510(k) Report

510(k) · Cleared

Cleared

ACCORD Cable System

K233949510(k) TraditionalCleared Mar 13, 202490-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 Mar 13, 2024 as substantially equivalent to K223762 (Smith & Nephew, 2023) and 2 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1985.

Decided
Mar 13, 2024
Review
90 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K844068 (1985). 21 ancestors in all, the oldest K842977 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1997: 3 other ancestors1993: 1 other ancestor1988: 1 other ancestor1984: 1 other ancestor1998: 1 other ancestor1995: 2 other ancestors1994: 3 other ancestors1992: 1 other ancestor1990: 1 other ancestorK844068 · 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. · 2003K223762 · Smith & Nephew ACCORD™ Cable System · Smith & Nephew · 202319801990200020102020
  1. Root · 6 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
  2. 5 generations backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
  3. 4 generations backK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
  4. 3 generations backK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
  5. 2 generations backK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
  6. 1 generation backK223762 Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023
  7. This deviceK233949 ACCORD Cable SystemSmith & Nephew, Inc. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K844068Trochanter Cable Grip SystemHowmedica Corp.1985—
−5K961569Dall-Miles Stainless Steel Beaded CableHowmedica Corp.1996—
−4K971741Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp.1997—
−3K982545BMP Cable SystemBiomet, Inc.19981
−2K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.2003—
−1K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew2023—
0 (this device)K233949ACCORD Cable SystemSmith & Nephew, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198810
199010
199210
199310
199430
199520
199730
199810
199910
FIG. 1 — Lineage of K233949, 1985–2024Source: 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? (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
*K223762Smith & Nephew ACCORD™ Cable System
Summary page 4
…ber 888.3010 Product Code JDQ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223762 Smith & Nephew ACCORD Cable System JDQ K031162 Smith & Nephew Orthopaedic Cabling System JDQ K993106 Smith & Nephew Bone Plate Sy…
Smith & Nephew2023—
*K031162Smith & Nephew Orthopaedic Cabling System
Summary page 4
…ed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223762 Smith & Nephew ACCORD Cable System JDQ K031162 Smith & Nephew Orthopaedic Cabling System JDQ K993106 Smith & Nephew Bone Plate System HRS Device Description Summary 21 CFR 807.…
Smith & Nephew, Inc.2003—
*K993106Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)
Summary page 4
…redicate Trade Name (Primary Predicate is listed first) Product Code K223762 Smith & Nephew ACCORD Cable System JDQ K031162 Smith & Nephew Orthopaedic Cabling System JDQ K993106 Smith & Nephew Bone Plate System HRS Device Description Summary 21 CFR 807.92(a)(4) The purpose of this Traditional 510(k) is to…
Smith & Nephew, Inc.1999—

What descends from it?

No later submission names this one as a predicate yet.

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 39 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
  • 2 of the 21 ancestors have a recall of any class.

How does its category compare?

All JDQ devices

JDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

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 Smith & Nephew ACCORD Cable System is indicated for use in general orthopaedic repair procedures including general cerclage of the femur, trochanteric reattachment, fixation of fractures in conjunction with intramedullary prosthesis (i.e., femoral stem) and screw fixation techniques.

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. “K233949: ACCORD Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233949

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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