510(k) · Cleared
Recalled · 2010Spinal Concepts Inc. Pathfinder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Concepts, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 28, 2003 as substantially equivalent to K021564 (Spinal Concepts, Inc., 2002) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2002. 109 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 28, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021564 (2002). 109 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK021564 Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002 · Recalled
- 1 generation backK023644 Modification to Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002 · Recalled
- This deviceK030625 Spinal Concepts Inc. PathfinderSpinal Concepts, Inc. · 2003
- Descendant · cites it directly · 94 of its ownK071174 Pathfinder System Polyaxial Pedicle ScrewsAbbott Spine, Inc. · 2007 · Recalled
- Descendant · cites it directly · 93 of its ownK113044 Synthes MirsSynthes Spine · 2011 · Recalled
- Descendant · 2 generations on · 74 of its ownK120571 Synthes Uss ConnectorSynthes Spine · 2012
- Descendant · 3 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- Descendant · 4 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K071174Pathfinder System Polyaxial Pedicle ScrewsAbbott Spine, Inc. · 2007 · cites it directly94descendants
- K113044Synthes MirsSynthes Spine · 2011 · cites it directly93descendants
- K120571Synthes Uss ConnectorSynthes Spine · 2012 · 2 generations on74descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 3 generations on67descendants
- K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021564 | Incompass Spinal Fixation System | Spinal Concepts, Inc. | 2002 | 1 |
| −1 | K023644 | Modification to Incompass Spinal Fixation System | Spinal Concepts, Inc. | 2002 | 1 |
| 0 (this device) | K030625 | Spinal Concepts Inc. Pathfinder | Spinal Concepts, Inc. | 2003 | — |
| +1 | K071174 | Pathfinder System Polyaxial Pedicle Screws | Abbott Spine, Inc. | 2007 | 4 |
| +1 | K113044 | Synthes Mirs | Synthes Spine | 2011 | 3 |
| +2 | K120571 | Synthes Uss Connector | Synthes Spine | 2012 | — |
| +3 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| +4 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 13 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 9 | 0 |
| 2024 | 12 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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? (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 |
|---|---|---|---|
| * | K021564 | Incompass Spinal Fixation System | 2002 |
| * | K023644 | Modification to Incompass Spinal Fixation SystemSummary page 1…nal Concepts Inc. PathFinder PREDICATE DEVICE Spinal Concepts Inc. InCompass Spinal Fixation System (KO2 1564 and K023644). This is a design modification per established design control… | 2002 |
What descends from it? (109)
See all 1096 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071174 | Pathfinder System Polyaxial Pedicle Screws | 2007 | 94 |
| K113044 | Synthes Mirs | 2011 | 93 |
| K062670 | Vertiflex Spinal Screw System | 2007 | 12 |
| K100845 | Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 Series | 2010 | 4 |
| K121130 | Polaris Spinal System-Ballista Spinal Rods | 2012 | 1 |
| K042640 | Uni-Thread Spinal System | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2010 | Not classified | Z-0075-2011 | Device Design | The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip. |
| Jan 12, 2009 | Not classified | Z-2335-2010 | Other | The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site. |
| Apr 17, 2008 | Not classified | Z-1784-2008 | Device Design | Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing.… |
| Mar 24, 2008 | Not classified | Z-1593-2008 | Error in labeling | Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site. |
| Jul 18, 2007 | Not classified | Z-0004-2008 | Device Design | Tip of PathFinder surgical instrument broke during procedure. |
| Jul 18, 2007 | Not classified | Z-0005-2008 | Device Design | Tip of PathFinder surgical instrument broke during procedure. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 4 months on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K071174 (Abbott Spine, Inc., 2007) has gone furthest, with 94 descendants of its own.
- 6 other devices also cite its predicate K021564.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
PathFinder - Mini-Open Posterior Approach When intended for pedicle screw fixation from L1-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…
Read the full statement (203 words)
PathFinder - Mini-Open Posterior Approach
When intended for pedicle screw fixation from L1-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 autologous bone graft, when
affixed to the posterior lumbosacral spine, and intended to be removed after solid
fusion is established.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030625 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030625: Spinal Concepts Inc. Pathfinder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030625
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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