510(k) · Cleared
ClearedCosmolock Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kalitec Direct, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 19, 2014 as substantially equivalent to K033090 (Alphatec Mfg., Inc., 2004) and 14 other predicates after a 93-day review. Its family tree reaches back 7 generations to 2000. 10 later devices descend from it.
- Decided
- Jun 19, 2014
- Review
- 93 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 7 generations to K000319 (2000). 84 ancestors in all, the oldest K781443 (1978). 10 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 6 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 5 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 4 generations backK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- 3 generations backK051286 Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
- 2 generations backK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
- 1 generation backK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
- This deviceK140678 Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014
- Descendant · cites it directly · 6 of its ownK163471 Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017
- Descendant · 2 generations on · 5 of its ownK180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty…Globus Medical, Inc. · 2018
- Descendant · 3 generations on · 4 of its ownK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
- Descendant · 4 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · cites it directly · 2 of its ownK172808 CosmoLock Pedicle Screw SystemKalitec Direct, LLC · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017 · cites it directly6descendants
- K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2018 · 2 generations on5descendants
- K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc. · 2018 · 3 generations on4descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 4 generations on2descendants
- K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC · 2017 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −6 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −5 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −4 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| −3 | K051286 | Zodiac Spinal Fixation System | Alphatec/Nexmed | 2005 | — |
| −2 | K093077 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2009 | — |
| −1 | K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2010 | — |
| 0 (this device) | K140678 | Cosmolock Pedicle Screw System | Kalitec Direct, LLC | 2014 | — |
| +1 | K163471 | Kalitec Direct InSePtion™ MIS Fixation System | Kalitec Direct, LLC | 2017 | — |
| +2 | K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | 2018 | — |
| +3 | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate… | Globus Medical, Inc. | 2018 | — |
| +4 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +1 | K172808 | CosmoLock Pedicle Screw System | Kalitec Direct, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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? (15)
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 |
|---|---|---|---|
| * | K033090 | Icon Polyaxial Pedicle Screw SystemSummary page 1…CFR section: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed Alphatec -ZODIACW Polyaxial Spinal Fixation System (K033090 IK042673 / K071890 Predicate Device: K093077 /K1 00685)… | 2004 |
| * | K042673 | Zodiac Polyaxial Spinal Fixation SystemSummary page 1…section: 21 CFR section 888.3070 Device panel: Orthopedic Legally Marketed Alphatec -ZODIACW Polyaxial Spinal Fixation System (K033090 IK042673 / K071890 Predicate Device: K093077 /K1 00685)… | 2004 |
| * | K071890 | Zodiac 4.0 Polyaxial Spinal Fixation SystemSummary page 1…1 CFR section 888.3070 Device panel: Orthopedic Legally Marketed Alphatec -ZODIACW Polyaxial Spinal Fixation System (K033090 IK042673 / K071890 Predicate Device: K093077 /K1 00685)… | 2007 |
| * | K093077 | Zodiac Polyaxial Spinal Fixation SystemSummary page 1…keted Alphatec -ZODIACW Polyaxial Spinal Fixation System (K033090 IK042673 / K071890 Predicate Device: K093077 /K1 00685) Stryker Spine- Xia Spinal System (K050461 / K052761 /K060361 K060748 / K071373… | 2009 |
| * | K100685 | Zodiac Polyaxial Spinal Fixation SystemSummary page 1…hatec -ZODIACW Polyaxial Spinal Fixation System (K033090 IK042673 / K071890 Predicate Device: K093077 /K1 00685) Stryker Spine- Xia Spinal System (K050461 / K052761 /K060361 K060748 / K071373… | 2010 |
| * | K050461 | Xia 4.5 Spinal SystemSummary page 1…Predicate Device: K093077 /K1 00685) Stryker Spine- Xia Spinal System (K050461 / K052761 /K060361 K060748 / K071373 K1 13666)… | 2005 |
| * | K052761 | Modification to: Xia 4.5 Spinal SystemSummary page 1…Predicate Device: K093077 /K1 00685) Stryker Spine- Xia Spinal System (K050461 / K052761 /K060361 K060748 / K071373 K1 13666)… | 2005 |
| * | K060361 | Xia Spinal System, Xia 4.5 Spinal SystemSummary page 1…cate Device: K093077 /K1 00685) Stryker Spine- Xia Spinal System (K050461 / K052761 /K060361 K060748 / K071373 K1 13666)… | 2006 |
| * | K060748 | Modification to Xia 4.5 Spinal SystemSummary page 1…ice: K093077 /K1 00685) Stryker Spine- Xia Spinal System (K050461 / K052761 /K060361 K060748 / K071373 K1 13666) Cross… | 2006 |
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 1…K093077 /K1 00685) Stryker Spine- Xia Spinal System (K050461 / K052761 /K060361 K060748 / K071373 K1 13666) Cross Medical -… | 2007 |
| * | K113666 | Xia 3 Spinal SystemSummary page 1…Stryker Spine- Xia Spinal System (K050461 / K052761 /K060361 K060748 / K071373 K1 13666) Cross Medical - Synergy VLS (K940631 / 950099) DePuy MOTEC… | 2012 |
| * | K940631 | Cross Medical - Synergy (TM) Spine SystemSummary page 1…/K060361 K060748 / K071373 K1 13666) Cross Medical - Synergy VLS (K940631 / 950099) DePuy MOTECH - Moss Miami SS (K950697) Cross Medi… | 1995 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 1…060748 / K071373 K1 13666) Cross Medical - Synergy VLS (K940631 / 950099) DePuy MOTECH - Moss Miami SS (K950697) Cross Medical - PWB… | 1997 |
| * | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle FixationSummary page 1…K1 13666) Cross Medical - Synergy VLS (K940631 / 950099) DePuy MOTECH - Moss Miami SS (K950697) Cross Medical - PWB (now Synergy) (K920116) Submitter: Kalitec Direct… | 1995 |
| * | K920116 | PWB Lumbosacral Spine SystemSummary page 1…gy VLS (K940631 / 950099) DePuy MOTECH - Moss Miami SS (K950697) Cross Medical - PWB (now Synergy) (K920116) Submitter: Kalitec Direct , LLC 618 E. South Street, Suite 500… | 1992 |
What descends from it? (10)
4 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 14 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 84 ancestors have a recall of any class.
- Of its descendants, K163471 (Kalitec Direct, LLC, 2017) has gone furthest, with 6 descendants of its own.
- 9 other devices also cite its predicate K033090.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 CosmoLock Pedicle Screw System is intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or…
Read the full statement (158 words)
The CosmoLock Pedicle Screw System is intended 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the LS-S I 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, ktyphosis, and/or lordosis), tumor pseudoarthrosis; and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140678 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140678: Cosmolock Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140678
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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