510(k) · Cleared
ClearedAnnex® 2 Adjacent Level System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 6, 2025 as substantially equivalent to K132403 (Spine Wave, Inc., 2014) and 1 other predicate after a 56-day review. Its family tree reaches back 22 generations to 1985. 1 of the 226 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 6, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K853033 (1985). 225 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 226 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 18 generations between
- 3 generations backK202476 Salvo® Spine SystemSpine Wave, Inc. · 2020
- 2 generations backK222362 Salvo® Spine SystemSpine Wave, Inc. · 2022
- 1 generation backK240685 Salvo® Spine SystemSpine Wave, Inc. · 2024
- This deviceK251131 Annex® 2 Adjacent Level SystemSpine Wave, Inc. · 2025
Show all 22 generations
- Root · 22 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 21 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 20 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 19 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 18 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 17 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 16 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 15 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 14 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 13 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 12 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 11 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 10 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 9 generations backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- 8 generations backK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- 7 generations backK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- 6 generations backK180210 CREO® Stabilization SystemGlobus Medical, Inc. · 2018
- 5 generations backK182954 Salvo™ Spine SystemSpine Wave, Inc. · 2018
- 4 generations backK191045 Salvo™ Spine SystemSpine Wave, Inc. · 2019
- 3 generations backK202476 Salvo® Spine SystemSpine Wave, Inc. · 2020
- 2 generations backK222362 Salvo® Spine SystemSpine Wave, Inc. · 2022
- 1 generation backK240685 Salvo® Spine SystemSpine Wave, Inc. · 2024
- This deviceK251131 Annex® 2 Adjacent Level SystemSpine Wave, Inc. · 2025
Class I recalls in this family
- K100952 Modification to Synthes Matrix System8 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −21 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −20 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −19 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −18 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −17 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −16 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −15 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −14 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −13 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −12 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −11 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −10 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −9 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| −8 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| −7 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| −6 | K180210 | CREO® Stabilization System | Globus Medical, Inc. | 2018 | — |
| −5 | K182954 | Salvo™ Spine System | Spine Wave, Inc. | 2018 | — |
| −4 | K191045 | Salvo™ Spine System | Spine Wave, Inc. | 2019 | — |
| −3 | K202476 | Salvo® Spine System | Spine Wave, Inc. | 2020 | — |
| −2 | K222362 | Salvo® Spine System | Spine Wave, Inc. | 2022 | — |
| −1 | K240685 | Salvo® Spine System | Spine Wave, Inc. | 2024 | — |
| 0 (this device) | K251131 | Annex® 2 Adjacent Level System | Spine Wave, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 9 | 0 |
| 2003 | 12 | 0 |
| 2004 | 23 | 0 |
| 2005 | 22 | 0 |
| 2006 | 10 | 0 |
| 2007 | 10 | 0 |
| 2008 | 12 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 1 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 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? (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 |
|---|---|---|---|
| * | K132403 | Annextm Adjacent Level SystemSummary page 5…888.3070 Product Code(s) NKB | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K132403 Annex® Adjacent Level System MNH K240685 Salvo® Spine System NKB Device Description Summary 21 CFR 807.92(a)(4) The Annex® 2 Adj… | 2014 |
| * | K240685 | Salvo® Spine SystemSummary page 5…Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K132403 Annex® Adjacent Level System MNH K240685 Salvo® Spine System NKB Device Description Summary 21 CFR 807.92(a)(4) The Annex® 2 Adjacent Level System consists of a selectio… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 8 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 20 of the 225 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K132403.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 pedicle screw fixation systems, the Annex® 2 Adjacent Level System is intended to provide
immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of
the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc
disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion
(pseudarthrosis).
The Annex® 2 Adjacent Level System can be linked to 4.75 mm, 5.5 mm, and/or 6.0 mm diameter rods of the following
systems: CapSure®, Sniper® or Salvo® Spine Systems.
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/K251131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251131: Annex® 2 Adjacent Level System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251131
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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