510(k) · Cleared
Recalled · Class II · 2013Illico Mis Posterior Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 14, 2013 as substantially equivalent to K033090 (Alphatec Mfg., Inc., 2004) and 4 other predicates after an 83-day review. Its family tree reaches back 8 generations to 2004. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 14, 2013
- Review
- 83 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 8 generations to K040583 (2004). 70 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 5 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 4 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 3 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 2 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 1 generation backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- This deviceK123623 Illico Mis Posterior Fixation SystemAlphatec Spine, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK181980 OsseoScrew SystemAlphatec Spine, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK202327 Invictus™ OsseoScrew® SystemAlphatec Spine, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −5 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −3 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −1 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K123623 | Illico Mis Posterior Fixation System | Alphatec Spine, Inc. | 2013 | — |
| +1 | K181980 | OsseoScrew System | Alphatec Spine, Inc. | 2018 | — |
| +2 | K202327 | Invictus™ OsseoScrew® System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 8 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 11 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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? (5)
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 2…ivalence Claimed: The lilico MIS Posterior Fixation System is substantially equivalent to Alphatec Spine's previously cleared Icon/Zodiac Polyaxial Pedicle Screw System (K033090) and Zodiac Cannulated Polyaxial Spinal Fixation System (K042673, K071890, and K091 189). The Illico MIS Posterior Fixation Syste… | 2004 |
| * | K042673 | Zodiac Polyaxial Spinal Fixation SystemSummary page 2…stantially equivalent to Alphatec Spine's previously cleared Icon/Zodiac Polyaxial Pedicle Screw System (K033090) and Zodiac Cannulated Polyaxial Spinal Fixation System (K042673, K071890, and K091 189). The Illico MIS Posterior Fixation System instruments are Substantially equivalent to instrumentation in… | 2004 |
| * | K071890 | Zodiac 4.0 Polyaxial Spinal Fixation SystemSummary page 2…y equivalent to Alphatec Spine's previously cleared Icon/Zodiac Polyaxial Pedicle Screw System (K033090) and Zodiac Cannulated Polyaxial Spinal Fixation System (K042673, K071890, and K091 189). The Illico MIS Posterior Fixation System instruments are Substantially equivalent to instrumentation in Medtronic… | 2007 |
| * | K091189 | Zodiac Polyaxial Spinal Fixation SystemSummary page 2…to Alphatec Spine's previously cleared Icon/Zodiac Polyaxial Pedicle Screw System (K033090) and Zodiac Cannulated Polyaxial Spinal Fixation System (K042673, K071890, and K091 189). The Illico MIS Posterior Fixation System instruments are Substantially equivalent to instrumentation in Medtronic's CID Horizon… | 2009 |
| * | K091442 | CD Horizon Spinal SystemSummary page 2…(K042673, K071890, and K091 189). The Illico MIS Posterior Fixation System instruments are Substantially equivalent to instrumentation in Medtronic's CID Horizon System (K09 1442). Technical Characteristics Tile intended use and technological features of the Illico MIS Posterior Fixation System Implants do… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181980 | OsseoScrew System | 2018 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2013 | Class II | Z-2086-2013 | Equipment maintenance | The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 10 of the 70 ancestors have a recall of any class.
- Of its descendants, K181980 (Alphatec Spine, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K033090.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Illico MIS Posterior Fixation System is intended for posterior, non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin wit 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/or…
Read the full statement (102 words)
The Illico MIS Posterior Fixation System is intended for posterior, non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin wit 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/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft. It is intended that this device, in any system configuration, be removed after development of solid fusion mass.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123623: Illico Mis Posterior 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/K123623
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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