510(k) · Cleared
ClearedProMIS Extension Rod System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premia Spine, Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 21, 2023 as substantially equivalent to K231844 (Premia Spine, Ltd., 2023) and 1 other predicate after a 77-day review. Its family tree reaches back 15 generations to 1985.
- Decided
- Nov 21, 2023
- Review
- 77 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K853033 (1985). 256 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 2 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 1 generation backK132403 Annextm Adjacent Level SystemSpine Wave, Inc. · 2014
- This deviceK232719 ProMIS Extension Rod SystemPremia Spine, Ltd. · 2023
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 2 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 1 generation backK132403 Annextm Adjacent Level SystemSpine Wave, Inc. · 2014
- This deviceK232719 ProMIS Extension Rod SystemPremia Spine, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −2 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −1 | K132403 | Annextm Adjacent Level System | Spine Wave, Inc. | 2014 | — |
| 0 (this device) | K232719 | ProMIS Extension Rod System | Premia Spine, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 13 | 0 |
| 1999 | 10 | 0 |
| 2000 | 19 | 0 |
| 2001 | 19 | 0 |
| 2002 | 16 | 0 |
| 2003 | 19 | 0 |
| 2004 | 24 | 0 |
| 2005 | 22 | 0 |
| 2006 | 10 | 0 |
| 2007 | 13 | 0 |
| 2008 | 14 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K231844 | ProMIS™ Fixation SystemSummary page 4…ion Rod System 21 C.F.R 888.3070 Thoracolumbosacral pedicle screw system NKB – Class II Predicate Devices Primary Predicate: ProMIS™ Fixation System by Premia Spine (K231844) Additional Predicate: Annex™ Adjacent Level System by Spine Wave (K132403) Intended Use / Indications for Use When used with… | 2023 |
| * | K132403 | Annextm Adjacent Level SystemSummary page 4…KB – Class II Predicate Devices Primary Predicate: ProMIS™ Fixation System by Premia Spine (K231844) Additional Predicate: Annex™ Adjacent Level System by Spine Wave (K132403) Intended Use / Indications for Use When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to p… | 2014 |
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 38 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 23 of the 256 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, for the treatment of the following acute and chronic instabilities or deformities of the lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
Read the full statement (119 words)
When used with the ProMIS Fixation System, the ProMIS Extension Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion, for the treatment of the following acute and chronic instabilities or deformities of the lumbar, and sacral spine: degenerative disc disease (DDD; 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The ProMIS Extension Rod System is compatible with Premia Spine's Slender Tulip Polyaxial Pedicle Screws for extending the ProMIS Fixation System to a single adjacent level.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232719: ProMIS Extension Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232719
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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