510(k) Report

510(k) · Cleared

Cleared

Pioneer Silicoat Sternal Cable

K993286510(k) SpecialCleared Nov 23, 199953-day reviewClass II21 CFR 888.3010

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

Pioneer Surgical Technology · JDQ Cerclage, Fixation

Cleared on Nov 23, 1999 as substantially equivalent to K922952 (Pioneer Surgical Technology, 1993) and 2 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1993. 64 later devices descend from it.

Decided
Nov 23, 1999
Review
53 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K922952 (1993). 3 ancestors in all. 64 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 2 other ancestors2006: 1 descendant cleared2014: 4 descendants cleared2011: 1 descendant cleared2007: 1 descendant cleared2012: 1 descendant cleared2024: 12 descendants cleared2013: 1 descendant cleared2016: 2 descendants cleared2021: 3 descendants cleared2025: 14 descendants cleared2023: 8 descendants cleared2015: 2 descendants cleared2022: 3 descendants cleared2026: 11 descendants clearedK922952 · Songer Cable System · Pioneer Surgical Technology · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 7 descendants6 generations forward: 8 descendants7 generations forward: 13 descendants8 generations forward: 16 descendants9 generations forward: 2 descendants K922952 · Songer Cable System · Pioneer Surgical Technology · 19930+5
  1. Root · 1 generation backK922952 Songer Cable SystemPioneer Surgical Technology · 1993
  2. This deviceK993286 Pioneer Silicoat Sternal CablePioneer Surgical Technology · 1999
  3. Descendant · cites it directly · 62 of its ownK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
  4. Descendant · 2 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
  5. Descendant · 3 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
  6. Descendant · 4 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
  7. Descendant · 5 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12011: 12012: 12013: 12014: 42015: 22016: 22021: 32022: 32023: 82024: 122025: 142026: 11
2006high 14 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 64 · See all
  • K051165KLS Martin Sternal TalonKLS-Martin L.P. · 2006 · cites it directly62descendants
  • K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 2 generations on61descendants
  • K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 3 generations on45descendants
  • K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 4 generations on39descendants
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 5 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922952Songer Cable SystemPioneer Surgical Technology1993—
0 (this device)K993286Pioneer Silicoat Sternal CablePioneer Surgical Technology1999—
+1K051165KLS Martin Sternal TalonKLS-Martin L.P.2006—
+2K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.2007—
+3K151983KLS Martin LSS Plating SystemKLS Martin L.P.2016—
+4K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
201110
201210
201310
201440
201520
201620
202130
202230
202380
2024120
2025140
2026110
FIG. 1 — Lineage of K993286, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 JDQ? 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 JDQ device

  1. #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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? (3)

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
*K922952Songer Cable System
Summary page 1
…99 Pioneer SilCoat Sternal Cable Cerclage, Bone Fixation Cerclage, Bone Fixation Regulation Number: CFR 888.3010 Classification Number: 87JDQ Il SONGER™ Cable System: K922952; K935481; and K941213 The Pioneer SilCoat Sternal Cable System consists of cables and associated crimps. Each cable; has a centr…
Pioneer Surgical Technology1993—
*K935481Sponger Cable System, Modification
Summary page 1
…er SilCoat Sternal Cable Cerclage, Bone Fixation Cerclage, Bone Fixation Regulation Number: CFR 888.3010 Classification Number: 87JDQ Il SONGER™ Cable System: K922952; K935481; and K941213 The Pioneer SilCoat Sternal Cable System consists of cables and associated crimps. Each cable; has a central portio…
Pioneer Surgical Technology1994—
*K941213Songer Cable System
Summary page 1
…ernal Cable Cerclage, Bone Fixation Cerclage, Bone Fixation Regulation Number: CFR 888.3010 Classification Number: 87JDQ Il SONGER™ Cable System: K922952; K935481; and K941213 The Pioneer SilCoat Sternal Cable System consists of cables and associated crimps. Each cable; has a central portion coated with…
Pioneer Surgical Technology1994—

Also cleared against K922952: 6 other devices →

What descends from it? (64)

See all 64

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

NumberDeviceApplicantDecidedDescendants
K051165KLS Martin Sternal TalonKLS-Martin L.P.200662
K101484Compressyn BandDallen Medical20115
K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K051165 (KLS-Martin L.P., 2006) has gone furthest, with 62 descendants of its own.
  • 6 other devices also cite its predicate K922952.

How does its category compare?

All JDQ devices

JDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDQ

2in 2025

2007: 12008: 22009: 22011: 62012: 32013: 12014: 22015: 52016: 42017: 12018: 62020: 42022: 22023: 32024: 32025: 22026 (partial year): 1
2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDQ

130in 2024

2011: 130 days median2012: 134 days median2015: 92 days median2016: 129 days median2018: 101 days median2020: 93 days median2023: 141 days median2024: 130 days median
2007high 141 (2023) · low 92 (2015)2026

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

Recalls per year · JDQ

5in 2019

2008: 22010: 22013: 12015: 12019: 5
2007high 5 (2019) · low 0 (2007)2026

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

Adverse event reports per year · JDQ

84in 2025

2007: 52008: 252009: 192010: 282011: 302012: 1302013: 3212014: 2232015: 2052016: 2242017: 1382018: 1822019: 1582020: 1252021: 1412022: 1342023: 982024: 1152025: 84
2007high 321 (2013) · low 5 (2007)2025

MAUDE reports naming product code JDQ, 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
20071—05
20082—225
20092—019
20100—228
20116130030
201231340130
20131—1321
20142—0223
20155921205
201641290224
20171—0138
201861010182
20190—5158
20204930125
20210—0141
20222—0134
20233141098
202431300115
20252—084
20261—0—

What is it indicated for?

The Pioneer SilCoat Sternal Cable is indicated for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the stemum to promote fusion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K922952

6 other devices cite the same predicate.

  • K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System…Medos International SARL · 2019
  • K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas · 2018
  • K172206NAJA™ Ligament Correction SystemCousin Biotech Sas · 2018
  • K153348Jazz LockImplanet, S.A. · 2016
  • K133482Silc Fixation SystemGlobus Medical, Inc. · 2014
  • K071271Biomet Cable SystemBiomet Manufacturing, Inc. · 2007

More from Pioneer Surgical Technology

50 FDA decisions under this applicant name. See the company

  • K110561Fortross Bone Void FillerPioneer Surgical Technology · 2011
  • K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology · 2011
  • 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 JDQ

The JDQ category page

  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
  • K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
  • K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc. · 2025
  • K232733Mbrace CableMedacta International S.A. · 2024
  • K233949ACCORD Cable SystemSmith & Nephew, Inc. · 2024

https://510kreport.com/device/K993286 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993286: Pioneer Silicoat Sternal Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993286

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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