510(k) · Cleared
ClearedSmith & Nephew Orthopaedic Cabling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JDQ Cerclage, Fixation
Cleared on May 1, 2003 as substantially equivalent to K842977 (Richards Medical Co., Inc., 1984) and 5 other predicates after a 17-day review. Its family tree reaches back 4 generations to 1985. 10 later devices descend from it.
- Decided
- May 1, 2003
- Review
- 17 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K844068 (1985). 18 ancestors in all, the oldest K842977 (1984). 10 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
- 3 generations backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
- 2 generations backK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
- 1 generation backK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
- This deviceK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK223762 Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023
- Descendant · cites it directly · 1 of its ownK043252 Cabling System Trochanter HookSmith & Nephew, Inc. · 2005
- Descendant · 3 generations on · 0 of its ownK252019 CurvaFix Low Profile SystemCurvafix, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021 · cites it directly3descendants
- K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · 2 generations on2descendants
- K223762Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023 · cites it directly1descendant
- K043252Cabling System Trochanter HookSmith & Nephew, Inc. · 2005 · cites it directly1descendant
- K252019CurvaFix Low Profile SystemCurvafix, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K844068 | Trochanter Cable Grip System | Howmedica Corp. | 1985 | — |
| −3 | K961569 | Dall-Miles Stainless Steel Beaded Cable | Howmedica Corp. | 1996 | — |
| −2 | K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable | Howmedica Corp. | 1997 | — |
| −1 | K982545 | BMP Cable System | Biomet, Inc. | 1998 | 1 |
| 0 (this device) | K031162 | Smith & Nephew Orthopaedic Cabling System | Smith & Nephew, Inc. | 2003 | — |
| +1 | K203405 | EVOS Large Fragment Plating System | Smith & Nephew, Inc. | 2021 | — |
| +2 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
| +1 | K223762 | Smith & Nephew ACCORD™ Cable System | Smith & Nephew | 2023 | — |
| +1 | K043252 | Cabling System Trochanter Hook | Smith & Nephew, Inc. | 2005 | — |
| +3 | K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K842977 | Orthopaedic Cable SystemSummary page 1…equivalence in intended use, materials, design, operational principles and indications to the following predicate devices - Smith & Nephew’s Orthopaedic Cable Systems (K842977, K87S 156, K924141), Biomet’s BMP Cable System (K982545), Howmedica’s Dall-Miles Cable System (K97 1741), Pioneer’s Cerclage Ca… | 1984 |
| * | K875156 | Stainless Steel Orthopaedic Cable System | 1988 |
| * | K924141 | Orthopaedic Polyethylene CableSummary page 1…ended use, materials, design, operational principles and indications to the following predicate devices - Smith & Nephew’s Orthopaedic Cable Systems (K842977, K87S 156, K924141), Biomet’s BMP Cable System (K982545), Howmedica’s Dall-Miles Cable System (K97 1741), Pioneer’s Cerclage Cable with Hex Button… | 1993 |
| * | K982545 | BMP Cable SystemSummary page 1…nal principles and indications to the following predicate devices - Smith & Nephew’s Orthopaedic Cable Systems (K842977, K87S 156, K924141), Biomet’s BMP Cable System (K982545), Howmedica’s Dall-Miles Cable System (K97 1741), Pioneer’s Cerclage Cable with Hex Button (K974016), and Zirnmer’s Cable-Ready… | 1998 |
| * | K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableSummary page 1…predicate devices - Smith & Nephew’s Orthopaedic Cable Systems (K842977, K87S 156, K924141), Biomet’s BMP Cable System (K982545), Howmedica’s Dall-Miles Cable System (K97 1741), Pioneer’s Cerclage Cable with Hex Button (K974016), and Zirnmer’s Cable-Ready Cable Grip System. Device Description The Smi… | 1997 |
| * | K974016 | Cerclage Cable with Hex ButtonSummary page 1…le Systems (K842977, K87S 156, K924141), Biomet’s BMP Cable System (K982545), Howmedica’s Dall-Miles Cable System (K97 1741), Pioneer’s Cerclage Cable with Hex Button (K974016), and Zirnmer’s Cable-Ready Cable Grip System. Device Description The Smith & Nephew Orthopaedic Cabling System consists of a… | 1997 |
| * | — | Zimmer’s Cable-Ready Cable Grip System Named without a submission number |
What descends from it? (10)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203405 | EVOS Large Fragment Plating System | 2021 | 3 |
| K223762 | Smith & Nephew ACCORD™ Cable System | 2023 | 1 |
| K043252 | Cabling System Trochanter Hook | 2005 | 1 |
| K233949 | ACCORD Cable System | 2024 | 0 |
| K201497 | EVOS Cabling System | 2020 | 0 |
| K173910 | Impress SFS System | 2018 | 0 |
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K203405 (Smith & Nephew, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K842977.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing fixation techniques.
Trochanteric reattachment whenever the trochanter is osteomized 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.
https://510kreport.com/device/K031162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031162: Smith & Nephew Orthopaedic Cabling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031162
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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