510(k) Report

510(k) · Cleared

Cleared

Solstice Cross Connector

K120998510(k) SpecialCleared Oct 1, 2012182-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Life Spine · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Oct 1, 2012 as substantially equivalent to K090343 (Life Spine, 2009) and 3 other predicates after a 182-day review. Its family tree reaches back 14 generations to 2001. 1 later device descends from it.

Decided
Oct 1, 2012
Review
182 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
4

Its longest line of descent runs back 14 generations to K003155 (2001). 109 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 5 other ancestors2008: 6 other ancestors2011: 1 other ancestor2010: 1 other ancestor2007: 4 other ancestors2004: 24 other ancestors2003: 8 other ancestors2002: 8 other ancestors2001: 7 other ancestors2006: 4 other ancestors2005: 10 other ancestors2000: 7 other ancestors1999: 5 other ancestors1998: 2 other ancestors1997: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestor2015: 1 descendant clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004×3: 3 generations cleared close together, K060719 (2006), K061938 (2006), K062427 (2006) K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 19 other ancestors3 generations back: 19 other ancestors4 generations back: 16 other ancestors5 generations back: 3 other ancestors6 generations back: 5 other ancestors7 generations back: 11 other ancestors8 generations back: 18 other ancestors9 generations back: 1 other ancestor 1 generation forward: 1 descendant K113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K062427 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K061938 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−10−50
  1. Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 10 generations between
  3. 3 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  4. 2 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  5. 1 generation backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  6. This deviceK120998 Solstice Cross ConnectorLife Spine · 2012
  7. Descendant · cites it directly · 0 of its ownK150229 SOLSTICE OCT SystemLife Spine, Inc. · 2015
Show all 14 generations
  1. Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 13 generations backK012254 VBROsteotech, Inc. · 2001
  3. 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 5 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 4 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 3 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 2 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 1 generation backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. This deviceK120998 Solstice Cross ConnectorLife Spine · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K150229SOLSTICE OCT SystemLife Spine, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−13K012254VBROsteotech, Inc.2001—
−12K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−11K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−10K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−9K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−8K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−6K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−5K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−4K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−3K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−2K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
0 (this device)K120998Solstice Cross ConnectorLife Spine2012—
+1K150229SOLSTICE OCT SystemLife Spine, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199710
199820
199950
200070
200170
200280
200380
2004240
2005100
200640
200740
200860
200950
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K120998, 2001–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KWP? 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
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K090343Sentinel Spinal System
Our reading of the summary gave K093043, FDA’s number for Zirconia Syringe Needle (Kuo Tai Hospital Managements & Consultant Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “The Sentinel Spinal System”.
Life Spine2009—
*K083073Theken Atoll Cervico-Thoracic System
Summary page 1
…Fixation Orthosis. Predicate Devices: The Sentinel Spinal System (K093043), Theken Atoll System (K083073), Biomet Altius System (KI 13593), Blackstone Ascent System (K073654) Device Description: T…
Theken Spine, LLC2009—
*K113593Nextgen Altius Oct System
Cleared while this submission was under review
Biomet Spine (Aka Ebi, LLC)2012—
*K073654Blackstone Ascent Poct System Parallel Rod Connector
Summary page 1
…043), Theken Atoll System (K083073), Biomet Altius System (KI 13593), Blackstone Ascent System (K073654) Device Description: The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple compone nt sys…
Blackstone Medical, Inc.2008—

Also cleared against K090343: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150229SOLSTICE OCT SystemLife Spine, Inc.20150

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 11 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 7 of the 109 ancestors have a recall of any class.
  • Of its descendants, K150229 (Life Spine, Inc., 2015) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K090343.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision…

Read the full statement (145 words)

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput -T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks, rods, and cross connectors are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Indications for use as stated in the FDA summary.

Also cleared against K090343

4 other devices cite the same predicate.

  • K162266The Cranial Fusion SystemLife Spine, Inc. · 2017
  • K142253SOLSTICE OCT SystemLife Spine, Inc. · 2015
  • K143249SOLSTICE OCT SystemLife Spine, Inc. · 2015
  • K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015

More from Life Spine

36 FDA decisions under this applicant name. See the company

  • K182470Plateau Spacer SystemLife Spine · 2018
  • K160169The Life Spine Subtalar Implant SystemLife Spine · 2016
  • K150368Tarsa-Link Wedge Fixation SystemLife Spine · 2015
  • K141905Pro-Link Wedge SystemLife Spine · 2014
  • K133717Longbow Spacer SystemLife Spine · 2014

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K120998 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120998: Solstice Cross Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120998

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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