510(k) Report

510(k) · Cleared

Cleared

Synergy VLS Cap Nut Models 2206, 6102

K000236510(k) SpecialCleared Feb 16, 200020-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

Interpore Cross Intl. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Feb 16, 2000 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 79 later devices descend from it.

Decided
Feb 16, 2000
Review
20 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

79 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2017: 6 descendants cleared2018: 3 descendants cleared2014: 2 descendants cleared2016: 5 descendants cleared2015: 3 descendants cleared2019: 5 descendants cleared2013: 2 descendants cleared2010: 1 descendant cleared2020: 8 descendants cleared2021: 1 descendant cleared2024: 6 descendants cleared2025: 12 descendants cleared2023: 13 descendants cleared2022: 5 descendants cleared2026: 6 descendants cleared200020052010201520202025
  1. This deviceK000236 Synergy VLS Cap Nut Models 2206, 6102Interpore Cross Intl. · 2000
  2. Descendant · cites it directly · 41 of its ownK120696 Tiger Spine SystemCorelink, LLC · 2012
  3. Descendant · 2 generations on · 40 of its ownK131250 Tiger Spine SystemCorelink, LLC · 2013
  4. Descendant · 2 generations on · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
  5. Descendant · 3 generations on · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
  6. Descendant · 4 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 22014: 22015: 32016: 52017: 62018: 32019: 52020: 82021: 12022: 52023: 132024: 62025: 122026: 6
2010high 13 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 79 · See all
  • K120696Tiger Spine SystemCorelink, LLC · 2012 · cites it directly41descendants
  • K131250Tiger Spine SystemCorelink, LLC · 2013 · 2 generations on40descendants
  • K133369Tiger Spine SystemCorelink, LLC · 2014 · 2 generations on29descendants
  • K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016 · 3 generations on17descendants
  • K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000236Synergy VLS Cap Nut Models 2206, 6102Interpore Cross Intl.2000—
+1K120696Tiger Spine SystemCorelink, LLC2012—
+2K131250Tiger Spine SystemCorelink, LLC2013—
+2K133369Tiger Spine SystemCorelink, LLC2014—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC2016—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201320
201420
201530
201650
201760
201830
201950
202080
202110
202250
2023130
202460
2025120
202660
FIG. 1 — Lineage of K000236, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MNI? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (79)

See all 79

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

NumberDeviceApplicantDecidedDescendants
K120696Tiger Spine SystemCorelink, LLC201241
K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910
K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC20108
K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164
K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183
K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172
K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162
K153404Zavation Spinal SystemZavation, LLC20161
K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141
K163011PHA S1 Spinal SystemPhamedica, Inc.20170

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, K120696 (Corelink, LLC, 2012) has gone furthest, with 41 descendants of its own.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

More from Interpore Cross Intl.

39 FDA decisions under this applicant name. See the company

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  • K041407Titanium Mesh ImplantInterpore Cross Intl. · 2004
  • K043229Modification to Altius Oct SystemInterpore Cross Intl. · 2004
  • K042798C-Tek C-Trun Anterior Cervical Plate SystemInterpore Cross Intl. · 2004

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K000236 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000236: Synergy VLS Cap Nut Models 2206, 6102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000236

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026