510(k) · Cleared
ClearedLTD Polyaxial Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Spinal Technologies, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 8, 2004 after an 85-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK041625 LTD Polyaxial Fixation SystemUs Spinal Technologies, LLC · 2004
- Descendant · cites it directly · 3 of its ownK081296 Preference Pedicle Screw SystemUs Spine · 2008
- Descendant · 2 generations on · 2 of its ownK081883 Modification to Preference Pedicle Screw SystemUs Spine · 2008
- Descendant · 3 generations on · 1 of its ownK162160 Preference Elite Pedicle Screw SystemAmedica Corporation · 2016
- Descendant · 4 generations on · 0 of its ownK212185 Golden Isles Pedicle Screw SystemIntelivation, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K081296Preference Pedicle Screw SystemUs Spine · 2008 · cites it directly3descendants
- K081883Modification to Preference Pedicle Screw SystemUs Spine · 2008 · 2 generations on2descendants
- K162160Preference Elite Pedicle Screw SystemAmedica Corporation · 2016 · 3 generations on1descendant
- K212185Golden Isles Pedicle Screw SystemIntelivation, LLC · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041625 | LTD Polyaxial Fixation System | Us Spinal Technologies, LLC | 2004 | — |
| +1 | K081296 | Preference Pedicle Screw System | Us Spine | 2008 | — |
| +2 | K081883 | Modification to Preference Pedicle Screw System | Us Spine | 2008 | — |
| +3 | K162160 | Preference Elite Pedicle Screw System | Amedica Corporation | 2016 | — |
| +4 | K212185 | Golden Isles Pedicle Screw System | Intelivation, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 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 KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Moss Miami system Named without a submission number | |
| * | — | Xia Spine System Named without a submission number | |
| * | — | Optima Spine System Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081296 | Preference Pedicle Screw System | 2008 | 3 |
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, K081296 (Us Spine, 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of…
Read the full statement (226 words)
The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature 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.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041625: LTD Polyaxial Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041625
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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