510(k) Report

510(k) · Cleared

Cleared

Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors

K081107510(k) TraditionalCleared Oct 10, 2008175-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 Oct 10, 2008 after a 175-day review. The FDA summary names its predicate without a number. 64 later devices descend from it.

Decided
Oct 10, 2008
Review
175 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

64 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2015: 6 descendants cleared2014: 9 descendants cleared2012: 3 descendants cleared2010: 1 descendant cleared2013: 3 descendants cleared2016: 5 descendants cleared2017: 3 descendants cleared2011: 1 descendant cleared2024: 8 descendants cleared2021: 1 descendant cleared2018: 7 descendants cleared2020: 4 descendants cleared2022: 3 descendants cleared2026: 5 descendants cleared2023: 3 descendants cleared2025: 2 descendants cleared20052010201520202025
  1. This deviceK081107 Caspian Spinal System, Screws, Rods, Hooks, Rod ConnectorsK2m, Inc. · 2008
  2. Descendant · cites it directly · 62 of its ownK101084 Caspian Spinal SystemK2m, Inc. · 2010
  3. Descendant · cites it directly · 46 of its ownK103232 Caspian Spinal SystemK2m, Inc. · 2011
  4. Descendant · cites it directly · 44 of its ownK113654 CaspianK2m, Inc. · 2012
  5. Descendant · cites it directly · 43 of its ownK120656 Everest Spinal SystemK2m, Inc. · 2012
  6. Descendant · 2 generations on · 41 of its ownK132757 Everest Spinal SystemK2m, Inc. · 2013

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 32013: 32014: 92015: 62016: 52017: 32018: 72020: 42021: 12022: 32023: 32024: 82025: 22026: 5
2010high 9 (2014) · low 0 (2019)2026

Most influential descendants

Showing 5 of 64 · See all
  • K101084Caspian Spinal SystemK2m, Inc. · 2010 · cites it directly62descendants
  • K103232Caspian Spinal SystemK2m, Inc. · 2011 · cites it directly46descendants
  • K113654CaspianK2m, Inc. · 2012 · cites it directly44descendants
  • K120656Everest Spinal SystemK2m, Inc. · 2012 · cites it directly43descendants
  • K132757Everest Spinal SystemK2m, Inc. · 2013 · 2 generations on41descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K081107Caspian Spinal System, Screws, Rods, Hooks, Rod ConnectorsK2m, Inc.2008—
+1K101084Caspian Spinal SystemK2m, Inc.2010—
+1K103232Caspian Spinal SystemK2m, Inc.2011—
+1K113654CaspianK2m, Inc.2012—
+1K120656Everest Spinal SystemK2m, Inc.2012—
+2K132757Everest Spinal SystemK2m, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201230
201330
201490
201560
201650
201730
201870
202040
202110
202230
202330
202480
202520
202650
FIG. 1 — Lineage of K081107, 2008–2026Source: 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? (4)

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
*—Synthes Starlock/Cervifix
Named without a submission number
—
*—Interpore Mini VLS/Altius
Named without a submission number
—
*—DePuy Mountaineer
Named without a submission number
—
*—Spinal Concepts Octafix
Named without a submission number
—

What descends from it? (64)

See all 64

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

NumberDeviceApplicantDecidedDescendants
K101084Caspian Spinal SystemK2m, Inc.201062
K103232Caspian Spinal SystemK2m, Inc.201146
K113654CaspianK2m, Inc.201244
K120656Everest Spinal SystemK2m, Inc.201243
K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617
K171444YUKON OCT Spinal SystemK2m, Inc.201713
K151727Everest Spinal SystemK2m, Inc.201511
K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121
K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140
K141284Caspian Spinal SystemK2m, Inc.20140

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, K101084 (K2m, Inc., 2010) has gone furthest, with 62 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. 2008, 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 Hooks and Rods-The rod and hook components are also intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following…

Read the full statement (145 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

Hooks and Rods-The rod and hook components are also intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods and Pedicle Screws-The rods and screws are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

Indications for use as stated in the FDA summary.

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

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  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

Recent decisions in KWP

The KWP category page

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  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K081107 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081107: Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081107

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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