510(k) · Cleared
ClearedPathfinder NXT Minimally Invasive Pedicle Screw 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 Nov 25, 2013 as substantially equivalent to K100845 (Zimmer Spine, Inc., 2010) and 3 other predicates after a 73-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Nov 25, 2013
- Review
- 73 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K950697 (1995). 43 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.
- Root · 8 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 4 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 3 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- 1 generation backK100845 Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500…Zimmer Spine, Inc. · 2010 · Recalled
- This deviceK132884 Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −7 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −4 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −3 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| −1 | K100845 | Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 Series | Zimmer Spine, Inc. | 2010 | 5 |
| 0 (this device) | K132884 | Pathfinder NXT Minimally Invasive Pedicle Screw System | Zimmer Spine, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K100845 | Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesSummary page 1…ve PedicleK167Juy8.22 Screw System K217 uy1,21 PathFinder NXT® Minimally Invasive Pedicle K1 00845 September 21, 2010 Screw System _______ __________… | 2010 |
| * | K082032 | Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309…Summary page 2…e Device NameIDNme Sequoia® Pedicle Screw System includingK022 Ocoe6,08 SpeedLink IITm Transverse Connector System K082032___ October 6, 2008__ Synergy 02 Spinal Implant K984578 March 23, 1999 T… | 2008 |
| * | K984578 | Synergy D2 Spinal ImplantsSummary page 2…Ocoe6,08 SpeedLink IITm Transverse Connector System K082032___ October 6, 2008__ Synergy 02 Spinal Implant K984578 March 23, 1999 Titanium TSRH® Spinal System (Screws) K946348 August 7, 1995 Genera… | 1999 |
| * | K946348 | Titanium TSRH (R) Spinal System (Screws)Summary page 2…6, 2008__ Synergy 02 Spinal Implant K984578 March 23, 1999 Titanium TSRH® Spinal System (Screws) K946348 August 7, 1995 General Device Description: The existing, commercially available Zimmer Spine PathFinder NXT@ Minimal… | 1995 |
| * | — | PathFinder NXT® Minimally Invasive Pedicle Screw System Named without a submission number |
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 18 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 7 of the 43 ancestors have a recall of any class.
- 2 other devices also cite its predicate K100845.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 for pedicle screw fixation from TI-Si, the indications include 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…
Read the full statement (129 words)
When intended for pedicle screw fixation from TI-Si, the indications include 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.
As a pedicle screw system placed between L3 and Si, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autograft or allograft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132884: Pathfinder NXT Minimally Invasive Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132884
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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