510(k) · Cleared
ClearedPreference Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Spine · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 6, 2008 as substantially equivalent to K041625 (Us Spinal Technologies, LLC, 2004) and 2 other predicates after a 30-day review. Its family tree reaches back 6 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 6, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K992147 (2000). 22 ancestors in all, the oldest K980447 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK992147 Triple-Fix Spinal Fixation SystemAdvanced Spine Technology, Inc. · 2000
- 5 generations backK001668 Global Spinal Fixation SystemD.K.M. Co., Ltd. · 2000
- 4 generations backK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- 3 generations backK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- 2 generations backK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- 1 generation backK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- This deviceK081296 Preference Pedicle Screw SystemUs Spine · 2008
- Descendant · cites it directly · 2 of its ownK081883 Modification to Preference Pedicle Screw SystemUs Spine · 2008
- Descendant · 2 generations on · 1 of its ownK162160 Preference Elite Pedicle Screw SystemAmedica Corporation · 2016
- Descendant · 3 generations on · 0 of its ownK212185 Golden Isles Pedicle Screw SystemIntelivation, LLC · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K992147 | Triple-Fix Spinal Fixation System | Advanced Spine Technology, Inc. | 2000 | — |
| −5 | K001668 | Global Spinal Fixation System | D.K.M. Co., Ltd. | 2000 | — |
| −4 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| −3 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| −2 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| −1 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| 0 (this device) | K081296 | Preference Pedicle Screw System | Us Spine | 2008 | — |
| +1 | K081883 | Modification to Preference Pedicle Screw System | Us Spine | 2008 | — |
| +2 | K162160 | Preference Elite Pedicle Screw System | Amedica Corporation | 2016 | — |
| +3 | K212185 | Golden Isles Pedicle Screw System | Intelivation, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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 MNH? 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? (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 |
|---|---|---|---|
| * | K041625 | LTD Polyaxial Fixation SystemSummary page 2…nt to previously cleared devices and has the same indications for use, design, function, and materials used. These devices include the LTD Fixation System from US Spine (K041625 and K062785) and the Quantum Spinal System from Pioneer Surgical (K080518). Performance Testing: The pre-clinical testing perfor… | 2004 |
| * | K062785 | LTD Polyaxial Fixation SystemSummary page 2…usly cleared devices and has the same indications for use, design, function, and materials used. These devices include the LTD Fixation System from US Spine (K041625 and K062785) and the Quantum Spinal System from Pioneer Surgical (K080518). Performance Testing: The pre-clinical testing performed indicate… | 2006 |
| * | K080518 | Pioneer Surgical Technology Quantum Spinal SystemSummary page 2…ign, function, and materials used. These devices include the LTD Fixation System from US Spine (K041625 and K062785) and the Quantum Spinal System from Pioneer Surgical (K080518). Performance Testing: The pre-clinical testing performed indicated that the Preference Pedicle Screw System is substantially eq… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081883 | Modification to Preference Pedicle Screw System | 2008 | 2 |
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?
- The line of descent spans 8 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K081883 (Us Spine, 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Preference Pedicle 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 Preference Pedicle Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective…
Read the full statement (227 words)
The Preference Pedicle 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 Preference Pedicle 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 Preference Pedicle Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) 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 Preference Pedicle 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/K081296 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081296: Preference Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081296
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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