510(k) Report

510(k) · Cleared

Cleared

Synergy 4.0 MM, 4.5 MM VLS Screws

K011437510(k) SpecialCleared Jun 6, 200127-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 Jun 6, 2001 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 325 later devices descend from it.

Decided
Jun 6, 2001
Review
27 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2023: 36 descendants cleared2009: 2 descendants cleared2008: 1 descendant cleared2015: 22 descendants cleared2011: 5 descendants cleared2014: 17 descendants cleared2020: 19 descendants cleared2013: 17 descendants cleared2019: 18 descendants cleared2012: 5 descendants cleared2010: 3 descendants cleared2017: 20 descendants cleared2021: 18 descendants cleared2016: 16 descendants cleared2025: 30 descendants cleared2026: 24 descendants cleared2024: 28 descendants cleared2018: 22 descendants cleared2022: 22 descendants cleared200020052010201520202025
  1. This deviceK011437 Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl. · 2001
  2. Descendant · cites it directly · 154 of its ownK090203 5.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P. · 2009
  3. Descendant · 2 generations on · 153 of its ownK100220 Polaris Spinal SystemEbi, L.P. · 2010
  4. Descendant · cites it directly · 138 of its ownK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
  5. Descendant · 2 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
  6. Descendant · cites it directly · 104 of its ownK103393 Polaris Spinal SystemBiomet Spine · 2011

Showing 5 of 325 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22010: 32011: 52012: 52013: 172014: 172015: 222016: 162017: 202018: 222019: 182020: 192021: 182022: 222023: 362024: 282025: 302026: 24
2008high 36 (2023) · low 1 (2008)2026

Most influential descendants

Showing 5 of 325 · See all
  • K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P. · 2009 · cites it directly154descendants
  • K100220Polaris Spinal SystemEbi, L.P. · 2010 · 2 generations on153descendants
  • K120291OP Spine SystemOrthoPediatrics Corp. · 2012 · cites it directly138descendants
  • K121630Range Spinal SystemK2m, Inc. · 2012 · 2 generations on127descendants
  • K103393Polaris Spinal SystemBiomet Spine · 2011 · cites it directly104descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011437Synergy 4.0 MM, 4.5 MM VLS ScrewsInterpore Cross Intl.2001—
+1K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P.2009—
+2K100220Polaris Spinal SystemEbi, L.P.2010—
+1K120291OP Spine SystemOrthoPediatrics Corp.2012—
+2K121630Range Spinal SystemK2m, Inc.2012—
+1K103393Polaris Spinal SystemBiomet Spine2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201030
201150
201250
2013170
2014170
2015220
2016160
2017200
2018220
2019180
2020190
2021180
2022220
2023360
2024280
2025300
2026240
FIG. 1 — Lineage of K011437, 2001–2026Source: 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? (325)

See all 325

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

NumberDeviceApplicantDecidedDescendants
K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P.2009154
K120291OP Spine SystemOrthoPediatrics Corp.2012138
K103393Polaris Spinal SystemBiomet Spine2011104
K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382
K081165Ellipse Lumbar Posterior Osteosynthesis SystemSpineart200819
K132101Anax 5.5 Spinal SystemU&I Corporation201313
K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910
K151921Sterispine PSSafe Orthopaedics20153
K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142
K231737ANAX™ 5.5 Spinal SystemInnosys Co., Ltd.20231

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, K090203 (Ebi, L.P., 2009) has gone furthest, with 154 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—

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Recent decisions in MNI

The MNI category page

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  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
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https://510kreport.com/device/K011437 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011437: Synergy 4.0 MM, 4.5 MM VLS Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011437

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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