510(k) Report

510(k) · Cleared

Cleared

Orthopaedic Cable System

K842977510(k) TraditionalCleared Oct 26, 198488-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

Richards Medical Co., Inc. · JDQ Cerclage, Fixation

Cleared on Oct 26, 1984 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Oct 26, 1984
Review
88 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
0

11 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2003: 1 descendant cleared2020: 1 descendant cleared2023: 2 descendants cleared2018: 1 descendant cleared2005: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared19801990200020102020
  1. This deviceK842977 Orthopaedic Cable SystemRichards Medical Co., Inc. · 1984
  2. Descendant · cites it directly · 10 of its ownK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
  3. Descendant · 2 generations on · 3 of its ownK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
  4. Descendant · 3 generations on · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
  5. Descendant · 2 generations on · 1 of its ownK223762 Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023
  6. Descendant · 2 generations on · 1 of its ownK043252 Cabling System Trochanter HookSmith & Nephew, Inc. · 2005

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12013: 12018: 12020: 12021: 12022: 12023: 22024: 12025: 1
2003high 2 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all
  • K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003 · cites it directly10descendants
  • K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021 · 2 generations on3descendants
  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · 3 generations on2descendants
  • K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023 · 2 generations on1descendant
  • K043252Cabling System Trochanter HookSmith & Nephew, Inc. · 2005 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K842977Orthopaedic Cable SystemRichards Medical Co., Inc.1984—
+1K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.2003—
+2K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.2021—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100…Smith & Nephew, Inc.20221
+2K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew2023—
+2K043252Cabling System Trochanter HookSmith & Nephew, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
201310
201810
202010
202110
202210
202320
202410
202510
FIG. 1 — Lineage of K842977, 1984–2025Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc.200310
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?

  • Of its descendants, K031162 (Smith & Nephew, Inc., 2003) has gone furthest, with 10 descendants 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—
Cite this page

510(k) Report. “K842977: Orthopaedic Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K842977

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026