510(k) Report

510(k) · Cleared

Cleared

Dall-Miles Stainless Steel Beaded Cable

K961569510(k) TraditionalCleared Jun 24, 199662-day reviewClass II21 CFR 888.3010

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

Howmedica Corp. · JDQ Cerclage, Fixation

Cleared on Jun 24, 1996 as substantially equivalent to K844068 (Howmedica Corp., 1985) and 4 other predicates after a 62-day review. Its family tree reaches back 1 generation to 1985. 33 later devices descend from it.

Decided
Jun 24, 1996
Review
62 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K844068 (1985). 5 ancestors in all. 33 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor1998: 2 descendants cleared2003: 3 descendants cleared1997: 2 descendants cleared1999: 1 descendant cleared2020: 2 descendants cleared2006: 1 descendant cleared2013: 1 descendant cleared2023: 4 descendants cleared2018: 1 descendant cleared2005: 1 descendant cleared2021: 1 descendant cleared2024: 3 descendants cleared2009: 1 descendant cleared2026: 3 descendants cleared2014: 1 descendant cleared2001: 1 descendant cleared2007: 1 descendant cleared2022: 1 descendant cleared2025: 3 descendants clearedK844068 · Trochanter Cable Grip System · Howmedica Corp. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 16 descendants4 generations forward: 6 descendants5 generations forward: 2 descendants K844068 · Trochanter Cable Grip System · Howmedica Corp. · 19850+5
  1. Root · 1 generation backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
  2. This deviceK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
  3. Descendant · cites it directly · 28 of its ownK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
  4. Descendant · 2 generations on · 17 of its ownK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
  5. Descendant · 2 generations on · 10 of its ownK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
  6. Descendant · 2 generations on · 8 of its ownK202016 Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
  7. Descendant · 3 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

1997: 21998: 21999: 12001: 12003: 32005: 12006: 12007: 12009: 12013: 12014: 12018: 12020: 22021: 12022: 12023: 42024: 32025: 32026: 3
1997high 4 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 33 · See all
  • K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997 · cites it directly28descendants
  • K982545BMP Cable SystemBiomet, Inc. · 1998 · 2 generations on17descendants
  • K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003 · 2 generations on10descendants
  • K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020 · 2 generations on8descendants
  • K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K844068Trochanter Cable Grip SystemHowmedica Corp.1985—
0 (this device)K961569Dall-Miles Stainless Steel Beaded CableHowmedica Corp.1996—
+1K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp.1997—
+2K982545BMP Cable SystemBiomet, Inc.19981
+2K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.2003—
+2K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2020—
+3K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199820
199910
200110
200330
200510
200610
200710
200910
201310
201410
201810
202020
202110
202210
202340
202430
202530
202630
FIG. 1 — Lineage of K961569, 1985–2026Source: 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 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. #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K844068Trochanter Cable Grip System
Summary page 1
…the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926) and Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Contr…
Howmedica Corp.1985—
*K900926Trochanter Cable Grip System (Add'l Indications)
Summary page 1
…lence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926) and Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable S…
Howmedica Corp.1990—
*K953818Dall-Miles Suture/Beaded Cable
Summary page 1
…rational principles, and indications and contraindications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926) and Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557).
Howmedica Corp.1995—
*K875156Stainless Steel Orthopaedic Cable System
Summary page 1
…ons to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926) and Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557).
Richards Medical Co., Inc.1988—
*K934557Control Cable System
Summary page 1
…le Grip System (K844068 & K900926) and Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557).
Depuy, Inc.1994—

Also cleared against K844068: 5 other devices →

What descends from it? (33)

See all 33

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp.199728
K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces19973
K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC19982
K023564Osse-LignOsseus, LLC20030

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K971741 (Howmedica Corp., 1997) has gone furthest, with 28 descendants of its own.
  • 5 other devices also cite its predicate K844068.

How does its category compare?

All JDQ devices

JDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDQ

2in 2025

2007: 12008: 22009: 22011: 62012: 32013: 12014: 22015: 52016: 42017: 12018: 62020: 42022: 22023: 32024: 32025: 22026 (partial year): 1
2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDQ

130in 2024

2011: 130 days median2012: 134 days median2015: 92 days median2016: 129 days median2018: 101 days median2020: 93 days median2023: 141 days median2024: 130 days median
2007high 141 (2023) · low 92 (2015)2026

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

Recalls per year · JDQ

5in 2019

2008: 22010: 22013: 12015: 12019: 5
2007high 5 (2019) · low 0 (2007)2026

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

Adverse event reports per year · JDQ

84in 2025

2007: 52008: 252009: 192010: 282011: 302012: 1302013: 3212014: 2232015: 2052016: 2242017: 1382018: 1822019: 1582020: 1252021: 1412022: 1342023: 982024: 1152025: 84
2007high 321 (2013) · low 5 (2007)2025

MAUDE reports naming product code JDQ, 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—05
20082—225
20092—019
20100—228
20116130030
201231340130
20131—1321
20142—0223
20155921205
201641290224
20171—0138
201861010182
20190—5158
20204930125
20210—0141
20222—0134
20233141098
202431300115
20252—084
20261—0—

What is it indicated for?

The Dall-Miles Beaded Cable is intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fixation when used with bone plates and screws and for the stabilization of bone graft material.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K844068

5 other devices cite the same predicate.

  • K992616SDB Cerclage SystemPioneer Surgical Technology · 1999
  • K984432Dall-Miles Cable Grip (a-Grip)Howmedica Osteonics Corp. · 1999
  • K983976Metagen Activelock Wire Cerclage SystemMetagen, LLC · 1998
  • K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces · 1997
  • K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

Recent decisions in JDQ

The JDQ category page

  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
  • K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
  • K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc. · 2025
  • K232733Mbrace CableMedacta International S.A. · 2024
  • K233949ACCORD Cable SystemSmith & Nephew, Inc. · 2024

https://510kreport.com/device/K961569 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961569: Dall-Miles Stainless Steel Beaded Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961569

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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