510(k) Report

510(k) · Cleared

Cleared

Modification to Caspian Spinal System

K093534510(k) SpecialCleared Dec 16, 200930-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

K2m, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 16, 2009 after a 30-day review. The FDA summary names its predicate without a number. 47 later devices descend from it.

Decided
Dec 16, 2009
Review
30 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

47 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2011: 1 descendant cleared2013: 2 descendants cleared2014: 7 descendants cleared2015: 6 descendants cleared2018: 6 descendants cleared2026: 2 descendants cleared2024: 7 descendants cleared2017: 2 descendants cleared2025: 1 descendant cleared2016: 4 descendants cleared2022: 2 descendants cleared2021: 1 descendant cleared2023: 3 descendants cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK093534 Modification to Caspian Spinal SystemK2m, Inc. · 2009
  2. Descendant · cites it directly · 46 of its ownK103232 Caspian Spinal SystemK2m, Inc. · 2011
  3. Descendant · cites it directly · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
  4. Descendant · 2 generations on · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013
  5. Descendant · 2 generations on · 34 of its ownK132361 Everest Spinal SystemK2m, Inc. · 2013
  6. Descendant · 2 generations on · 33 of its ownK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2011: 12012: 22013: 22014: 72015: 62016: 42017: 22018: 62020: 12021: 12022: 22023: 32024: 72025: 12026: 2
2011high 7 (2014) · low 0 (2019)2026

Most influential descendants

Showing 5 of 47 · See all
  • K103232Caspian Spinal SystemK2m, Inc. · 2011 · cites it directly46descendants
  • K120656Everest Spinal SystemK2m, Inc. · 2012 · cites it directly43descendants
  • K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
  • K132361Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on34descendants
  • K133944Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014 · 2 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K093534Modification to Caspian Spinal SystemK2m, Inc.2009—
+1K103232Caspian Spinal SystemK2m, Inc.2011—
+1K120656Everest Spinal SystemK2m, Inc.2012—
+2K132757Everest Spinal SystemK2m, Inc.2013—
+2K132361Everest Spinal SystemK2m, Inc.2013—
+2K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201220
201320
201470
201560
201640
201720
201860
202010
202110
202220
202330
202470
202510
202620
FIG. 1 — Lineage of K093534, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KWP? 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—K2M Caspian Spinal System
Named without a submission number
—
*—DePuy Mountaineer
Named without a submission number
—
*—Biomet Altius
Named without a submission number
—

What descends from it? (47)

See all 47

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103232Caspian Spinal SystemK2m, Inc.201146
K120656Everest Spinal SystemK2m, Inc.201243

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?

  • Of its descendants, K103232 (K2m, Inc., 2011) has gone furthest, with 46 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

The Caspian Spinal System is indicated for the following: * DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * Spondylolisthesis * Spinal stenosis * Fracture/dislocation * Revision of previous cervical spine surgery * Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of…

Read the full statement (142 words)

The Caspian Spinal System is indicated for the following:

* DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

* Spondylolisthesis

* Spinal stenosis

* Fracture/dislocation

* Revision of previous cervical spine surgery

* Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5Smm rod connectors or transitional rods.

Indications for use as stated in the FDA summary.

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Recent decisions in KWP

The KWP category page

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https://510kreport.com/device/K093534 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093534: Modification to Caspian 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/K093534

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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