510(k) Report

510(k) · Cleared

Cleared

Sponger Cable System, Modification

K935481510(k) TraditionalCleared Jan 26, 1994125-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 Jan 26, 1994 after a 125-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 81 later devices descend from it.

Decided
Jan 26, 1994
Review
125 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
0

81 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2018: 3 descendants cleared2012: 3 descendants cleared2015: 5 descendants cleared1999: 1 descendant cleared2016: 5 descendants cleared2014: 5 descendants cleared2026: 12 descendants cleared2017: 1 descendant cleared2020: 2 descendants cleared2006: 1 descendant cleared2011: 1 descendant cleared2007: 1 descendant cleared2024: 12 descendants cleared2013: 1 descendant cleared2021: 3 descendants cleared2023: 8 descendants cleared2022: 3 descendants cleared2025: 14 descendants cleared1990200020102020
  1. This deviceK935481 Sponger Cable System, ModificationPioneer Surgical Technology · 1994
  2. Descendant · cites it directly · 64 of its ownK993286 Pioneer Silicoat Sternal CablePioneer Surgical Technology · 1999
  3. Descendant · 2 generations on · 62 of its ownK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
  4. Descendant · 3 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
  5. Descendant · cites it directly · 46 of its ownK122293 Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
  6. Descendant · 4 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

1999: 12006: 12007: 12011: 12012: 32013: 12014: 52015: 52016: 52017: 12018: 32020: 22021: 32022: 32023: 82024: 122025: 142026: 12
1999high 14 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 81 · See all
  • K993286Pioneer Silicoat Sternal CablePioneer Surgical Technology · 1999 · cites it directly64descendants
  • K051165KLS Martin Sternal TalonKLS-Martin L.P. · 2006 · 2 generations on62descendants
  • K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 3 generations on61descendants
  • K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012 · cites it directly46descendants
  • K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 4 generations on45descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935481Sponger Cable System, ModificationPioneer Surgical Technology1994—
+1K993286Pioneer Silicoat Sternal CablePioneer Surgical Technology1999—
+2K051165KLS Martin Sternal TalonKLS-Martin L.P.2006—
+3K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.2007—
+1K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2012—
+4K151983KLS Martin LSS Plating SystemKLS Martin L.P.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200610
200710
201110
201230
201310
201450
201550
201650
201710
201830
202020
202130
202230
202380
2024120
2025140
2026120
FIG. 1 — Lineage of K935481, 1994–2026Source: 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 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
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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? (81)

See all 81

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

NumberDeviceApplicantDecidedDescendants
K993286Pioneer Silicoat Sternal CablePioneer Surgical Technology199964
K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246
K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544
K151907Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage…Zimmer, Inc.20152
K180582Sternal Cable SystemA & E Medical Corporation20181
K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161
K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.20151
K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.20160
K120016Pioneer Sternal Assist Implant SystemPioneer Surgical Technology, Inc.20120

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, K993286 (Pioneer Surgical Technology, 1999) has gone furthest, with 64 descendants of its own.

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—

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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/K935481 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935481: Sponger Cable System, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935481

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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