510(k) Report

510(k) · Cleared

Cleared

Posterior Cable Screw

K022908510(k) TraditionalCleared Jan 22, 2004506-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

Pioneer Surgical Technology · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Jan 22, 2004 as substantially equivalent to K003351 (Spinal Concepts, Inc., 2001) after a 506-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided
Jan 22, 2004
Review
506 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003351 (2001). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant clearedK003351 · Parsfix Cable-Screw System · Spinal Concepts, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K003351 · Parsfix Cable-Screw System · Spinal Concepts, Inc. · 20010
  1. Root · 1 generation backK003351 Parsfix Cable-Screw SystemSpinal Concepts, Inc. · 2001
  2. This deviceK022908 Posterior Cable ScrewPioneer Surgical Technology · 2004
  3. Descendant · cites it directly · 0 of its ownK151346 Frontier Medical Devices Posterior Cable Screw SystemFrontier Medical Devices, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K151346Frontier Medical Devices Posterior Cable Screw SystemFrontier Medical Devices, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003351Parsfix Cable-Screw SystemSpinal Concepts, Inc.2001—
0 (this device)K022908Posterior Cable ScrewPioneer Surgical Technology2004—
+1K151346Frontier Medical Devices Posterior Cable Screw SystemFrontier Medical Devices, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K022908, 2001–2015Source: 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
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What was it cleared against? (1)

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
*K003351Parsfix Cable-Screw System
Summary page 1
…Regulations, Title 21. The product codes are MNI and JDQ, respectively. PREDICATE DEVICE: The ParsFix Cable-Screw System (K003351 - SE 01/24/01, Spinal Concepts, Inc. - Austin, TX) DEVICE Proprietary Name: Pioneer Poste…
Spinal Concepts, Inc.2001—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K151346Frontier Medical Devices Posterior Cable Screw SystemFrontier Medical Devices, Inc.20150

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?

  • Its one ancestor has no recall.
  • Of its descendants, K151346 (Frontier Medical Devices, Inc., 2015) has gone furthest, with 0 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 Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolisthesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following: * Defect…

Read the full statement (113 words)

The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolisthesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:

* Defect of the pars interarticularis

* Spondylolithesis

The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.

Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.

Indications for use as stated in the FDA summary.

More from Pioneer Surgical Technology

50 FDA decisions under this applicant name. See the company

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  • K101525Pioneer Spinous Process Fusion PlatePioneer Surgical Technology · 2010
  • K093692Quantum/ Streamline Spinal System Model 02-Series and 10-SeriesPioneer Surgical Technology · 2010
  • K093771Quantum/Streamline TL Mis Spinal SystemPioneer Surgical Technology · 2010

Recent decisions in MNI

The MNI category page

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  • 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/K022908 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022908: Posterior Cable Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022908

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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