510(k) Report

510(k) · Cleared

Cleared

Dall-Miles Homogenous Vitallium Cable

K961283510(k) TraditionalCleared May 22, 199649-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 May 22, 1996 as substantially equivalent to K953818 (Howmedica Corp., 1995) and 2 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1988. 28 later devices descend from it.

Decided
May 22, 1996
Review
49 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K875156 (1988). 3 ancestors in all. 28 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 1 other ancestor2017: 1 descendant cleared2020: 2 descendants cleared1997: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2024: 4 descendants cleared2023: 6 descendants cleared2026: 4 descendants cleared1998: 1 descendant cleared2025: 5 descendants cleared2006: 1 descendant cleared2009: 1 descendant clearedK875156 · Stainless Steel Orthopaedic Cable System · Richards Medical Co., Inc. · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 10 descendants4 generations forward: 6 descendants5 generations forward: 2 descendants K875156 · Stainless Steel Orthopaedic Cable System · Richards Medical Co., Inc. · 19880+5
  1. Root · 1 generation backK875156 Stainless Steel Orthopaedic Cable SystemRichards Medical Co., Inc. · 1988
  2. This deviceK961283 Dall-Miles Homogenous Vitallium CableHowmedica Corp. · 1996
  3. Descendant · cites it directly · 17 of its ownK172350 AxSOS 3 TiStryker GmbH · 2017
  4. Descendant · 2 generations on · 11 of its ownK181091 AxSOS 3 TiStryker GmbH · 2018
  5. Descendant · 3 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
  6. Descendant · 4 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
  7. Descendant · cites it directly · 8 of its ownK202016 Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12006: 12009: 12017: 12018: 12020: 22022: 12023: 62024: 42025: 52026: 4
1997high 6 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 28 · See all
  • K172350AxSOS 3 TiStryker GmbH · 2017 · cites it directly17descendants
  • K181091AxSOS 3 TiStryker GmbH · 2018 · 2 generations on11descendants
  • K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 3 generations on9descendants
  • K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 4 generations on8descendants
  • K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020 · cites it directly8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K875156Stainless Steel Orthopaedic Cable SystemRichards Medical Co., Inc.1988—
0 (this device)K961283Dall-Miles Homogenous Vitallium CableHowmedica Corp.1996—
+1K172350AxSOS 3 TiStryker GmbH2017—
+2K181091AxSOS 3 TiStryker GmbH2018—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH2020—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker…Stryker GmbH2023—
+1K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200610
200910
201710
201810
202020
202210
202360
202440
202550
202640
FIG. 1 — Lineage of K961283, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K953818Dall-Miles Suture/Beaded Cable
Summary page 1
…es of the Dall-Miles Cable. Substantial equivalence of the additional indications is based on equivalence in intended use to Howmedica's Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557). Each of the named devices are…
Howmedica Corp.1995—
*K875156Stainless Steel Orthopaedic Cable System
Summary page 1
…f the additional indications is based on equivalence in intended use to Howmedica's Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557). Each of the named devices are currently marketed for stabilization of bone graft an…
Richards Medical Co., Inc.1988—
*K934557Control Cable System
Summary page 1
…ivalence in intended use to Howmedica's Dall-Miles Suture/Beaded Cable (K953818), Smith & Nephew Richards' Ries Cable System (K875156), and Depuy's Control Cable System (K934557). Each of the named devices are currently marketed for stabilization of bone graft and fracture fixation.
Depuy, Inc.1994—

Also cleared against K953818: 3 other devices →

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K172350AxSOS 3 TiStryker GmbH201717
K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20208
K972327Metagen Activelock Cerclage SystemPacific Materials and Interfaces19973

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 3 ancestors has a recall.
  • Of its descendants, K172350 (Stryker GmbH, 2017) has gone furthest, with 17 descendants of its own.
  • 3 other devices also cite its predicate K953818.

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 original Homogeneous cable is intended to be used for spinal wiring, trochanter reattachment, sternotomy applications and trauma surgery of the shoulder, elbow, knee, hip, or ankle. Indications for the stabilization of bone graft material and for fracture fixation when used in conjunction with bone plates and screws have been added.

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 K953818

3 other devices cite the same predicate.

  • K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
  • K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
  • K961569Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996

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/K961283 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961283: Dall-Miles Homogenous Vitallium Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961283

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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