510(k) · Cleared
ClearedFixxsure Cross Link
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineworks, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 23, 2008 as substantially equivalent to K032739 (Seaspine, 2003) and 1 other predicate after a 72-day review. Its family tree reaches back 7 generations to 1990. 91 later devices descend from it.
- Decided
- Jul 23, 2008
- Review
- 72 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K901587 (1990). 20 ancestors in all. 91 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 5 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 4 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 3 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 2 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 1 generation backK032739 Ucr Spinal SystemSeaspine · 2003
- This deviceK081331 Fixxsure Cross LinkSpineworks, LLC · 2008
- Descendant · cites it directly · 89 of its ownK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · 2 generations on · 88 of its ownK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · 3 generations on · 82 of its ownK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
- Descendant · 4 generations on · 73 of its ownK160775 Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016
- Descendant · 5 generations on · 70 of its ownK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · cites it directly89descendants
- K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 2 generations on88descendants
- K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014 · 3 generations on82descendants
- K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP · 2016 · 4 generations on73descendants
- K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018 · 5 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −6 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −5 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −4 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −2 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −1 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| 0 (this device) | K081331 | Fixxsure Cross Link | Spineworks, LLC | 2008 | — |
| +1 | K110692 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +2 | K111502 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +3 | K132049 | Thunderbolt and Lancer Pedicle Screw Systems | Choicespine | 2014 | — |
| +4 | K160775 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | 2016 | — |
| +5 | K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 8 | 0 |
| 2023 | 12 | 0 |
| 2024 | 15 | 0 |
| 2025 | 16 | 0 |
| 2026 | 15 | 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? (2)
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 |
|---|---|---|---|
| * | K032739 | Ucr Spinal SystemSummary page 1…21 CFR 888.3070 MNI/MNH 3. Predicate or legally marketed devices which are substantially equivalent: Sea Spine Crossbar (K032739) Acme/Talon Pedicle Screw system (K071824). 4. Description of the device: The SpineWorks FixxSure Cross Link al… | 2003 |
| * | K071824 | Acme Talon Pedicle ScrewSummary page 1…MNI/MNH 3. Predicate or legally marketed devices which are substantially equivalent: Sea Spine Crossbar (K032739) Acme/Talon Pedicle Screw system (K071824). 4. Description of the device: The SpineWorks FixxSure Cross Link allows spinal surgeons to convert a dual-rod constr… | 2007 |
What descends from it? (91)
See all 912 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?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K110692 (Pioneer Surgical Technology, Inc., 2011) has gone furthest, with 89 descendants of its own.
- 5 other devices also cite its predicate K032739.
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 SpineWorks FixxSure Cross Link is intended work with the Talon Pedicle Screw system 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 thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The SpineWorks FixxSure Cross Link must be used with the Talon Pedicle Screw system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081331: Fixxsure Cross Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081331
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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