510(k) Report

510(k) · Cleared

Cleared

Life Spine Lumbar Plate System

K093200510(k) TraditionalCleared Jan 19, 2010102-day reviewClass II21 CFR 888.3060

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

Life Spine · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 19, 2010 after a 102-day review. The FDA summary names no predicate by number. 13 later devices descend from it.

Decided
Jan 19, 2010
Review
102 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
0

13 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2018: 1 descendant cleared2026: 2 descendants cleared2017: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared2020: 2 descendants cleared2021: 1 descendant cleared2025: 1 descendant cleared2010201520202025
  1. This deviceK093200 Life Spine Lumbar Plate SystemLife Spine · 2010
  2. Descendant · cites it directly · 12 of its ownK132589 Anterior Lumbar Plate System (Presidio)Life Spine, Inc. · 2013
  3. Descendant · 2 generations on · 10 of its ownK172131 2 Hole Lateral Plating SystemLife Spine, Inc. · 2017
  4. Descendant · 2 generations on · 9 of its ownK180166 Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018
  5. Descendant · 3 generations on · 5 of its ownK200338 ProLift Lateral FixatedLife Spine, Inc. · 2020
  6. Descendant · 4 generations on · 3 of its ownK210061 ProLift Lateral HELO FixatedLife Spine, Inc. · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013: 12017: 12018: 12020: 22021: 12022: 22023: 22025: 12026: 2
2013high 2 (2020) · low 0 (2014)2026

Most influential descendants

Showing 5 of 13 · See all
  • K132589Anterior Lumbar Plate System (Presidio)Life Spine, Inc. · 2013 · cites it directly12descendants
  • K1721312 Hole Lateral Plating SystemLife Spine, Inc. · 2017 · 2 generations on10descendants
  • K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc. · 2018 · 2 generations on9descendants
  • K200338ProLift Lateral FixatedLife Spine, Inc. · 2020 · 3 generations on5descendants
  • K210061ProLift Lateral HELO FixatedLife Spine, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K093200Life Spine Lumbar Plate SystemLife Spine2010—
+1K132589Anterior Lumbar Plate System (Presidio)Life Spine, Inc.2013—
+2K1721312 Hole Lateral Plating SystemLife Spine, Inc.2017—
+2K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.2018—
+3K200338ProLift Lateral FixatedLife Spine, Inc.2020—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201710
201810
202020
202110
202220
202320
202510
202620
FIG. 1 — Lineage of K093200, 2010–2026Source: 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), 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 KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K132589Anterior Lumbar Plate System (Presidio)Life Spine, Inc.201312

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, K132589 (Life Spine, Inc., 2013) has gone furthest, with 12 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LI-SI) spine instability as a result of fracture (including dislocation and…

Read the full statement (108 words)

The Life Spine Anterior Lumbar Fixation System (Presidio) is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (TI-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LI-SI) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Indications for use as stated in the FDA summary.

More from Life Spine

36 FDA decisions under this applicant name. See the company

  • K182470Plateau Spacer SystemLife Spine · 2018
  • K160169The Life Spine Subtalar Implant SystemLife Spine · 2016
  • K150368Tarsa-Link Wedge Fixation SystemLife Spine · 2015
  • K141905Pro-Link Wedge SystemLife Spine · 2014
  • K133717Longbow Spacer SystemLife Spine · 2014

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https://510kreport.com/device/K093200 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093200: Life Spine Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093200

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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