Thoracolumbar Spinal RodSmith & Nephew Richards, Inc. · 1996
- Descendant · cites it directly · 21 of its ownK150417 Astra Spine SystemSpinecraft, LLC · 2015
- Descendant · 2 generations on · 12 of its ownK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
- Descendant · 2 generations on · 8 of its ownK223273 ASTRA Spine SystemSpinecraft, LLC · 2022
- Descendant · 2 generations on · 6 of its ownK162786 PASS LP Spinal SystemMedicrea International SA · 2017
- Descendant · 3 generations on · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K150417Astra Spine SystemSpinecraft, LLC · 2015 · cites it directly21descendants
- K211323ASTRA Spine SystemSpinecraft, LLC · 2021 · 2 generations on12descendants
- K223273ASTRA Spine SystemSpinecraft, LLC · 2022 · 2 generations on8descendants
- K162786PASS LP Spinal SystemMedicrea International SA · 2017 · 2 generations on6descendants
- K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954696 | Rogozinski Thoracolumbar Spinal Rod | Smith & Nephew Richards, Inc. | 1996 | — |
| +1 | K150417 | Astra Spine System | Spinecraft, LLC | 2015 | — |
| +2 | K211323 | ASTRA Spine System | Spinecraft, LLC | 2021 | — |
| +2 | K223273 | ASTRA Spine System | Spinecraft, LLC | 2022 | — |
| +2 | K162786 | PASS LP Spinal System | Medicrea International SA | 2017 | — |
| +3 | K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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? (10)
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 |
|---|---|---|---|
| * | — | Harrington “Lag” Screw Named without a submission number | |
| * | — | ISOLA® Spinal System Named without a submission number | |
| * | — | CD Spinal System Named without a submission number | |
| * | — | GDLH™ Posterior Spinal System Named without a submission number | |
| * | — | TSRH™ Spinal System Named without a submission number | |
| * | — | Paragon™ Posterior Spinal System Named without a submission number | |
| * | — | Unit Rod System Named without a submission number | |
| * | — | MOSS™ Modular Segmental Spinal Instrumentation System Named without a submission number | |
| * | — | Modulock™ Posterior Spinal Fixation System Named without a submission number | |
| * | — | Wiltse System of Internal Fixation Named without a submission number |
What descends from it? (24)
See all 243 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, K150417 (Spinecraft, LLC, 2015) has gone furthest, with 21 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?
Posterior pedicle screw fixation: The Rogozinski Thoracolumbar Spinal Rod System Direct ("U"-shaped head) and Offset ("T"-shaped head) screws when placed in the pedicles of vertebral levels L3 to S1 ar¢ intended cnly 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; and (c) who are having the device fixed or…
Read the full statement (172 words)
Posterior pedicle screw fixation: The Rogozinski Thoracolumbar Spinal Rod System Direct ("U"-shaped head) and Offset ("T"-shaped head) screws when placed in the pedicles of vertebral levels L3 to S1 ar¢ intended cnly 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; and (c) who are having the device fixed or attached to the lumbar and sacral spine. Otherwise, the Direct and Offset Screws are intended only for sacral/iliac attachment as specified below.
Posterior hook and/or sacraliiliac screw fixation: The Rogozinski [horacolumbar Spinal Rod System is intended for the treatment of degenerative disc disease (defined as spinal instability and one or more of the following: decreased disc height, ridging of vertebral end plates, osteophyte formation, scarring or thickening of ligamentous tissues and/or changes in facet joint morphology); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; unsuccessful previous attempts at spinal fusion; or turnor resection. The Rogozinski Thoracolumbar Spinal Rod system is limited to non-cervical use.
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/K954696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954696: Rogozinski Thoracolumbar Spinal Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954696
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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