510(k) · Cleared
ClearedPioneer System GTR (Greater Trochanteer Reattachment) Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · JDQ Cerclage, Fixation
Cleared on Jun 27, 1996 after an 86-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Jun 27, 1996
- Review
- 86 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK961267 Pioneer System GTR (Greater Trochanteer Reattachment) DevicePioneer Surgical Technology · 1996
- Descendant · cites it directly · 2 of its ownK151907 Cable-Ready® Cable Grip System: Cable-Ready® GTR System…Zimmer, Inc. · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK072250 Supercable Grip and Plate SystemKinamed, Inc. · 2007 · Recalled
- Descendant · cites it directly · 1 of its ownK043252 Cabling System Trochanter HookSmith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261038 Xpert PFPNewclip Technics · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151907Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage…Zimmer, Inc. · 2015 · cites it directly2descendants
- K072250Supercable Grip and Plate SystemKinamed, Inc. · 2007 · cites it directly1descendant
- K043252Cabling System Trochanter HookSmith & Nephew, Inc. · 2005 · cites it directly1descendant
- K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026 · 2 generations on0descendants
- K261038Xpert PFPNewclip Technics · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961267 | Pioneer System GTR (Greater Trochanteer Reattachment) Device | Pioneer Surgical Technology | 1996 | — |
| +1 | K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm… | Zimmer, Inc. | 2015 | 1 |
| +1 | K072250 | Supercable Grip and Plate System | Kinamed, Inc. | 2007 | 1 |
| +1 | K043252 | Cabling System Trochanter Hook | Smith & Nephew, Inc. | 2005 | — |
| +2 | K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | 2026 | — |
| +2 | K261038 | Xpert PFP | Newclip Technics | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 2 | 0 |
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 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Dall-Miles Trochanter Cable Grip Named without a submission number |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K151907 (Zimmer, Inc., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GTR Device is used 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961267: Pioneer System GTR (Greater Trochanteer Reattachment) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961267
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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