510(k) · Cleared
Recalled · Class II · 2012Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 Series
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 Sep 21, 2010 as substantially equivalent to K082032 (Abbott Spine, Inc., 2008) and 2 other predicates after a 180-day review. Its family tree reaches back 7 generations to 1995. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 21, 2010
- Review
- 180 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 7 generations to K950697 (1995). 40 ancestors in all, the oldest K933881 (1994). 4 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 4 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 3 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 2 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- This deviceK100845 Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500…Zimmer Spine, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK121130 Polaris Spinal System-Ballista Spinal RodsBiomet Spine · 2012
- Descendant · cites it directly · 0 of its ownK132884 Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK123451 Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC) · 2012
- Descendant · cites it directly · 0 of its ownK121671 Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine · 2012 · cites it directly1descendant
- K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc. · 2013 · cites it directly0descendants
- K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC) · 2012 · 2 generations on0descendants
- K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −6 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −4 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −3 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −2 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −1 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| 0 (this device) | K100845 | Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 Series | Zimmer Spine, Inc. | 2010 | — |
| +1 | K121130 | Polaris Spinal System-Ballista Spinal Rods | Biomet Spine | 2012 | — |
| +1 | K132884 | Pathfinder NXT Minimally Invasive Pedicle Screw System | Zimmer Spine, Inc. | 2013 | — |
| +2 | K123451 | Polaris Spinal System - Ballista II Rods | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| +1 | K121671 | Pathfinder NXT Minimally Invasive Pedicle Screw System | Zimmer Spine, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K082032 | Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models 3308, 3309…Summary page 1…NKB - 21 CFR § 888.3070 - Spinal Interlaminal Fixation Orthosis Predicate Device Information Sequoia Pedicle Screw System, K082032 (S.E. 10/7/2008) PathFinder Minimally Invasive Pedicle Screw System, K030625 (S.E.3/28/2003) Depuy Viper 1I, K090648 (S.E. 6/10/0… | 2008 |
| * | K030625 | Spinal Concepts Inc. PathfinderSummary page 1…Predicate Device Information Sequoia Pedicle Screw System, K082032 (S.E. 10/7/2008) PathFinder Minimally Invasive Pedicle Screw System, K030625 (S.E.3/28/2003) Depuy Viper 1I, K090648 (S.E. 6/10/09) Device Description and Technological Characteristics: The purpose of th… | 2003 |
| * | K090648 | Viper 2 SystemSummary page 1…ate Device Information Sequoia Pedicle Screw System, K082032 (S.E. 10/7/2008) PathFinder Minimally Invasive Pedicle Screw System, K030625 (S.E.3/28/2003) Depuy Viper 1I, K090648 (S.E. 6/10/09) Device Description and Technological Characteristics: The purpose of this 5 10(k) submission is to modernize th… | 2009 |
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 |
|---|---|---|---|---|
| Jun 5, 2012 | Class II | Z-1981-2012 | Device Design | Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery. |
| Jun 5, 2012 | Class II | Z-1980-2012 | Device Design | Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery. |
| Jun 5, 2012 | Class II | Z-1933-2012 | Device Design | Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and… |
| May 20, 2011 | Not classified | Z-2723-2011 | Device Design | Zimmer Spine, Inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) Closure Top Driver used for insertion, provisional tightening, and… |
| May 20, 2011 | Not classified | Z-2722-2011 | Device Design | Zimmer Spine, Inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) Closure Top Driver used for insertion, provisional tightening, and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 6 of the 40 ancestors have a recall of any class.
- Of its descendants, K121130 (Biomet Spine, 2012) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K082032.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 T1-S1, 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 (128 words)
When intended for pedicle screw fixation from T1-S1, 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 S1, 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 solid fusion is established.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100845 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100845: Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100845
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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