510(k) Report

510(k) · Cleared

Cleared

Pioneer Laboratories Bone Plate with Cerclage Cables

K940729510(k) TraditionalCleared Dec 21, 1994306-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 Dec 21, 1994 after a 306-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Dec 21, 1994
Review
306 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2016: 2 descendants cleared2015: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK940729 Pioneer Laboratories Bone Plate with Cerclage CablesPioneer Surgical Technology · 1994
  2. Descendant · cites it directly · 1 of its ownK151716 Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemZimmer, Inc. · 2016
  3. Descendant · cites it directly · 1 of its ownK151888 Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2015
  4. Descendant · 2 generations on · 0 of its ownK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
  5. Descendant · cites it directly · 0 of its ownK153242 Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2016

Most influential descendants

Showing 4 of 4 · See all
  • K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemZimmer, Inc. · 2016 · cites it directly1descendant
  • K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2015 · cites it directly1descendant
  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026 · 2 generations on0descendants
  • K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940729Pioneer Laboratories Bone Plate with Cerclage CablesPioneer Surgical Technology1994—
+1K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemZimmer, Inc.2016—
+1K151888Frontier Medical Devices In-line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.2015—
+2K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.2026—
+1K153242Frontier Medical Devices In-Line Orthopedic Cable Cerclage SystemFrontier Medical Devices, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201620
202610
FIG. 1 — Lineage of K940729, 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate 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

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, K151716 (Zimmer, Inc., 2016) has gone furthest, with 1 descendant 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—
Cite this page

510(k) Report. “K940729: Pioneer Laboratories Bone Plate with Cerclage Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K940729

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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