510(k) · Cleared
ClearedPicasso II Mis Spinal 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 Apr 14, 2014 as substantially equivalent to K120714 (Accel Spine, 2012) and 1 other predicate after a 75-day review. Its family tree reaches back 10 generations to 1995. 1 later device descends from it.
- Decided
- Apr 14, 2014
- Review
- 75 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K950697 (1995). 77 ancestors in all, the oldest K884263 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations between
- 3 generations backK112643 Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK120714 Picasso Mis Spinal Fixation SystemAccel Spine · 2012
- This deviceK140219 Picasso II Mis Spinal SystemAccel Spine · 2014
- Descendant · cites it directly · 0 of its ownK173185 SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation · 2018
Show all 10 generations
- Root · 10 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 9 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 8 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 6 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 5 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- 3 generations backK112643 Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK120714 Picasso Mis Spinal Fixation SystemAccel Spine · 2012
- This deviceK140219 Picasso II Mis Spinal SystemAccel Spine · 2014
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 |
|---|---|---|---|---|---|
| −10 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −9 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −8 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −6 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −5 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| −3 | K112643 | Focus Mis System | L&K BIOMED Co., Ltd. | 2012 | — |
| −2 | K120140 | Focus Spinal System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K120714 | Picasso Mis Spinal Fixation System | Accel Spine | 2012 | — |
| 0 (this device) | K140219 | Picasso II Mis Spinal System | Accel Spine | 2014 | — |
| +1 | K173185 | SEURAT™ Universal Pedicle Screw System | Ctl Medical Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K120714 | Picasso Mis Spinal Fixation SystemSummary page 1…F PREDICATE DEVICE(S) Predicate devices include the following systems: - Accel Spine: Picasso MIS Spinal System (K120714) - Accel Spine: Raphael System (K132365)… | 2012 |
| * | K132365 | Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationSummary page 1…following systems: - Accel Spine: Picasso MIS Spinal System (K120714) - Accel Spine: Raphael System (K132365) K140219 - Page 2 of 2 DEVICE… | 2013 |
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 19 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 8 of the 77 ancestors have a recall of any class.
- Of its descendants, K173185 (Ctl Medical Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120714.
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 Picasso 11 MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Picasso 11 MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso 11 MIS Spinal System is intended for noncervical…
Read the full statement (195 words)
The Picasso 11 MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. And the Picasso 11 MIS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The Picasso 11 MIS Spinal System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e.. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis. and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the Picasso 11MIS Spinal System is intended for noncervical pedlicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis. and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140219 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140219: Picasso II Mis Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140219
Report an extraction error
Are you the manufacturer?
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