510(k) · Cleared
Recalled · Class II · 2015Excella Iii-D Spinal Deformity System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 7, 2014 as substantially equivalent to K102248 (Innovasis, Inc., 2010) and 3 other predicates after a 97-day review. Its family tree reaches back 9 generations to 1999. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- May 7, 2014
- Review
- 97 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 9 generations to K990745 (1999). 68 ancestors in all, the oldest K901587 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations between
- 3 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 2 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 1 generation backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- This deviceK140238 Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK241276 Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK251073 Innovasis Navigation Instruments (Vector G-E Navigation Instruments…Innovasis, Inc. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK162143 FixxSure® X-LinkInnovasis, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 7 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 6 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 5 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 4 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 3 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 2 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 1 generation backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- This deviceK140238 Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K241276Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024 · cites it directly1descendant
- K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc. · 2025 · 2 generations on0descendants
- K162143FixxSure® X-LinkInnovasis, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −8 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −7 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −6 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −5 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −4 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −3 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −2 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −1 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| 0 (this device) | K140238 | Excella Iii-D Spinal Deformity System | Innovasis, Inc. | 2014 | — |
| +1 | K241276 | Vector™ Pedicle Screw System | Innovasis, Inc. | 2024 | 1 |
| +2 | K251073 | Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the… | Innovasis, Inc. | 2025 | 1 |
| +1 | 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 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 5 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102248 | Excella II Spinal System Model EC2-00Summary page 2…Development, Validation and Routine Control of a Sterilization Process for Medical Devices Substantially Equivalent Device: K102248 Excella 110 Spinal System K071 921 Excellao Spinal System K042143 Excellao… | 2010 |
| * | K071921 | Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Summary page 2…a Sterilization Process for Medical Devices Substantially Equivalent Device: K102248 Excella 110 Spinal System K071 921 Excellao Spinal System K042143 Excellao-M Spinal System K100788 Globus Rev… | 2007 |
| * | K042143 | Excella-M Spinal SystemSummary page 2…for Medical Devices Substantially Equivalent Device: K102248 Excella 110 Spinal System K071 921 Excellao Spinal System K042143 Excellao-M Spinal System K100788 Globus Revere® Stabilization System Device Description: The Excel… | 2004 |
| * | K100788 | Cocr RodsSummary page 2…2248 Excella 110 Spinal System K071 921 Excellao Spinal System K042143 Excellao-M Spinal System K100788 Globus Revere® Stabilization System Device Description: The Excel/a 111-D9 pedicle screws, hooks and connectors are an… | 2010 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2015 | Class II | Z-0662-2016 | Labeling mix-ups | Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels. |
| Jul 7, 2014 | Class II | Z-2067-2014 | Process control | Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 68 ancestors have a recall of any class.
- Of its descendants, K241276 (Innovasis, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K102248.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Innovasis Excella Il-D Spinal Deformity System, when used as a posterior 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 the thoracic, lumbar and sacral spine: Degenerative disc disease (DOD-defined as discogenic back pain with degeneration of the disc confirmed by…
Read the full statement (294 words)
The Innovasis Excella Il-D Spinal Deformity System, when used as a posterior 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 the thoracic, lumbar and sacral spine: Degenerative disc disease (DOD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenemative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis. kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
The Innovasis Excella llI-D Spinal Deformity System, is also indicated for treatment of severe spondylolisthesis (Grades 3 & 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bonc graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L-3-sacrum/ilium.
When used as Aposterior non-pedicle screw fixation system, the Innovasis Excella 1l-D3 Spinal Deformity System is intended for the treatment of degenerative disc disease (DDD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e.. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture. pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are TI-sacrum/ilium.
When used as an anterolateral thoracolumbar system, the Innovasis Excella lll-D Spinal Deformity System is intended for anterolateral screw fixation for the following indications: Degenerative disc disease (ODD-defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis. tumor resection, and/or failed previous fusion. Levels of screw fixation are TS-L5.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140238: Excella Iii-D Spinal Deformity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140238
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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