510(k) · Cleared
ClearedNEX-D2 Posterior Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Next Orthosurgical · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 15, 2020 as substantially equivalent to K141291 (Next Orthosurgical, 2014) and 3 other predicates after a 275-day review. Its family tree reaches back 16 generations to 1985.
- Decided
- Jan 15, 2020
- Review
- 275 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K853033 (1985). 151 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations between
- 3 generations backK130877 Expedium Spine SystemMedos International SARL · 2013
- 2 generations backK141291 Vertiform Posterior Fixation SystemNext Orthosurgical · 2014
- 1 generation backK161499 VertiForm Posterior Fixation SystemNext Orthosurgical · 2016
- This deviceK190981 NEX-D2 Posterior Fixation SystemNext Orthosurgical · 2020
Show all 16 generations
- Root · 16 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 15 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 14 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 13 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 12 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 11 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 10 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 9 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 8 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 7 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 5 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- 3 generations backK130877 Expedium Spine SystemMedos International SARL · 2013
- 2 generations backK141291 Vertiform Posterior Fixation SystemNext Orthosurgical · 2014
- 1 generation backK161499 VertiForm Posterior Fixation SystemNext Orthosurgical · 2016
- This deviceK190981 NEX-D2 Posterior Fixation SystemNext Orthosurgical · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −15 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −14 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −13 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −12 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −11 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −10 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −9 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −8 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −7 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −5 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| −3 | K130877 | Expedium Spine System | Medos International SARL | 2013 | — |
| −2 | K141291 | Vertiform Posterior Fixation System | Next Orthosurgical | 2014 | — |
| −1 | K161499 | VertiForm Posterior Fixation System | Next Orthosurgical | 2016 | — |
| 0 (this device) | K190981 | NEX-D2 Posterior Fixation System | Next Orthosurgical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 10 | 0 |
| 2001 | 16 | 0 |
| 2002 | 8 | 0 |
| 2003 | 10 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K141291 | Vertiform Posterior Fixation SystemSummary page 4…1 CFR 888.3070 Device panel: Orthopedic Legally Marketed Predicate Device: Next Orthosurgical, VertiForm Posterior Fixation System, K141291 (Primary Predicate) Next Orthosurgical, VertiForm Posterior Fixat… | 2014 |
| * | K161499 | VertiForm Posterior Fixation SystemSummary page 4…ior Fixation System, K141291 (Primary Predicate) Next Orthosurgical, VertiForm Posterior Fixation System, K161499 DePuy Moss Miami Spinal System Polyaxial Screws, K030383 Spinal E… | 2016 |
| * | K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsSummary page 4…Next Orthosurgical, VertiForm Posterior Fixation System, K161499 DePuy Moss Miami Spinal System Polyaxial Screws, K030383 Spinal Elements Mercury Spinal System, K172967 The predicates ha… | 2003 |
| * | K172967 | Mercury® Spinal SystemSummary page 4…, K161499 DePuy Moss Miami Spinal System Polyaxial Screws, K030383 Spinal Elements Mercury Spinal System, K172967 The predicates have not been subject to a design related recall. Date Prepared: 1/10/2020… | 2018 |
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 35 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 151 ancestors have a recall of any class.
- 1 other device also cites its predicate K141291.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 NEX-D2 Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis (previous…
Read the full statement (98 words)
The NEX-D2 Posterior Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients for the following conditions: degenerative disc disease (DDD), DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis (previous failed fusion). When used as posterior non-cervical pedicle screw fixation in pediatric patients, the NEX-D2 Posterior Fixation System is intended to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and or allograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190981: NEX-D2 Posterior Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190981
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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