510(k) · Cleared
ClearedOsseoScrew 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 Sep 25, 2018 as substantially equivalent to K123623 (Alphatec Spine, Inc., 2013) and 1 other predicate after a 62-day review. Its family tree reaches back 14 generations to 2004. 1 later device descends from it.
- Decided
- Sep 25, 2018
- Review
- 62 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K040583 (2004). 114 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations between
- 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 2 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 1 generation backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- This deviceK181980 OsseoScrew SystemAlphatec Spine, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK202327 Invictus™ OsseoScrew® SystemAlphatec Spine, Inc. · 2020
Show all 14 generations
- Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 11 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 9 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 8 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 6 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 5 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 4 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 2 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 1 generation backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- This deviceK181980 OsseoScrew SystemAlphatec Spine, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −11 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −9 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −8 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −6 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −5 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −4 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −3 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −2 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| −1 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| 0 (this device) | K181980 | OsseoScrew System | Alphatec Spine, Inc. | 2018 | — |
| +1 | 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 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 20 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K123623 | Illico Mis Posterior Fixation SystemSummary page 4…lation Number: 21 CFR 888.3070 Regulatory Class: Class II Product Code: NKB LEGALLY MARKETED PREDICATE DEVICES Primary Predicate: 510(k) Product Name Clearance Date K123623 Illico™ MIS Posterior Fixation System February 14, 2013 Additional Predicates: 510(k) Product Name Clearance Date CONFIDENCE™ Hig… | 2013 |
| * | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsSummary page 4…Date K123623 Illico™ MIS Posterior Fixation System February 14, 2013 Additional Predicates: 510(k) Product Name Clearance Date CONFIDENCE™ High Viscosity Spinal Cement, K160879 | 1pER® And EXPEDIUM® Fenestrated Screw Systems | ecember 20,2016 DEVICE DESCRIPTION The OsseoScrew is a pedicle screw system t… | 2016 |
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 |
|---|---|---|---|
| K202327 | Invictus™ OsseoScrew® System | 2020 | 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 14 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 22 of the 114 ancestors have a recall of any class.
- Of its descendants, K202327 (Alphatec Spine, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 OsseoScrew™ System (for use with the Zodiac™ Spinal Fixation System and Illico™ MIS Posterior Fixation System) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181980: OsseoScrew System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181980
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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