510(k) · Cleared
ClearedCable-Ready Cable Grip System: Cable-Ready Bone Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HRS Plate, Fixation, Bone
Cleared on Jan 28, 2016 as substantially equivalent to K940729 (Pioneer Surgical Technology, 1994) and 1 other predicate after a 217-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jan 28, 2016
- Review
- 217 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940729 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK940729 Pioneer Laboratories Bone Plate with Cerclage CablesPioneer Surgical Technology · 1994
- This deviceK151716 Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemZimmer, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940729 | Pioneer Laboratories Bone Plate with Cerclage Cables | Pioneer Surgical Technology | 1994 | — |
| 0 (this device) | K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate System | Zimmer, Inc. | 2016 | — |
| +1 | K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K940729 | Pioneer Laboratories Bone Plate with Cerclage CablesSummary page 4…JDQ Classification Panel: Orthopedics/87 Predicate Device(s): Pioneer Laboratories Bone Plate with Cerclage Cable, Pioneer Laboratories, K940729, cleared December 27, 1994 Pioneer Laboratories Bone Plate with Cable’s Device,… | 1994 |
| * | K972223 | Bone Plate with CablesSummary page 4…red December 27, 1994 Pioneer Laboratories Bone Plate with Cable’s Device, Pioneer Laboratories, K972223, cleared September 10, 1997 K15171… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261271 | Cable-Ready® Cable Grip System | 2026 | 0 |
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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Cable-Ready® Bone Plate with Cerclage Cable is indicated for use where wire, cable, or band cerclage is used in combination with bone plates to provide fixation and/or stabilization of long bones - femur, tibia and humerus. Examples include periprosthetic fractures or bone loss, comminuted shaft fractures, and nonunions of previous fractures with or without failed hardware.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151716: Cable-Ready Cable Grip System: Cable-Ready Bone Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151716
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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