510(k) Report

510(k) · Cleared

Cleared

Caspian OCT/MESA Mini/DENALI Mini Spinal System

K142558510(k) SpecialCleared Dec 22, 2014102-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 · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 22, 2014 as substantially equivalent to K101084 (K2m, Inc., 2010) and 4 other predicates after a 102-day review. Its family tree reaches back 12 generations to 1985.

Decided
Dec 22, 2014
Review
102 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
5

Its longest line of descent runs back 12 generations to K853033 (1985). 33 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2009: 2 other ancestors2008: 2 other ancestors2004: 4 other ancestors2011: 1 other ancestor2007: 1 other ancestor2003: 2 other ancestors1999: 4 other ancestors2002: 2 other ancestors2001: 2 other ancestors2000: 1 other ancestorK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K050391 · Protex CT Cervicothoracic Spinal System · Globus Medical, Inc. · 2005×2: 2 generations cleared close together, K101084 (2010), K103232 (2011) K121808 · Casian, 3.5/4.5 Connectors · K2m, Inc. · 20121985199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 12 other ancestors4 generations back: 2 other ancestors K121808 · Casian, 3.5/4.5 Connectors · K2m, Inc. · 2012K103232 · Caspian Spinal System · K2m, Inc. · 2011K101084 · Caspian Spinal System · K2m, Inc. · 2010K050391 · Protex CT Cervicothoracic Spinal System · Globus Medical, Inc. · 2005K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−10−50
  1. Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 8 generations between
  3. 3 generations backK101084 Caspian Spinal SystemK2m, Inc. · 2010
  4. 2 generations backK103232 Caspian Spinal SystemK2m, Inc. · 2011
  5. 1 generation backK121808 Casian, 3.5/4.5 ConnectorsK2m, Inc. · 2012
  6. This deviceK142558 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m · 2014
Show all 12 generations
  1. Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 4 generations backK050391 Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc. · 2005
  10. 3 generations backK101084 Caspian Spinal SystemK2m, Inc. · 2010
  11. 2 generations backK103232 Caspian Spinal SystemK2m, Inc. · 2011
  12. 1 generation backK121808 Casian, 3.5/4.5 ConnectorsK2m, Inc. · 2012
  13. This deviceK142558 Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−11K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−10K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−9K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−8K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−7K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−6K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−5K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−4K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005—
−3K101084Caspian Spinal SystemK2m, Inc.2010—
−2K103232Caspian Spinal SystemK2m, Inc.2011—
−1K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.2012—
0 (this device)K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199940
200010
200120
200220
200320
200440
200710
200820
200920
201110
FIG. 1 — Lineage of K142558, 1985–2014Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K101084Caspian Spinal System
Summary page 4
…): Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050, Product Code KWP) Predicate Device(s) Primary Predicate K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084) Additional Predicates K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K092640, K081107, K121808) Biomet Altius (K033961)…
K2m, Inc.2010—
*K092640Caspian Spinal System
Summary page 4
…cate Device(s) Primary Predicate K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084) Additional Predicates K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K092640, K081107, K121808) Biomet Altius (K033961) Device Description The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loa…
K2m, Inc.2009—
*K081107Caspian Spinal System, Screws, Rods, Hooks, Rod Connectors
Summary page 4
…ce(s) Primary Predicate K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084) Additional Predicates K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K092640, K081107, K121808) Biomet Altius (K033961) Device Description The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loading, mul…
K2m, Inc.2008—
*K121808Casian, 3.5/4.5 Connectors
Summary page 4
…mary Predicate K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K101084) Additional Predicates K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K092640, K081107, K121808) Biomet Altius (K033961) Device Description The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loading, multiple com…
K2m, Inc.2012—
*K033961Altius Oct System
Summary page 4
…an OCT/MESA Mini/DENALI Mini Spinal System (K101084) Additional Predicates K2M Caspian OCT/MESA Mini/DENALI Mini Spinal System (K092640, K081107, K121808) Biomet Altius (K033961) Device Description The Caspian OCT/MESA Mini/ DENALI Mini Spinal System is a top-loading, multiple component, posterior (occip…
Interpore Cross Intl.2004—

Also cleared against K101084: 5 other devices →

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 29 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
  • 1 of the 33 ancestors has a recall of any class.
  • 5 other devices also cite its predicate K101084.

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. 2014, 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 OCT/MESA Mini/DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and 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…

Read the full statement (152 words)

The Caspian OCT/MESA Mini/DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and 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, atlantoaxial fracture with instability, occipitocervical dislocation. The occipital bone screws are limited to occipital fixation only. 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 the 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 OCT/MESA Mini/DENALI Mini Spinal System can also be linked to the RANGE® Spinal System using rod connectors or transitional rods.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K101084

5 other devices cite the same predicate.

  • K171444YUKON OCT Spinal SystemK2m, Inc. · 20173 recalls
  • K141284Caspian Spinal SystemK2m, Inc. · 2014
  • K133288Caspian Oct Spinal SystemK2m, Inc. · 2014
  • K113654CaspianK2m, Inc. · 2012
  • K103232Caspian Spinal SystemK2m, Inc. · 2011

More from K2m

16 FDA decisions under this applicant name. See the company

  • K182182YUKON OCT Spinal SystemK2m · 2018
  • K181890Brainlab Compatible K2M Navigation InstrumentsK2m · 2018
  • K172941CASCADIA Interbody SystemK2m · 2018
  • K171556K2M Navigation InstrumentsK2m · 2018
  • K173508Everest Spinal SystemK2m · 2018

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • 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/K142558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142558: Caspian OCT/MESA Mini/DENALI Mini 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/K142558

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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