510(k) Report

510(k) · Cleared

Cleared

Capless Pedicle Screw System

K052847510(k) TraditionalCleared Dec 12, 200566-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

X-Spine Systems, Inc. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Dec 12, 2005 after a 66-day review. The FDA summary names no predicate by number. 21 later devices descend from it.

Decided
Dec 12, 2005
Review
66 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

21 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared2010: 2 descendants cleared2012: 3 descendants cleared2016: 2 descendants cleared2013: 2 descendants cleared2022: 1 descendant cleared2015: 2 descendants cleared2011: 1 descendant cleared2018: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK052847 Capless Pedicle Screw SystemX-Spine Systems, Inc. · 2005
  2. Descendant · cites it directly · 8 of its ownK081978 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009
  3. Descendant · cites it directly · 7 of its ownK101112 Reliance Spinal Screw SystemReliance Medical Systems · 2010
  4. Descendant · cites it directly · 7 of its ownK090224 Fortex Pedicle Screw SystemX-Spine Systems, Inc. · 2009
  5. Descendant · 2 generations on · 5 of its ownK123521 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
  6. Descendant · 2 generations on · 5 of its ownK110896 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2009: 32010: 22011: 12012: 32013: 22015: 22016: 22018: 22020: 12021: 12022: 12023: 1
2009high 3 (2009) · low 0 (2014)2026

Most influential descendants

Showing 5 of 21 · See all
  • K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009 · cites it directly8descendants
  • K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010 · cites it directly7descendants
  • K090224Fortex Pedicle Screw SystemX-Spine Systems, Inc. · 2009 · cites it directly7descendants
  • K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013 · 2 generations on5descendants
  • K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052847Capless Pedicle Screw SystemX-Spine Systems, Inc.2005—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC2009—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems2010—
+1K090224Fortex Pedicle Screw SystemX-Spine Systems, Inc.2009—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC2013—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200930
201020
201110
201230
201320
201520
201620
201820
202010
202110
202210
202310
FIG. 1 — Lineage of K052847, 2005–2023Source: 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 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098
K101112Reliance Spinal Screw SystemReliance Medical Systems20107
K090224Fortex Pedicle Screw SystemX-Spine Systems, Inc.20097
K083743Capsure PS SystemSpine Wave, Inc.20093

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, K081978 (Reliance Medical Systems, LLC, 2009) has gone furthest, with 8 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—

What is it indicated for?

The Capless Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Capless Pedicle Screw System is intended to provide immobilization and stabilization of spinal…

Read the full statement (119 words)

The Capless Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Capless Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Indications for use as stated in the FDA summary.

More from X-Spine Systems, Inc.

34 FDA decisions under this applicant name. See the company

  • K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 20181 recall
  • K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
  • K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 20171 recall
  • K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 20171 recall
  • K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017

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/K052847 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052847: Capless Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052847

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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