510(k) Report

510(k) · Cleared

Cleared

Mountaineer Oct Spinal System

K080828510(k) SpecialCleared Jun 27, 200894-day reviewClass II21 CFR 888.3070

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

Depuy Spine, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jun 27, 2008 as substantially equivalent to K041203 (Depuy Spine, Inc., 2004) and 6 other predicates after a 94-day review. Its family tree reaches back 9 generations to 1985. 1 of the 258 devices in its family, counting itself, has a Class I recall. 242 later devices descend from it.

Decided
Jun 27, 2008
Review
94 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
7

Its longest line of descent runs back 9 generations to K853033 (1985). 15 ancestors in all. 242 later devices descend from it, 8 citing it directly. 1 of the 258 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 1 other ancestor1999: 4 other ancestors2012: 7 descendants cleared2018: 16 descendants cleared2010: 2 descendants cleared2013: 8 descendants cleared2011: 2 descendants cleared2009: 2 descendants cleared2015: 17 descendants cleared2021: 13 descendants cleared, 1 with a Class I recall12020: 18 descendants cleared2022: 16 descendants cleared2019: 10 descendants cleared2014: 15 descendants cleared2017: 13 descendants cleared2016: 8 descendants cleared2023: 19 descendants cleared2025: 21 descendants cleared2026: 25 descendants cleared2024: 30 descendants clearedK853033 · 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 · 2003×2: 2 generations cleared close together, K041203 (2004), K042508 (2004) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors 1 generation forward: 8 descendants2 generations forward: 27 descendants3 generations forward: 36 descendants4 generations forward: 40 descendants5 generations forward: 65 descendants, 1 with a Class I recall16 generations forward: 29 descendants7 generations forward: 20 descendants8 generations forward: 14 descendants9 generations forward: 3 descendants K042508 · Sumit Oct Spinal System and Mountaineer Oct Spinal System · Depuy Spine, Inc. · 2004K041203 · 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. · 1985−50+5
  1. Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 5 generations between
  3. 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  4. 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  5. 1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
  6. This deviceK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008
  7. Descendant · cites it directly · 184 of its ownK103100 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2010
  8. Descendant · cites it directly · 156 of its ownK110353 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011
  9. Descendant · cites it directly · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  10. Descendant · 2 generations on · 98 of its ownK110963 Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc. · 2011
  11. Descendant · 3 generations on · 97 of its ownK123783 Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013
Show all 9 generations
  1. Root · 9 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 8 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 7 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 6 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 5 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 4 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 3 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 2 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 1 generation backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
  10. This deviceK080828 Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2008

Showing 5 of 242 descendants. See all descendants

Descendants cleared per year

2009: 22010: 22011: 22012: 72013: 82014: 152015: 172016: 82017: 132018: 162019: 102020: 182021: 132022: 162023: 192024: 302025: 212026: 25
2009high 30 (2024) · low 2 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 242 · See all
  • K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2010 · cites it directly184descendants
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011 · cites it directly156descendants
  • K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · cites it directly102descendants
  • K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc. · 2011 · 2 generations on98descendants
  • K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc. · 2013 · 3 generations on97descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−8K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−7K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−6K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−5K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−4K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−3K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−2K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−1K042508Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc.2004—
0 (this device)K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008—
+1K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc.2010—
+1K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011—
+1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.2011—
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199940
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201020
201120
201270
201380
2014150
2015170
201680
2017130
2018160
2019100
2020180
2021131
2022160
2023190
2024300
2025210
2026250
FIG. 1 — Lineage of K080828, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

1 device in this family has a Class I recall. 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? (7)

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
*K041203Summit Oct Spinal System
Summary page 1
…RODUCT CODE: KWP, MNI, MNH PROPRIETARY NAME: MOUNTAINEER OCT Spinal System PREDICATE DEVICES: MOUNTAINEER OCT Spinal System (K041203, K042508) SUMMIT OCT Spinal System (K002733, K010681,…
Depuy Spine, Inc.2004—
*K042508Sumit Oct Spinal System and Mountaineer Oct Spinal System
Summary page 1
…MNH PROPRIETARY NAME: MOUNTAINEER OCT Spinal System PREDICATE DEVICES: MOUNTAINEER OCT Spinal System (K041203, K042508) SUMMIT OCT Spinal System (K002733, K010681, K013222, K022190, K03…
Depuy Spine, Inc.2004—
*K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal System
Summary page 1
…PREDICATE DEVICES: MOUNTAINEER OCT Spinal System (K041203, K042508) SUMMIT OCT Spinal System (K002733, K010681, K013222, K022190, K030103) DEVICE DESCRIPTION: Expansion of the size offerin…
Depuyacromed2000—
*K010681Summit Occipito-Cervico-Thoracic (Oct) Spinal System
Summary page 1
…E DEVICES: MOUNTAINEER OCT Spinal System (K041203, K042508) SUMMIT OCT Spinal System (K002733, K010681, K013222, K022190, K030103) DEVICE DESCRIPTION: Expansion of the size offering of MOUN…
Depuyacromed2001—
*K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal System
Summary page 1
…pinal System (K041203, K042508) SUMMIT OCT Spinal System (K002733, K010681, K013222, K022190, K030103) DEVICE DESCRIPTION: Expansion of the size offering of MOUNTAINEER OCT…
Depuyacromed2001—
*K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System
Summary page 1
…tem (K041203, K042508) SUMMIT OCT Spinal System (K002733, K010681, K013222, K022190, K030103) DEVICE DESCRIPTION: Expansion of the size offering of MOUNTAINEER OCT Spinal…
Depuyacromed2002—
*K030103Summit Oct Spinal System Minipolyaxial Screws
Summary page 1
…203, K042508) SUMMIT OCT Spinal System (K002733, K010681, K013222, K022190, K030103) DEVICE DESCRIPTION: Expansion of the size offering of MOUNTAINEER OCT Spinal System M…
Depuyacromed2003—

Also cleared against K041203: 11 other devices →

What descends from it? (242)

See all 242

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

NumberDeviceApplicantDecidedDescendants
K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc.2010184
K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011156
K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102
K083863Theken Atoll Oct Spinal SystemTheken Spine, LLC200921
K093319Nuvasive Vuepoint Oct SystemNuvasive, Inc.201010
K132332Mountaineer Oct Spinal SystemMedos International SARL20134
K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180
K091359Gso PCT Spinal SystemGold Standard Orthopaedics, LLC20090

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
  • None of the 15 ancestors has a recall.
  • Of its descendants, K103100 (Depuy Spine, Inc., 2010) has gone furthest, with 184 descendants of its own.
  • 11 other devices also cite its predicate K041203.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows: When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for: ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history…

Read the full statement (186 words)

The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows:

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:

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

spondylolisthesis

spinal stenosis

fracture/dislocation

atlanto/axial fracture with instability

occipitocervical dislocation

revision of previous cervical spine surgery

tumors

The occipital bone screws are limited to occipital fixation only.

The use of the minipolyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.

The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX TM, MONARCHTm, EXPEDIUMTM and MOSS® MIAMI Tm Systems using the dual wedding band and axial connectors, and via dual diameter rods.

Indications for use as stated in the FDA summary.

Also cleared against K041203

11 other devices cite the same predicate.

  • K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
  • K132332Mountaineer Oct Spinal SystemMedos International SARL · 2013
  • K121979Pass Oct Spinal SystemMedicrea International · 2013
  • K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital PlatesExactech, Inc. · 2013
  • K103100Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2010
  • K072568Modification to Oasys SystemStryker Spine · 2007

More from Depuy Spine, Inc.

86 FDA decisions under this applicant name. See the company

  • K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc. · 2020
  • K142185Expedium Verse Spine SystemDepuy Spine, Inc. · 2014
  • K111136Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 20121 recall
  • K121020Viper SystemDepuy Spine, Inc. · 2012
  • K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2011

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K080828 · printed Nov 5, 2026

Cite this page

510(k) Report. “K080828: Mountaineer Oct Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080828

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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