510(k) · Cleared
ClearedExpedium Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, A Johnson & Johnson Company · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 16, 2010 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) and 4 other predicates after a 129-day review. Its family tree reaches back 10 generations to 1985. 218 later devices descend from it.
- Decided
- Dec 16, 2010
- Review
- 129 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K853033 (1985). 48 ancestors in all. 218 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- This deviceK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
- Descendant · cites it directly · 203 of its ownK111571 Viper SystemsJohnson & Johnson · 2011
- Descendant · 2 generations on · 94 of its ownK121020 Viper SystemDepuy Spine, Inc. · 2012
- Descendant · 3 generations on · 84 of its ownK153442 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable…Medtronic Sofamor Danek USA, Inc. · 2016
- Descendant · 2 generations on · 50 of its ownK121728 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · 4 generations on · 48 of its ownK161014 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 1 generation backK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- This deviceK102249 Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company · 2010
Showing 5 of 218 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 218 · See all- K111571Viper SystemsJohnson & Johnson · 2011 · cites it directly203descendants
- K121020Viper SystemDepuy Spine, Inc. · 2012 · 2 generations on94descendants
- K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc. · 2016 · 3 generations on84descendants
- K121728Tiger Spine SystemCorelink, LLC · 2012 · 2 generations on50descendants
- K161014NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · 4 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −1 | K070387 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| 0 (this device) | K102249 | Expedium Spine System | Depuy Spine, A Johnson & Johnson Company | 2010 | — |
| +1 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| +2 | K121020 | Viper System | Depuy Spine, Inc. | 2012 | — |
| +3 | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for… | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +2 | K121728 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +4 | K161014 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 10 | 0 |
| 2014 | 8 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 8 | 0 |
| 2018 | 17 | 0 |
| 2019 | 12 | 0 |
| 2020 | 14 | 0 |
| 2021 | 9 | 0 |
| 2022 | 17 | 0 |
| 2023 | 27 | 0 |
| 2024 | 26 | 0 |
| 2025 | 25 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K033901 | Merlin Spine SystemSummary page 2…in skeletally mature patients. Materials: Manufactured from ASTM F 136 implant grade titanium alloy. Predicate Devices: EXPEDIUM Spine System (K(033901, K(05 1024, K062174, K(070387) ISOLA Spine System (K(980485) Summary of Technological… | 2004 |
| * | K051024 | Expedium Spine System | 2005 |
| * | K062174 | Modification to Expedium Spine SystemSummary page 2…lly mature patients. Materials: Manufactured from ASTM F 136 implant grade titanium alloy. Predicate Devices: EXPEDIUM Spine System (K(033901, K(05 1024, K062174, K(070387) ISOLA Spine System (K(980485) Summary of Technological Differences:… | 2006 |
| * | K070387 | Expedium Spine SystemSummary page 2…Manufactured from ASTM F 136 implant grade titanium alloy. Predicate Devices: EXPEDIUM Spine System (K(033901, K(05 1024, K062174, K(070387) ISOLA Spine System (K(980485) Summary of Technological Differences: The purpose of this submissio… | 2007 |
| * | K980485 | Isola Spinal SystemSummary page 2…e titanium alloy. Predicate Devices: EXPEDIUM Spine System (K(033901, K(05 1024, K062174, K(070387) ISOLA Spine System (K(980485) Summary of Technological Differences: The purpose of this submission is to obtain market clearance for… | 1998 |
What descends from it? (218)
See all 2185 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)
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 25 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 48 ancestors has a recall.
- Of its descendants, K111571 (Johnson & Johnson, 2011) has gone furthest, with 203 descendants of its own.
- 34 other devices also cite its predicate K033901.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 EXPEDIUM Spine 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. The EXPEDJUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin…
Read the full statement (102 words)
The EXPEDIUM Spine 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.
The EXPEDJUM Spine System is intended for noncervical pedicle fixation and nonpedicle 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/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102249: Expedium Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102249
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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