510(k) · Cleared
ClearedModification to: Expedium Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 25, 2009 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) and 6 other predicates after a 29-day review. Its family tree reaches back 9 generations to 1985.
- Decided
- Sep 25, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 9 generations to K853033 (1985). 35 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 5 generations between
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- This deviceK092626 Modification to: Expedium Spine SystemDepuy Spine, Inc. · 2009
Show all 9 generations
- Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- This deviceK092626 Modification to: Expedium Spine SystemDepuy Spine, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −8 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −7 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −6 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −5 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −4 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −3 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| 0 (this device) | K092626 | Modification to: Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 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? (7)
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 1…mber: 87 Product Code(s): NKB, KWQ, KWYP, MNIH, MNI Proprietary Name: EXPEDTLJM Spine System Predicate Devices: EXPEDIUM Spine System (K033901, K041 119, KO051024, K062174) MOSS MIAMI Spine System (K983583)… | 2004 |
| * | K041119 | Expedium Spine SystemSummary page 1…Product Code(s): NKB, KWQ, KWYP, MNIH, MNI Proprietary Name: EXPEDTLJM Spine System Predicate Devices: EXPEDIUM Spine System (K033901, K041 119, KO051024, K062174) MOSS MIAMI Spine System (K983583)… | 2004 |
| * | K051024 | Expedium Spine SystemSummary page 1…uct Code(s): NKB, KWQ, KWYP, MNIH, MNI Proprietary Name: EXPEDTLJM Spine System Predicate Devices: EXPEDIUM Spine System (K033901, K041 119, KO051024, K062174) MOSS MIAMI Spine System (K983583) C… | 2005 |
| * | K062174 | Modification to Expedium Spine SystemSummary page 1…IH, MNI Proprietary Name: EXPEDTLJM Spine System Predicate Devices: EXPEDIUM Spine System (K033901, K041 119, KO051024, K062174) MOSS MIAMI Spine System (K983583) CD HORIZON (Addition of BioDur 108 Scr… | 2006 |
| * | K983583 | Depuy Acromed Moss and Moss Miami Spinal SystemsSummary page 1…Predicate Devices: EXPEDIUM Spine System (K033901, K041 119, KO051024, K062174) MOSS MIAMI Spine System (K983583) CD HORIZON (Addition of BioDur 108 Screws) (K034056)… | 1998 |
| * | K034056 | Modification to CD Horizon Spinal SystemSummary page 1…062174) MOSS MIAMI Spine System (K983583) CD HORIZON (Addition of BioDur 108 Screws) (K034056) MONARCH Spine System (K023438) Device Description: The subject EXPEDTUM Spine System componen… | 2004 |
| * | K023438 | Modification to Monarch Spine SystemSummary page 1…(K983583) CD HORIZON (Addition of BioDur 108 Screws) (K034056) MONARCH Spine System (K023438) Device Description: The subject EXPEDTUM Spine System components consist of implants that are a… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 35 ancestors has a recall.
- 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. 2009, 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 EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic…
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 EXPEDIUM 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/K092626 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092626: Modification to: Expedium Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092626
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