510(k) · Cleared
Recalled · 2005Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119, 2120. Nex-Link Spinal Fixation SY
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 Jan 6, 2006 as substantially equivalent to K031985 (Spinal Concepts, Inc., 2003) after a 109-day review. Its family tree reaches back 1 generation to 2003. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 6, 2006
- Review
- 109 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031985 (2003). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK031985 Spinal Concepts Inc. Nex-Link Spinal Fixation SystemSpinal Concepts, Inc. · 2003 · Recalled
- This deviceK052566 Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112…Abbott Spine, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK113346 Neon SystemUlrich GmbH & Co. KG · 2012
- Descendant · cites it directly · 1 of its ownK060634 Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725…Abbott Spine, Inc. · 2006 · Recalled
- 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 4 of 4 · See all- K113346Neon SystemUlrich GmbH & Co. KG · 2012 · cites it directly1descendant
- K060634Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 SeriesAbbott Spine, Inc. · 2006 · cites it directly1descendant
- K230614Cortium™Ulrich Medical USA · 2023 · 2 generations on0descendants
- K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation System | Spinal Concepts, Inc. | 2003 | 4 |
| 0 (this device) | K052566 | Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113… | Abbott Spine, Inc. | 2006 | — |
| +1 | K113346 | Neon System | Ulrich GmbH & Co. KG | 2012 | — |
| +1 | K060634 | Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 Series | Abbott Spine, Inc. | 2006 | 4 |
| +2 | K230614 | Cortium™ | Ulrich Medical USA | 2023 | — |
| +1 | K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation… | Zimmer Spine, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (1)
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…PREDICATE DEVICE: Spinal Concepts, Inc. (now Abbott Spine, Inc.) Nex-Link Spinal Fixation System, K03 1985, cleared September 11, 2003. DEVICE DESCRIPTION: The Nex-Link Spinal Fixation Syste… | 2003 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2005 | Not classified | Z-0605-2011 | Device Design | The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site. |
| Dec 1, 2005 | Not classified | Z-0602-2011 | Device Design | The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site. |
| Dec 1, 2005 | Not classified | Z-0603-2011 | Device Design | The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site. |
| Dec 1, 2005 | Not classified | Z-0604-2011 | Device Design | The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 the thoracic spine, (CI-T3), the Nex-Link 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), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and rods are also intended to provide stabilization to promote fusion following…
Read the full statement (104 words)
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the Nex-Link 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), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (CI-T3) spine.
The use of multiaxial screws is limited to placement in TI-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/K052566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052566: Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119, 2120. Nex-Link Spinal Fixation SY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052566
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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