510(k) Report

510(k) · Cleared

Cleared

Pioneer Surgical Technology Extended GTR, Model 501-601

K000734510(k) TraditionalCleared May 5, 200059-day reviewClass II21 CFR 888.3030

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

Pioneer Surgical Technology · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on May 5, 2000 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided
May 5, 2000
Review
59 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2026: 2 descendants cleared2021: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK000734 Pioneer Surgical Technology Extended GTR, Model 501-601Pioneer Surgical Technology · 2000
  2. Descendant · cites it directly · 6 of its ownK120772 NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button…Zimmer GmbH · 2012 · Recalled
  3. Descendant · cites it directly · 2 of its ownK151907 Cable-Ready® Cable Grip System: Cable-Ready® GTR System…Zimmer, Inc. · 2015 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
  5. Descendant · cites it directly · 1 of its ownK072250 Supercable Grip and Plate SystemKinamed, Inc. · 2007 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2007: 12012: 12015: 12017: 12021: 22023: 12024: 12026: 2
2007high 2 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 10 · See all
  • K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH · 2012 · cites it directly6descendants
  • K151907Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage…Zimmer, Inc. · 2015 · cites it directly2descendants
  • K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021 · 2 generations on1descendant
  • K072250Supercable Grip and Plate SystemKinamed, Inc. · 2007 · cites it directly1descendant
  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000734Pioneer Surgical Technology Extended GTR, Model 501-601Pioneer Surgical Technology2000—
+1K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB…Zimmer GmbH20122
+1K151907Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm…Zimmer, Inc.20151
+2K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021—
+1K072250Supercable Grip and Plate SystemKinamed, Inc.20071
+2K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201210
201510
201710
202120
202310
202410
202620
FIG. 1 — Lineage of K000734, 2000–2026Source: 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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
  2. #2 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? (10)

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

NumberDeviceApplicantDecidedDescendants
K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH20126
K151907Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage…Zimmer, Inc.20152
K072250Supercable Grip and Plate SystemKinamed, Inc.20071

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, K120772 (Zimmer GmbH, 2012) has gone furthest, with 6 descendants of its own.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—
Cite this page

510(k) Report. “K000734: Pioneer Surgical Technology Extended GTR, Model 501-601.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000734

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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