510(k) · Cleared
ClearedDali Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accel Spine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 21, 2012 as substantially equivalent to K120270 (L&K BIOMED Co., Ltd., 2012) and 11 other predicates after a 115-day review. Its family tree reaches back 11 generations to 1999. 1 later device descends from it.
- Decided
- Sep 21, 2012
- Review
- 115 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 11 generations to K990745 (1999). 114 ancestors in all, the oldest K944736 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 1 generation backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- This deviceK121568 Dali Spinal Fixation SystemAccel Spine · 2012
- Descendant · cites it directly · 0 of its ownK173185 SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation · 2018
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 5 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 4 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 1 generation backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- This deviceK121568 Dali Spinal Fixation SystemAccel Spine · 2012
Most influential descendants
Showing 1 of 1 · See all- K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −5 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −4 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −3 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −2 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −1 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| 0 (this device) | K121568 | Dali Spinal Fixation System | Accel Spine | 2012 | — |
| +1 | K173185 | SEURAT™ Universal Pedicle Screw System | Ctl Medical Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 13 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 10 | 0 |
| 2004 | 7 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (12)
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 |
|---|---|---|---|
| * | K120270 | Venus Spinal Fixation SystemSummary page 1…3) Pedicle Screw Spinal System, 21 CFR §888.3070 3. Identification of Legally Marketed Devices L&K BIOMED: Venus Spinal Fixation System (K120270) L&K RIOMED: Venus Basic Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System… | 2012 |
| * | K100706 | Venus Basic Spinal Fixation SystemSummary page 1…3. Identification of Legally Marketed Devices L&K BIOMED: Venus Spinal Fixation System (K120270) L&K RIOMED: Venus Basic Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825… | 2010 |
| * | K103085 | Venus Basic Spinal Fixation SystemSummary page 1…Identification of Legally Marketed Devices L&K BIOMED: Venus Spinal Fixation System (K120270) L&K RIOMED: Venus Basic Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825, K10248… | 2011 |
| * | K091717 | Any Plus Spinal Fixation SystemSummary page 1…: Venus Spinal Fixation System (K120270) L&K RIOMED: Venus Basic Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: XiaRlll Spinal System (K071373,K083… | 2010 |
| * | K062513 | Apex Spine SystemSummary page 1…L&K RIOMED: Venus Basic Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: XiaRlll Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal… | 2006 |
| * | K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSummary page 1…ED: Venus Basic Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: XiaRlll Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal and Syn… | 2010 |
| * | K102488 | Apex Spine System W/ Cocr RodsSummary page 1…Basic Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: XiaRlll Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal and Synthes 1155… | 2010 |
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 1…GS Medical: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: XiaRlll Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal and Synthes 1155 Iliosacral System (K022949,K082572) 4. Device Descri… | 2007 |
| * | K083393 | Xia 3 Spinal SystemSummary page 1…cal: Anyplus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: XiaRlll Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal and Synthes 1155 Iliosacral System (K022949,K082572) 4. Device Description… | 2009 |
| * | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodSummary page 1…plus Spinal Fixation System (K091717) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: XiaRlll Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal and Synthes 1155 Iliosacral System (K022949,K082572) 4. Device Description This… | 2009 |
| * | K022949 | Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature UssSummary page 1…513,K092825, K102488) Stryker Spine: XiaRlll Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal and Synthes 1155 Iliosacral System (K022949,K082572) 4. Device Description This system is comprised of screws, set screws, rods, crosslink and connectors. The… | 2003 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 1…825, K102488) Stryker Spine: XiaRlll Spinal System (K071373,K083393,K091291) Synthes Spine: USS Polyaixal and Synthes 1155 Iliosacral System (K022949,K082572) 4. Device Description This system is comprised of screws, set screws, rods, crosslink and connectors. The compon… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173185 | SEURAT™ Universal Pedicle Screw System | 2018 | 0 |
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 13 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 12 of the 114 ancestors have a recall of any class.
- Of its descendants, K173185 (Ctl Medical Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K120270.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the…
Read the full statement (110 words)
The Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use:
degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies);
spondylolisthesis;
trauma (i.e. fracture or dislocation);
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
tumor;
stenosis, and;
failed previous fusion (pseudoarthrosis)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121568: Dali Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121568
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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