510(k) · Cleared
Recalled · Class II · 2015Expedium Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 31, 2010 as substantially equivalent to K092473 (Depuy Spine, Inc., 2009) and 11 other predicates after a 137-day review. Its family tree reaches back 12 generations to 1985. 1 of the 338 devices in its family, counting itself, has a Class I recall. 260 later devices descend from it. It has been recalled once.
- Decided
- Aug 31, 2010
- Review
- 137 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 12
Its longest line of descent runs back 12 generations to K853033 (1985). 77 ancestors in all. 260 later devices descend from it, 5 citing it directly. 1 of the 338 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK101070 Expedium Spine SystemMedos International SARL · 2010
- Descendant · cites it directly · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · 2 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 3 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- Descendant · 2 generations on · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
- Descendant · 3 generations on · 96 of its ownK150552 ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · Recalled
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK101070 Expedium Spine SystemMedos International SARL · 2010
Showing 5 of 260 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 260 · See all- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · cites it directly225descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 2 generations on172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 3 generations on158descendants
- K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · 2 generations on97descendants
- K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc. · 2015 · 3 generations on96descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −1 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K101070 | Expedium Spine System | Medos International SARL | 2010 | — |
| +1 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| +2 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +3 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| +2 | K123783 | Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants | Globus Medical, Inc. | 2013 | — |
| +3 | K150552 | ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS | Globus Medical, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 9 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 14 | 0 |
| 2019 | 14 | 0 |
| 2020 | 19 | 0 |
| 2021 | 15 | 1 |
| 2022 | 24 | 0 |
| 2023 | 35 | 0 |
| 2024 | 41 | 0 |
| 2025 | 36 | 0 |
| 2026 | 31 | 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.
1 device in this family has a Class I recall. 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? (12)
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 |
|---|---|---|---|
| * | K092473 | Expedium Spine SystemSummary page 3…rade titanium alloy, and ASTM F 562 implant grade cobalt-nickel-Chro01miumii-moiybdenumi alloy. Predicate Devices: EXPEDIUM Spine System - K092473. K,109023)0. K080313I' K062l74, and K071495 ISOLA System - K013)44 1, K0 10972. a… | 2009 |
| * | K090230 | Expedium Spine System | 2009 |
| * | K080313 | Modification to Expedium Spine SystemSummary page 3…and ASTM F 562 implant grade cobalt-nickel-Chro01miumii-moiybdenumi alloy. Predicate Devices: EXPEDIUM Spine System - K092473. K,109023)0. K080313I' K062l74, and K071495 ISOLA System - K013)44 1, K0 10972. and K980485… | 2008 |
| * | K062174 | Modification to Expedium Spine System | 2006 |
| * | K071495 | Expedium 4.5MM Spine SystemSummary page 3…grade cobalt-nickel-Chro01miumii-moiybdenumi alloy. Predicate Devices: EXPEDIUM Spine System - K092473. K,109023)0. K080313I' K062l74, and K071495 ISOLA System - K013)44 1, K0 10972. and K980485 MONARCH Spine System - K024348 an… | 2007 |
| * | K013441 | Isola Polyaxial Washer | 2001 |
| * | K010972 | Isola Band ClampSummary page 3…icate Devices: EXPEDIUM Spine System - K092473. K,109023)0. K080313I' K062l74, and K071495 ISOLA System - K013)44 1, K0 10972. and K980485 MONARCH Spine System - K024348 and K0 10576 VSP System - K9843 50… | 2001 |
| * | K980485 | Isola Spinal SystemSummary page 3…EXPEDIUM Spine System - K092473. K,109023)0. K080313I' K062l74, and K071495 ISOLA System - K013)44 1, K0 10972. and K980485 MONARCH Spine System - K024348 and K0 10576 VSP System - K9843 50… | 1998 |
| * | K024348 | Monarch Spine SystemSummary page 3…313I' K062l74, and K071495 ISOLA System - K013)44 1, K0 10972. and K980485 MONARCH Spine System - K024348 and K0 10576 VSP System - K9843 50 TJMX System - K98 1274 Summary of Technologica… | 2003 |
| * | K010576 | Monarch Spine SystemSummary page 3…K062l74, and K071495 ISOLA System - K013)44 1, K0 10972. and K980485 MONARCH Spine System - K024348 and K0 10576 VSP System - K9843 50 TJMX System - K98 1274 Summary of Technological Differences… | 2001 |
| * | K984350 | VSP SystemSummary page 3…ISOLA System - K013)44 1, K0 10972. and K980485 MONARCH Spine System - K024348 and K0 10576 VSP System - K9843 50 TJMX System - K98 1274 Summary of Technological Differences: The purpose of this submission is… | 1999 |
| * | K981274 | Acromed Timx Plate Based Low Back SystemSummary page 3…0972. and K980485 MONARCH Spine System - K024348 and K0 10576 VSP System - K9843 50 TJMX System - K98 1274 Summary of Technological Differences: The purpose of this submission is to obtain market clearance for… | 1998 |
What descends from it? (260)
See all 2605 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2015 | Class II | Z-1674-2015 | Process design | Device does not mate as intended. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 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.
- 2 of the 77 ancestors have a recall of any class.
- Of its descendants, K122226 (Globus Medical, Inc., 2012) has gone furthest, with 225 descendants of its own.
- 1 other device also cites its predicate K092473.
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 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…
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/K101070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101070: 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/K101070
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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