510(k) · Cleared
ClearedAnnextm Adjacent Level System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Wave, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jan 10, 2014 as substantially equivalent to K070245 (Spine Wave, Inc., 2007) and 3 other predicates after a 162-day review. Its family tree reaches back 14 generations to 1985. 2 later devices descend from it.
- Decided
- Jan 10, 2014
- Review
- 162 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K853033 (1985). 193 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 1 generation backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- This deviceK132403 Annextm Adjacent Level SystemSpine Wave, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK251131 Annex® 2 Adjacent Level SystemSpine Wave, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK232719 ProMIS Extension Rod SystemPremia Spine, Ltd. · 2023
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 1 generation backK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- This deviceK132403 Annextm Adjacent Level SystemSpine Wave, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −1 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K132403 | Annextm Adjacent Level System | Spine Wave, Inc. | 2014 | — |
| +1 | K251131 | Annex® 2 Adjacent Level System | Spine Wave, Inc. | 2025 | — |
| +1 | 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 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 7 | 0 |
| 2003 | 11 | 0 |
| 2004 | 22 | 0 |
| 2005 | 22 | 0 |
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 11 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K070245 | Capsure Pedicle Screw SystemSummary page 1…following predicates: Predicate Device, Manufacturer 510(k) No. ICapSure® PS System ISpine Wave, Inc. K070245, K 132154 Revere® Stabilization Systenm Globus Medical, Inc. K122226 Synerg VLS Spine Sstem Interpore… | 2007 |
| * | K132154 | Capsure PS System Cleared while this submission was under review Summary page 1…g predicates: Predicate Device, Manufacturer 510(k) No. ICapSure® PS System ISpine Wave, Inc. K070245, K 132154 Revere® Stabilization Systenm Globus Medical, Inc. K122226 Synerg VLS Spine Sstem Interpore Cross Int… | 2013 |
| * | K122226 | Revere Stabilization SystemSummary page 1…510(k) No. ICapSure® PS System ISpine Wave, Inc. K070245, K 132154 Revere® Stabilization Systenm Globus Medical, Inc. K122226 Synerg VLS Spine Sstem Interpore Cross International K01 1437 5. Device Description The AnnexTM Adjacent Leve… | 2012 |
| * | K011437 | Synergy 4.0 MM, 4.5 MM VLS ScrewsSummary page 1…K070245, K 132154 Revere® Stabilization Systenm Globus Medical, Inc. K122226 Synerg VLS Spine Sstem Interpore Cross International K01 1437 5. Device Description The AnnexTM Adjacent Level System consists of a selection of non-sterile, single use connectors man… | 2001 |
What descends from it? (2)
2 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 29 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 193 ancestors have a recall of any class.
- Of its descendants, K251131 (Spine Wave, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K070245.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When used with pedicle screw fixation systems of the noncervical spine in skeletally mature patients, the Annex h Adjacent Level System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Annex h Adjacent Level System is also indicated for pedicle screw fixation in skeletally mature patients with severe…
Read the full statement (133 words)
When used with pedicle screw fixation systems of the noncervical spine in skeletally mature patients, the Annex h Adjacent Level System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Annex h Adjacent Level System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-SI vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S 1), and for whom the device is intended to be removed after solid fusion is attained.
The Annexm Adjacent Level System can be linked to 5.5mm diameter rod systems, including the CapSure®1 or Sniper(1) Spine Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132403 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132403: Annextm Adjacent Level System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132403
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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