510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables

K151907510(k) TraditionalCleared Dec 30, 2015170-day reviewClass II21 CFR 888.3030Recalls 1

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

Zimmer, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Dec 30, 2015 as substantially equivalent to K961267 (Pioneer Surgical Technology, 1996) and 2 other predicates after a 170-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it. It has been recalled once.

Decided
Dec 30, 2015
Review
170 days
Class
Class II
Product code
KTT
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K935481 (1994). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1996: 1 other ancestor2017: 1 descendant cleared2026: 1 descendant clearedK935481 · Sponger Cable System, Modification · Pioneer Surgical Technology · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants K935481 · Sponger Cable System, Modification · Pioneer Surgical Technology · 19940
  1. Root · 1 generation backK935481 Sponger Cable System, ModificationPioneer Surgical Technology · 1994
  2. This deviceK151907 Cable-Ready® Cable Grip System: Cable-Ready® GTR System…Zimmer, Inc. · 2015
  3. Descendant · cites it directly · 0 of its ownK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
  4. Descendant · cites it directly · 0 of its ownK163003 Y3 Proximal Femoral Plate SystemPega Medical, Inc. · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026 · cites it directly0descendants
  • K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K935481Sponger Cable System, ModificationPioneer Surgical Technology1994—
0 (this device)K151907Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm…Zimmer, Inc.2015—
+1K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.2026—
+1K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202610
FIG. 1 — Lineage of K151907, 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), 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 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
  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
*K961267Pioneer System GTR (Greater Trochanteer Reattachment) Device
Summary page 5
…fixation Regulation Number: CFR 888.3010 Classification Number: 87 JDQ Orthopedics/87 Pioneer System GTR (Greater Trochanter Reattachment) (Pioneer Laboratories. Inc.. K961267. cleared 6/27/96) Extended GTR Device (Pioneer Surgical Technology. K000734, cleared 5/5/00) Device Description:…
Pioneer Surgical Technology1996—
*K000734Pioneer Surgical Technology Extended GTR, Model 501-601
Summary page 5
…pedics/87 Pioneer System GTR (Greater Trochanter Reattachment) (Pioneer Laboratories. Inc.. K961267. cleared 6/27/96) Extended GTR Device (Pioneer Surgical Technology. K000734, cleared 5/5/00) Device Description: Intended Use: Comparison to Predicate Device: K151907 Page 2 of 3 Songer…
Pioneer Surgical Technology2000—
*K935481Sponger Cable System, Modification
Summary page 6
…734, cleared 5/5/00) Device Description: Intended Use: Comparison to Predicate Device: K151907 Page 2 of 3 Songer Cable System (Pioneer Laboratories. K935481. cleared 1/26/94) The Cable-Ready Greater Trochanter Reattachment Short and Long (GTR) devices are used in combination with 1.8m…
Pioneer Surgical Technology1994—

Also cleared against K961267: 2 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260
K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 10, 2019Class IIZ-0327-2020Packaging change controlNon-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

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, K261271 (Pioneer Surgical Technology, Inc., 2026) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K961267.

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. 2015, this device’s year, is highlighted.

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—

What is it indicated for?

Cable-Ready® GTR System - The Cable-Ready® GTR System is indicated for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally, the device is used to reattach the greater trochanter following fracture of the greater trochanter. nonunion of fracture. or previous osteotomy.

Cable-Ready® 1.8mm Cerclage Cables - The 1.8mm cerclage cable can be used to secure fractures of the olecranon, patella, femur, humerus, and ankle. as well as to reduce and secure acromioclavicular dislocations. The 1.8mm cables can also be used to reattach the greater trochanter after trochanteric osteotomy during total hip arthroplasty.

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

Cite this page

510(k) Report. “K151907: Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151907

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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