510(k) · Cleared
ClearedCable-Ready® Cable Grip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. · JDQ Cerclage, Fixation
Cleared on Jul 16, 2026 as substantially equivalent to K151907 (Zimmer, Inc., 2015) and 3 other predicates after a 90-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- Jul 16, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K962616 (1996). 107 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
- 2 generations backK150889 Suture Wires and Wire LoopsZimmer, Inc. · 2015
- 1 generation backK151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready…Zimmer, Inc. · 2016
- This deviceK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
- 3 generations backK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
- 2 generations backK150889 Suture Wires and Wire LoopsZimmer, Inc. · 2015
- 1 generation backK151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready…Zimmer, Inc. · 2016
- This deviceK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K060156 | Straight Plate with Angular Stability & Screw System | I.T.S. Implantat-Technologie-Systeme GmbH | 2006 | 2 |
| −3 | K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | Ortho Solutions Limited | 2011 | — |
| −2 | K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | 2015 | — |
| −1 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle… | Zimmer, Inc. | 2016 | — |
| 0 (this device) | K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 12 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 11 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 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 K202016 Dall-Miles® Cable Systemscore 12.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151907 | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage…Summary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K151907 Cable-Ready® Cable Grip System: Cable-Ready® 1.8mm Cerclage Cables… | 2015 |
| * | K992617 | Hex Button | 1999 |
| Kept off the family tree | K000734 | FDA’s K000734 is Pioneer Surgical Technology Extended GTR, Model 501-601 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| * | K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemSummary page 5…~K_n_ _ _~ K151907 Cable-Ready® Cable Grip System: Cable-Ready® GTR System KTT K151716 Cable-Ready® Cable Grip System: Cable-Ready Bone Plate HRS… | 2016 |
| * | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemSummary page 5…KTT K151716 Cable-Ready® Cable Grip System: Cable-Ready Bone Plate HRS System I K151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System H_W_C_ _ __,… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 18 of the 107 ancestors have a recall of any class.
- 1 other device also cites its predicate K151907.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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?
Cerclage Cable with Crimp The Cerclage Cable with Crimp is indicated for use in skeletally mature patients to secure fractures of the olecranon, patella, femur, and humerus. The Cerclage Cable with Crimp can also be used in skeletally mature patients to reattach the greater trochanter after trochanteric osteotomy during total hip arthroplasty. Needle Cable The Needle Cable is indicated for use in skeletally mature patients for securing fractures of the…
Read the full statement (280 words)
Cerclage Cable with Crimp
The Cerclage Cable with Crimp is indicated for use in skeletally mature patients to secure fractures of the olecranon, patella, femur, and humerus. The Cerclage Cable with Crimp can also be used in skeletally mature patients to reattach the greater trochanter after trochanteric osteotomy during total hip arthroplasty.
Needle Cable
The Needle Cable is indicated for use in skeletally mature patients for securing fractures of the olecranon, patella, and humerus.
Cable Pin
The Cable Pin is indicated for use in skeletally mature patients for olecranon fractures, patellar fractures, proximal humerus fractures, and greater tuberosity humerus fractures.
Bone Plate with Cerclage Cable
The Bone Plate with Cerclage Cable is indicated for use in skeletally mature patients where wire, cable, or band cerclage is used in combination with bone plates to provide fixation and/or stabilization of long bones. Examples include periprosthetic fractures or bone loss, comminuted shaft fractures, and nonunions of previous fractures with or without failed hardware.
Greater Trochanter Reattachment (GTR) Device and GTR Cable
The Greater Trochanter Reattachment (GTR) Device (including cables) is indicated for use in skeletally mature patients for the reattachment of the greater trochanter following osteotomy in total hip replacement and for fracture of the greater trochanter. The Extended GTR is additionally indicated for use in skeletally mature patients for reattachment of the greater trochanter in periprosthetic fractures of the femur.
Hex Button
The Hex Button is an optional accessory that, when used with a cerclage cable/wire, is indicated for use in skeletally mature patients for the following :
• prevent cable migration and screw backout when interfaced with a screw
• prevent cable migration when interfaced with a locking cap or plate
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/K261271 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261271: Cable-Ready® Cable Grip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261271
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026