510(k) · Cleared
ClearedNex-Link Spinal Fixation System Offset Connectors, 2121-XX Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Spine, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Sep 26, 2006 as substantially equivalent to K031985 (Spinal Concepts, Inc., 2003) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Sep 26, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011969 (2001). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011969 Synthes Cervifix SystemSynthes (Usa) · 2001
- 1 generation backK021009 Octafix Occipital Cervical Plating SystemSpinal Concepts, Inc. · 2002
- This deviceK062505 Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesAbbott Spine, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK113346 Neon SystemUlrich GmbH & Co. KG · 2012
- Descendant · 2 generations on · 0 of its ownK230614 Cortium™Ulrich Medical USA · 2023
- Descendant · cites it directly · 0 of its ownK142752 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal…Zimmer Spine, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011969 | Synthes Cervifix System | Synthes (Usa) | 2001 | — |
| −1 | K021009 | Octafix Occipital Cervical Plating System | Spinal Concepts, Inc. | 2002 | — |
| 0 (this device) | K062505 | Nex-Link Spinal Fixation System Offset Connectors, 2121-XX Series | Abbott Spine, Inc. | 2006 | — |
| +1 | K113346 | Neon System | Ulrich GmbH & Co. KG | 2012 | — |
| +2 | K230614 | Cortium™ | Ulrich Medical USA | 2023 | — |
| +1 | K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation… | Zimmer Spine, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 MNI? 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? (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 |
|---|---|---|---|
| * | K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemSummary page 1…nal System CLASSIFICATION REFERENCE: 21 CFR § 888.3050, 888.3070 PREDICATE DEVICE SYSTEM(S): The Nex-Link Spinal Fixation System, K031985, cleared on September HI, 2003. The… | 2003 |
| * | K021009 | Octafix Occipital Cervical Plating SystemSummary page 1…leared on September HI, 2003. The OctaFix Occipital Cervical Plating System, K021009, cleared on June 18, 2002. DEVICE DESCRIPTION: The Nex-Link Spinal Fixation System is intended for fixation to, and stabilizatio… | 2002 |
What descends from it? (3)
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 5 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K113346 (Ulrich GmbH & Co. KG, 2012) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K031985.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When intended to promote fusion of the cervical spine and tie thoracic spine, (Cl-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylohsthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hlooks and rods are also intended to provide stabilization to promote fusion followng…
Read the full statement (104 words)
When intended to promote fusion of the cervical spine and tie thoracic spine, (Cl-T3), the NexLink Spinal Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylohsthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hlooks and rods are also intended to provide stabilization to promote fusion followng reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.
The use of multiaxial screws is limited to placement in Tl-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062505 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062505: Nex-Link Spinal Fixation System Offset Connectors, 2121-XX Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062505
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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