510(k) · Cleared
Recalled · Class II · 2026X-spine Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Sep 25, 2015 as substantially equivalent to K122145 (Lanx, Inc., 2012) and 2 other predicates after a 56-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 25, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K950697 (1995). 75 ancestors in all, the oldest K933881 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 5 generations between
- 3 generations backK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- 2 generations backK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 1 generation backK122145 Lanx Spinal Fixation SystemLanx, Inc. · 2012 · Recalled
- This deviceK152132 X-spine Pedicle Screw SystemX-Spine Systems, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK180153 X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
Show all 9 generations
- Root · 9 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 8 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 5 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 4 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- 2 generations backK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 1 generation backK122145 Lanx Spinal Fixation SystemLanx, Inc. · 2012 · Recalled
- This deviceK152132 X-spine Pedicle Screw SystemX-Spine Systems, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −8 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −5 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −4 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| −2 | K120099 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −1 | K122145 | Lanx Spinal Fixation System | Lanx, Inc. | 2012 | 1 |
| 0 (this device) | K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015 | — |
| +1 | K180153 | X-spine Cortical Bone Screw System | X-Spine Systems, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 9 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 MNI? 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 |
|---|---|---|---|
| * | K122145 | Lanx Spinal Fixation SystemSummary page 4… Xpress™ Minimally Invasive Pedicle Screw System III. PREDICATE DEVICES Primary Predicate: Lanx Spinal Fixation System [Silverton; Silverton‐D] (K122145) o This predicate has not been subject to a design related recall. Additional Predicate: Fortex Pedicle S… | 2012 |
| * | K090224 | Fortex Pedicle Screw SystemSummary page 4…rton; Silverton‐D] (K122145) o This predicate has not been subject to a design related recall. Additional Predicate: Fortex Pedicle Screw System (K090224, K120832) [X‐spine, Inc.] o This predicate has not been subject to a design related recall.… | 2009 |
| * | K120832 | Fortex Pedicle Screw SystemSummary page 4…verton‐D] (K122145) o This predicate has not been subject to a design related recall. Additional Predicate: Fortex Pedicle Screw System (K090224, K120832) [X‐spine, Inc.] o This predicate has not been subject to a design related recall.… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180153 | X-spine Cortical Bone Screw System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2026 | Class II | Z-1773-2026 | Under Investigation by firm | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 10 of the 75 ancestors have a recall of any class.
- Of its descendants, K180153 (X-Spine Systems, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122145.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The X-spine℠ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the X-spine℠ Pedicle Screw System is intended for posterior, non-cervical (T1-S2/ilium) pedicle spinal…
Read the full statement (126 words)
The X-spine℠ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the X-spine℠ Pedicle Screw System is intended for posterior, non-cervical (T1-S2/ilium) pedicle spinal fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152132: X-spine Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152132
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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