510(k) · Cleared
ClearedSmith & Nephew ACCORD™ Cable System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew · HRS Plate, Fixation, Bone
Cleared on May 30, 2023 as substantially equivalent to K993106 (Smith & Nephew, Inc., 1999) and 1 other predicate after a 166-day review. Its family tree reaches back 5 generations to 1985. 1 later device descends from it.
- Decided
- May 30, 2023
- Review
- 166 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K844068 (1985). 20 ancestors in all, the oldest K842977 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
- 4 generations backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
- 3 generations backK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
- 2 generations backK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
- 1 generation backK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
- This deviceK223762 Smith & Nephew ACCORD™ Cable SystemSmith & Nephew · 2023
- Descendant · cites it directly · 0 of its ownK233949 ACCORD Cable SystemSmith & Nephew, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233949ACCORD Cable SystemSmith & Nephew, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844068 | Trochanter Cable Grip System | Howmedica Corp. | 1985 | — |
| −4 | K961569 | Dall-Miles Stainless Steel Beaded Cable | Howmedica Corp. | 1996 | — |
| −3 | K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable | Howmedica Corp. | 1997 | — |
| −2 | K982545 | BMP Cable System | Biomet, Inc. | 1998 | 1 |
| −1 | K031162 | Smith & Nephew Orthopaedic Cabling System | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | K223762 | Smith & Nephew ACCORD™ Cable System | Smith & Nephew | 2023 | — |
| +1 | K233949 | ACCORD Cable System | Smith & Nephew, Inc. | 2024 | — |
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 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 4…es: • Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) (K993106 S.E. 12/09/1999) • Smith & Nephew Orthopaedic Cabling Syste… | 1999 |
| * | K031162 | Smith & Nephew Orthopaedic Cabling SystemSummary page 4…(K993106 S.E. 12/09/1999) • Smith & Nephew Orthopaedic Cabling SystemK031162 (S.E. 05/01/2003) K223762… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233949 | ACCORD Cable System | 2024 | 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 38 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K233949 (Smith & Nephew, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 35 other devices also cite its predicate K993106.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Smith & Nephew Cabling System of the Smith & Nephew ACCORD™ Cable System is indicated for general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques. Trochanteric reattachment whenever the trochanter is…
Read the full statement (145 words)
The Smith & Nephew Cabling System of the Smith & Nephew ACCORD™ Cable System is indicated for general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.
Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below.
• Primary total hip arthroplasty.
• Revision total hip arthroplasty.
• Any procedure using anterolateral or lateral approaches.
The ACCORD™ Titanium Plates of the Smith & Nephew ACCORD™ Cable System are indicated for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223762: Smith & Nephew 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/K223762
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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