510(k) · Cleared
ClearedMinit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 18, 2015 as substantially equivalent to K133291 (Zimmer Spine, Inc., 2013) and 10 other predicates after a 267-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Jun 18, 2015
- Review
- 267 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 6 generations to K014090 (2002). 36 ancestors in all, the oldest K915478 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK014090 Endius Spinal Fixation SystemEndius, Inc. · 2002
- 5 generations backK021881 Endius Title Spinal Fixation SystemEndius, Inc. · 2002
- 4 generations backK041808 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2004 · Recalled
- 3 generations backK060990 Endius Title 2 Poly Axial Spinal SystemEndius, Inc. · 2006
- 2 generations backK070367 Endius Title 2 Polyaxial Spinal SystemEndius, Inc. · 2007
- 1 generation backK133086 Title 2 Polyaxial Spinal SystemZimmer Spine, Inc. · 2013
- This deviceK142752 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal…Zimmer Spine, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K014090 | Endius Spinal Fixation System | Endius, Inc. | 2002 | — |
| −5 | K021881 | Endius Title Spinal Fixation System | Endius, Inc. | 2002 | — |
| −4 | K041808 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | 2004 | 1 |
| −3 | K060990 | Endius Title 2 Poly Axial Spinal System | Endius, Inc. | 2006 | — |
| −2 | K070367 | Endius Title 2 Polyaxial Spinal System | Endius, Inc. | 2007 | — |
| −1 | K133086 | Title 2 Polyaxial Spinal System | Zimmer Spine, Inc. | 2013 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 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? (11)
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 |
|---|---|---|---|
| * | K133291 | ST360 Degrees Spinal Fixation SystemSummary page 10…Code PMA Numbers NKB ST360 K133291 Class III / II 21 CFR § 888.3070 Additional… | 2013 |
| * | K070282 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemSummary page 10…) Numbers Classification Primary Code NKB K070282 Class III / II 21 CFR § 888.3070… | 2007 |
| * | K060683 | Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemSummary page 10…21 CFR § 888.3070 Minit KWP K060683 Class II 21 CFR § 888.3050… | 2006 |
| * | K062505 | Nex-Link Spinal Fixation System Offset Connectors, 2121-XX SeriesSummary page 10…K060683 Class II 21 CFR § 888.3050 K062505 K060634 MNI… | 2006 |
| * | K060634 | Nex-Link Spinal Fixation System Rod to Rod Connectors, Models 725, 726 SeriesSummary page 10…Class II 21 CFR § 888.3050 K062505 K060634 MNI NexLink K052566… | 2006 |
| * | K052566 | Nex-Link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119…Summary page 10…K062505 K060634 MNI NexLink K052566 Class II 21 CFR § 888.3070… | 2006 |
| * | K052247 | Nex-Link Spinal Fixation System Variable Crosslink, Model 721-XXSummary page 10…K052566 Class II 21 CFR § 888.3070 K052247 K031985 KWP… | 2005 |
| * | K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemSummary page 10…Class II 21 CFR § 888.3070 K052247 K031985 KWP NexLink OCT K090060… | 2003 |
| * | K090060 | Nexlink Oct System, Model 7000 SeriesSummary page 10…K052247 K031985 KWP NexLink OCT K090060 Class II 21 CFR § 888.3050 Sequ… | 2009 |
| * | K131980 | Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemSummary page 10…21 CFR § 888.3050 Sequoia NKB K131980 Class III / II (Speedlink) 21 CFR § 888.3070… | 2013 |
| * | K133086 | Title 2 Polyaxial Spinal SystemSummary page 10…21 CFR § 888.3070 Title 2 NKB K133086 Class III / II (Northstar) 21 CFR § 888.3070… | 2013 |
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 13 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 11 of the 36 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic 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 The hooks and rods are also intended to…
Read the full statement (1,107 words)
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic 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
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE 2 System offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-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), 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 T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.
The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.
The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.
When intended for pedicle screw fixation from T1-S1, the Sequoia Pedicle Screw 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
When used as a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient’s general medical condition and the potential risk to the patient of a second surgical procedure.
The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle and nonpedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.
When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.
The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.
The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.
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/K142752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142752: Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142752
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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