510(k) · Cleared
ClearedFixxSure® X-Link
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 23, 2016 as substantially equivalent to K081331 (Spineworks, LLC, 2008) and 2 other predicates after a 53-day review. Its family tree reaches back 10 generations to 1999.
- Decided
- Sep 23, 2016
- Review
- 53 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K990745 (1999). 75 ancestors in all, the oldest K901587 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK140238 Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014 · Recalled
- This deviceK162143 FixxSure® X-LinkInnovasis, Inc. · 2016
Show all 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 4 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK140238 Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014 · Recalled
- This deviceK162143 FixxSure® X-LinkInnovasis, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −4 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −3 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −2 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −1 | K140238 | Excella Iii-D Spinal Deformity System | Innovasis, Inc. | 2014 | 2 |
| 0 (this device) | K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K081331 | Fixxsure Cross LinkSummary page 6…3 Page 3 of 4 FixxSure® X-Link Primary Predicate: K081331 SpineWorks FixxSure® X-Link This predicate has not been subject to a design-related recall. Additional… | 2008 |
| * | K140238 | Excella Iii-D Spinal Deformity SystemSummary page 6…ary Predicate: K081331 SpineWorks FixxSure® X-Link This predicate has not been subject to a design-related recall. Additional Predicates: K140238 Innovasis Excella III-D® Spinal System K032739 SeaSpine Crossbar Device Description: The SpineWorks FixxS… | 2014 |
| * | K032739 | Ucr Spinal SystemSummary page 6…This predicate has not been subject to a design-related recall. Additional Predicates: K140238 Innovasis Excella III-D® Spinal System K032739 SeaSpine Crossbar Device Description: The SpineWorks FixxSure X-Link is a transverse stabilizing device util… | 2003 |
| † | K102248 | Excella II Spinal System Model EC2-00 | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 75 ancestors have a recall of any class.
- 1 other device also cites its predicate K081331.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 SpineWorks™ FixxSure® X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: i) Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; ii) Degenerative spondylolisthesis with objective evidence of…
Read the full statement (99 words)
The SpineWorks™ FixxSure® X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:
i) Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra;
ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
iii) Fracture;
iv) Dislocation;
v) Scoliosis;
vi) Kyphosis;
vii) Spinal tumor; and
viii) Previous failed fusion (pseudarthrosis).
The SpineWorks™ FixxSure® X-Link can also be used with the Talon® Pedicle Screw System.*
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162143: FixxSure® X-Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162143
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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