510(k) · Cleared
ClearedBone Plate with Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · HRS Plate, Fixation, Bone
Cleared on Sep 10, 1997 after an 89-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Sep 10, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK972223 Bone Plate with CablesPioneer Surgical Technology · 1997
- Descendant · cites it directly · 1 of its ownK151716 Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemZimmer, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK072250 Supercable Grip and Plate SystemKinamed, Inc. · 2007 · Recalled
- 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
Most influential descendants
Showing 4 of 4 · See all- K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate SystemZimmer, Inc. · 2016 · cites it directly1descendant
- K072250Supercable Grip and Plate SystemKinamed, Inc. · 2007 · 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) | K972223 | Bone Plate with Cables | Pioneer Surgical Technology | 1997 | — |
| +1 | K151716 | Cable-Ready Cable Grip System: Cable-Ready Bone Plate System | Zimmer, Inc. | 2016 | — |
| +1 | K072250 | Supercable Grip and Plate System | Kinamed, Inc. | 2007 | 1 |
| +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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Dall-Miles Cable Grip System Named without a submission number | |
| * | — | Dall-Miles Broad Bone Plate Named without a submission number | |
| * | — | Pioneer Laboratories Bone Plate with Cerclage Cables Named without a submission number |
What descends from it? (4)
2 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, K151716 (Zimmer, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Bone Plate with Cable’s device is indicated for use where wire, cable, or band cerclage is used in combination with bone plates. The Bone Plate with Cable’s device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the bone 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/K972223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972223: Bone Plate with Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972223
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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