510(k) Report

510(k) · Cleared

Cleared

Cabling System Trochanter Hook

K043252510(k) TraditionalCleared Jan 14, 200552-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

Smith & Nephew, Inc. · JDQ Cerclage, Fixation

Cleared on Jan 14, 2005 as substantially equivalent to K031162 (Smith & Nephew, Inc., 2003) and 3 other predicates after a 52-day review. Its family tree reaches back 5 generations to 1985. 1 later device descends from it.

Decided
Jan 14, 2005
Review
52 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K844068 (1985). 22 ancestors in all, the oldest K842977 (1984). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1996: 1 other ancestor1998: 2 other ancestors1997: 3 other ancestors1994: 3 other ancestors1993: 1 other ancestor1992: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor1984: 1 other ancestor1995: 2 other ancestors2013: 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. · 1997K982545 · BMP Cable System · Biomet, Inc. · 1998 · recalledK031162 · Smith & Nephew Orthopaedic Cabling System · Smith & Nephew, Inc. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 11 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant K031162 · Smith & Nephew Orthopaedic Cabling System · Smith & Nephew, Inc. · 2003K982545 · BMP Cable System · Biomet, Inc. · 1998 · recalledK971741 · 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. · 1985−50
  1. Root · 5 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
  2. 4 generations backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
  3. 3 generations backK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
  4. 2 generations backK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
  5. 1 generation backK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
  6. This deviceK043252 Cabling System Trochanter HookSmith & Nephew, Inc. · 2005
  7. Descendant · cites it directly · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K844068Trochanter Cable Grip SystemHowmedica Corp.1985—
−4K961569Dall-Miles Stainless Steel Beaded CableHowmedica Corp.1996—
−3K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp.1997—
−2K982545BMP Cable SystemBiomet, Inc.19981
−1K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.2003—
0 (this device)K043252Cabling System Trochanter HookSmith & Nephew, Inc.2005—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198810
199010
199210
199310
199430
199520
199610
199730
199820
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K043252, 1985–2013Source: 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
*K031162Smith & Nephew Orthopaedic Cabling System
Summary page 1
…1-4V. The trochanteric hook is used in conjunction with 2.0mm diameter cobalt chrome cables and cobalt chrome clamps from the Smith & Nephew Orthopaedics Cabling System (K031 162). The trochanteric hook features one hook to attach to the trochanter and one hole to allow a cable to be routed through the devi…
Smith & Nephew, Inc.2003—
*K984432Dall-Miles Cable Grip (a-Grip)
Summary page 1
…o allow a cable to be routed through the device and a clamp to secure the cable. The Cabling System Trochanteric Hook is similar to the Howmedica Dali-Miles Cable Grip (K984432), Pioneer System Greater Trochanteric Reattachment Device (K961267) and the Biomet BMP Cable System (K982545) in that all devices…
Howmedica Osteonics Corp.1999—
*K961267Pioneer System GTR (Greater Trochanteer Reattachment) Device
Summary page 1
…re the cable. The Cabling System Trochanteric Hook is similar to the Howmedica Dali-Miles Cable Grip (K984432), Pioneer System Greater Trochanteric Reattachment Device (K961267) and the Biomet BMP Cable System (K982545) in that all devices are used with cables and clamps for trochanteric reattachment when…
Pioneer Surgical Technology1996—
*K982545BMP Cable System
Summary page 1
…eric Hook is similar to the Howmedica Dali-Miles Cable Grip (K984432), Pioneer System Greater Trochanteric Reattachment Device (K961267) and the Biomet BMP Cable System (K982545) in that all devices are used with cables and clamps for trochanteric reattachment whenever the trochanter is osteotomized. The…
Biomet, Inc.19981
*—Smith & Nephew Hook Plate
Named without a submission number
—

Also cleared against K031162: 6 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20130

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 20 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
  • 2 of the 22 ancestors have a recall of any class.
  • Of its descendants, K123598 (Smith & Nephew, Inc., 2013) has gone furthest, with 0 descendants of its own.
  • 6 other devices also cite its predicate K031162.

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?

Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below.

1. Primary total hip arthroplasty

2. Revision total hip arthroplasty

3. Any procedure using anterolateral or lateral approaches

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K043252: Cabling System Trochanter Hook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043252

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