510(k) Report

510(k) · Cleared

Cleared

Cable Ready Cable Grip System Cable Button

K091799510(k) TraditionalCleared Sep 11, 200986-day reviewClass II21 CFR 888.3030

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

Zimmer, Inc. · HTN Washer, Bolt Nut

Cleared on Sep 11, 2009 as substantially equivalent to K992617 (Pioneer Surgical Technology, 1999) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 1997. 7 later devices descend from it.

Decided
Sep 11, 2009
Review
86 days
Class
Class II
Product code
HTN
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K974016 (1997). 4 ancestors in all, the oldest K953777 (1996). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor2012: 1 descendant cleared2021: 2 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant clearedK974016 · Cerclage Cable with Hex Button · Pioneer Surgical Technology · 1997K992617 · Hex Button · Pioneer Surgical Technology · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 1 descendant K992617 · Hex Button · Pioneer Surgical Technology · 1999K974016 · Cerclage Cable with Hex Button · Pioneer Surgical Technology · 19970
  1. Root · 2 generations backK974016 Cerclage Cable with Hex ButtonPioneer Surgical Technology · 1997
  2. 1 generation backK992617 Hex ButtonPioneer Surgical Technology · 1999
  3. This deviceK091799 Cable Ready Cable Grip System Cable ButtonZimmer, Inc. · 2009
  4. Descendant · cites it directly · 6 of its ownK120772 NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button…Zimmer GmbH · 2012 · Recalled
  5. Descendant · 2 generations on · 1 of its ownK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
  6. Descendant · 2 generations on · 0 of its ownK261038 Xpert PFPNewclip Technics · 2026
  7. Descendant · 2 generations on · 0 of its ownK241754 NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate…Zimmer Switzerland Manufacturing GmbH · 2024
  8. Descendant · 3 generations on · 0 of its ownK230764 OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012: 12017: 12021: 22023: 12024: 12026: 1
2012high 2 (2021) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · See all
  • K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH · 2012 · cites it directly6descendants
  • K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021 · 2 generations on1descendant
  • K261038Xpert PFPNewclip Technics · 2026 · 2 generations on0descendants
  • K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH · 2024 · 2 generations on0descendants
  • K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K974016Cerclage Cable with Hex ButtonPioneer Surgical Technology1997—
−1K992617Hex ButtonPioneer Surgical Technology1999—
0 (this device)K091799Cable Ready Cable Grip System Cable ButtonZimmer, Inc.2009—
+1K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB…Zimmer GmbH20122
+2K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021—
+2K261038Xpert PFPNewclip Technics2026—
+2K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System…Zimmer Switzerland Manufacturing GmbH2024—
+3K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201710
202120
202310
202410
202610
FIG. 1 — Lineage of K091799, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HTN? 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 HTN device

  1. #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.5 · 6 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K992617Hex Button
Summary page 1
…21 CFR § 888.3030 Predicate Device: Hex Button, manufactured by Pioneer Laboratories, K9926 17, cleared October 27, 1999. Cerclage Positioning Pin, manufactured by Synthes,…
Pioneer Surgical Technology1999—
*K992891Synthes Cerclage Positioning Pin
Summary page 1
…26 17, cleared October 27, 1999. Cerclage Positioning Pin, manufactured by Synthes, K99289 1, cleared November 2, 1999. Device Description: The Cable-Ready Cable Grip System Cable Button…
Synthes (Usa)1999—

Also cleared against K992617: 2 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH20126

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 12 years and passes through 2 companies; a new generation was cleared every 9.9 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K120772 (Zimmer GmbH, 2012) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K992617.

How does its category compare?

All HTN devices

HTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HTN

4in 2025

2007: 12008: 22009: 32011: 42013: 32014: 82015: 22016: 12017: 62018: 22019: 52020: 32021: 22022: 52023: 22024: 62025: 42026 (partial year): 2
2007high 8 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTN

75in 2025

2009: 86 days median2011: 130 days median2013: 105 days median2014: 98 days median2017: 88 days median2019: 116 days median2020: 87 days median2022: 86 days median2024: 90 days median2025: 75 days median
2007high 130 (2011) · low 75 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HTN

1in 2019

2013: 12019: 1
2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HTN

190in 2025

2007: 142008: 112009: 222010: 172011: 122012: 692013: 452014: 332015: 352016: 432017: 302018: 482019: 532020: 812021: 1492022: 852023: 1082024: 2692025: 190
2007high 269 (2024) · low 11 (2008)2025

MAUDE reports naming product code HTN, 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
20071—014
20082—011
2009386022
20100—017
20114130012
20120—069
20133105145
2014898033
20152—035
20161—043
2017688030
20182—048
20195116153
2020387081
20212—0149
2022586085
20232—0108
20246900269
20254750190
20262—0—

What is it indicated for?

The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in long bones.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K091799: Cable Ready Cable Grip System Cable Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091799

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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