510(k) Report

510(k) · Cleared

Cleared

Dall-Miles Cable Grip (a-Grip)

K984432510(k) TraditionalCleared Feb 24, 199972-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 Osteonics Corp. · JDQ Cerclage, Fixation

Cleared on Feb 24, 1999 as substantially equivalent to K980594 (Osteonics Corp., 1998) and 3 other predicates after a 72-day review. Its family tree reaches back 3 generations to 1985. 2 later devices descend from it.

Decided
Feb 24, 1999
Review
72 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K844068 (1985). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1990: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor1988: 1 other ancestor2005: 1 descendant cleared2013: 1 descendant clearedK844068 · Trochanter Cable Grip System · Howmedica Corp. · 1985K961569 · Dall-Miles Stainless Steel Beaded Cable · Howmedica Corp. · 1996K971741 · Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable · Howmedica Corp. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K971741 · Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable · Howmedica Corp. · 1997K961569 · Dall-Miles Stainless Steel Beaded Cable · Howmedica Corp. · 1996K844068 · Trochanter Cable Grip System · Howmedica Corp. · 19850
  1. Root · 3 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
  2. 2 generations backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
  3. 1 generation backK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
  4. This deviceK984432 Dall-Miles Cable Grip (a-Grip)Howmedica Osteonics Corp. · 1999
  5. Descendant · cites it directly · 1 of its ownK043252 Cabling System Trochanter HookSmith & Nephew, Inc. · 2005
  6. Descendant · 2 generations on · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K043252Cabling System Trochanter HookSmith & Nephew, Inc. · 2005 · cites it directly1descendant
  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K844068Trochanter Cable Grip SystemHowmedica Corp.1985—
−2K961569Dall-Miles Stainless Steel Beaded CableHowmedica Corp.1996—
−1K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp.1997—
0 (this device)K984432Dall-Miles Cable Grip (a-Grip)Howmedica Osteonics Corp.1999—
+1K043252Cabling System Trochanter HookSmith & Nephew, Inc.2005—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199410
199520
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201310
FIG. 1 — Lineage of K984432, 1985–2013Source: 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
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What was it cleared against? (4)

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
*K980594Osteonics FX-Cablelok Grip Components
Summary page 2
…is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Osteonics’ FX-Cablelok Grip Components (K980594) and Howmedica's Dall-Miles Trochanter Cable Grip System (K844068, KS00926, and KS71741). o gy ' & % __/C DEPARTM…
Osteonics Corp.1998—
*K844068Trochanter Cable Grip System
Summary page 2
…perational principles, and indications and contraindications to Osteonics’ FX-Cablelok Grip Components (K980594) and Howmedica's Dall-Miles Trochanter Cable Grip System (K844068, KS00926, and KS71741). o gy ' & % __/C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Priae)) ol…
Howmedica Corp.1985—
*K900926Trochanter Cable Grip System (Add'l Indications)
Our OCR of the scanned summary read K500926, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Howmedica's Dall-Miles Trochanter Cable Grip System”.
Howmedica Corp.1990—
*K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable
Our OCR of the scanned summary read K571741, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Howmedica's Dall-Miles Trochanter Cable Grip System”.
Howmedica Corp.1997—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K043252Cabling System Trochanter HookSmith & Nephew, Inc.20051

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 14 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K043252 (Smith & Nephew, Inc., 2005) has gone furthest, with 1 descendant of its own.

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 Cable Grip is intended to be used for the fixation of the greater trochanter secondary to osteotomy in total hip replacement, surface replacement arthroplasty, or any hip procedure requiring a trochanteric osteotomy.

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

Cite this page

510(k) Report. “K984432: Dall-Miles Cable Grip (a-Grip).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984432

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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