510(k) Report

510(k) · Cleared

Cleared

Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates

K121877510(k) TraditionalCleared Feb 12, 2013229-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

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

Cleared on Feb 12, 2013 as substantially equivalent to K110353 (Depuy Spine, Inc., 2011) and 7 other predicates after a 229-day review. Its family tree reaches back 13 generations to 2001. 4 later devices descend from it.

Decided
Feb 12, 2013
Review
229 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
8

Its longest line of descent runs back 13 generations to K003155 (2001). 95 ancestors in all, the oldest K841189 (1984). 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2009: 4 other ancestors2004: 19 other ancestors2008: 4 other ancestors2007: 2 other ancestors2006: 4 other ancestors2005: 10 other ancestors2003: 6 other ancestors2002: 8 other ancestors2001: 7 other ancestors2000: 7 other ancestors1999: 5 other ancestors1998: 2 other ancestors1997: 1 other ancestor1985: 1 other ancestor1984: 1 other ancestor2014: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004×3: 3 generations cleared close together, K060719 (2006), K061938 (2006), K062427 (2006) K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 19 other ancestors3 generations back: 18 other ancestors4 generations back: 4 other ancestors5 generations back: 4 other ancestors6 generations back: 11 other ancestors7 generations back: 18 other ancestors8 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K062427 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K061938 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−10−50
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 9 generations between
  3. 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  4. 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  5. 1 generation backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  6. This deviceK121877 Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System…Exactech, Inc. · 2013
  7. Descendant · cites it directly · 3 of its ownK133374 Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014
  8. Descendant · 2 generations on · 2 of its ownK150254 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · Recalled
  9. Descendant · 3 generations on · 1 of its ownK161498 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2016
  10. Descendant · 4 generations on · 0 of its ownK172139 Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2017
Show all 13 generations
  1. Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 12 generations backK012254 VBROsteotech, Inc. · 2001
  3. 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 9 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 8 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 7 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 6 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 5 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 4 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 3 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 2 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 1 generation backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. This deviceK121877 Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System…Exactech, Inc. · 2013

Most influential descendants

Showing 4 of 4 · See all
  • K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014 · cites it directly3descendants
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2015 · 2 generations on2descendants
  • K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2016 · 3 generations on1descendant
  • K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2017 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−12K012254VBROsteotech, Inc.2001—
−11K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−10K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−9K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−8K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−7K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−6K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−5K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−4K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−3K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−1K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
0 (this device)K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System…Exactech, Inc.2013—
+1K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I2014—
+2K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20153
+3K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2016—
+4K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199710
199820
199950
200070
200170
200280
200360
2004190
2005100
200640
200720
200840
200940
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201610
201710
FIG. 1 — Lineage of K121877, 2001–2017Source: 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? (8)

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
*K110353Mountaineer Oct Spinal SystemDepuy Spine, Inc.2011—
*K042508Sumit Oct Spinal System and Mountaineer Oct Spinal System
Summary page 1
…nterlaminal Product Code: KWP Legally Marketed Devices to Which Substantial Equivalence Is Claimed * DePuy Mountaineer OCT Spinal System (KI 10353, K042508, and K04 1203) a Medtronic Vertex Select Reconstruction System (KI 10522, K091365, K090714, and K082728) a Zimmer (A…
Depuy Spine, Inc.2004—
*K041203Summit Oct Spinal System
Summary page 1
…Product Code: KWP Legally Marketed Devices to Which Substantial Equivalence Is Claimed * DePuy Mountaineer OCT Spinal System (KI 10353, K042508, and K04 1203) a Medtronic Vertex Select Reconstruction System (KI 10522, K091365, K090714, and K082728) a Zimmer (Abbott Spine) N…
Depuy Spine, Inc.2004—
*K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
*K091365Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 1
…bstantial Equivalence Is Claimed * DePuy Mountaineer OCT Spinal System (KI 10353, K042508, and K04 1203) a Medtronic Vertex Select Reconstruction System (KI 10522, K091365, K090714, and K082728) a Zimmer (Abbott Spine) Nex-Link OCT Cervical Plating System (K090060) IDevice Description The…
Medtronic Soafamor Danek2009—
*K090714Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 1
…Equivalence Is Claimed * DePuy Mountaineer OCT Spinal System (KI 10353, K042508, and K04 1203) a Medtronic Vertex Select Reconstruction System (KI 10522, K091365, K090714, and K082728) a Zimmer (Abbott Spine) Nex-Link OCT Cervical Plating System (K090060) IDevice Description The Gibralt O…
Medtronic Sofamor Danek2009—
*K082728Vertex Recontruction System, Vertex Select Reconstruction System
Summary page 1
…med * DePuy Mountaineer OCT Spinal System (KI 10353, K042508, and K04 1203) a Medtronic Vertex Select Reconstruction System (KI 10522, K091365, K090714, and K082728) a Zimmer (Abbott Spine) Nex-Link OCT Cervical Plating System (K090060) IDevice Description The Gibralt Occipital Spine Syste…
Medtronic Sofamor Danek USA, Inc.2009—
*K090060Nexlink Oct System, Model 7000 Series
Summary page 1
…203) a Medtronic Vertex Select Reconstruction System (KI 10522, K091365, K090714, and K082728) a Zimmer (Abbott Spine) Nex-Link OCT Cervical Plating System (K090060) IDevice Description The Gibralt Occipital Spine Systemn is a new posterior system intended to help provide immobilization and s…
Abbott Spine, Inc.2009—

Also cleared against K110353: 12 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143

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 12 years and passes through 5 companies; a new generation was cleared every 9 months on median.
  • 6 of the 95 ancestors have a recall of any class.
  • Of its descendants, K133374 (Pioneer Surgical Technology, Inc. (Rti Surgical, I, 2014) has gone furthest, with 3 descendants of its own.
  • 12 other devices also cite its predicate K110353.

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. 2013, 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?

When used with the Gibralt Spine System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3). The Gibralt Occipital Spine System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation…

Read the full statement (107 words)

When used with the Gibralt Spine System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3). The Gibralt Occipital Spine System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation, atlarito-axial fracture with instability, failed previous fusion and/or tumors.

The Occipital Bone Screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in T1I-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.

Indications for use as stated in the FDA summary.

Also cleared against K110353

12 other devices cite the same predicate.

  • K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart · 2020
  • K182837M.U.S.T. Mini ExtensionMedacta International S.A. · 2019
  • K182182YUKON OCT Spinal SystemK2m · 2018
  • K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
  • K171444YUKON OCT Spinal SystemK2m, Inc. · 20173 recalls
  • K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I · 2014

More from Exactech, Inc.

207 FDA decisions under this applicant name. See the company

  • K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025
  • K243275Equinoxe® Scapula Fracture SystemExactech, Inc. · 2025
  • K243839Alteon® HA Femoral StemsExactech, Inc. · 2025

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/K121877 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121877: Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod, Gibralt Occipital Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121877

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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