510(k) · Cleared
ClearedEVOS Cabling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · JDQ Cerclage, Fixation
Cleared on Oct 28, 2020 as substantially equivalent to K031162 (Smith & Nephew, Inc., 2003) and 1 other predicate after a 145-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Oct 28, 2020
- Review
- 145 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K844068 (1985). 21 ancestors in all, the oldest K842977 (1984). No later device cites it as a predicate yet.
- 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 deviceK201497 EVOS Cabling SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 2020
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) | K201497 | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 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 |
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? (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 |
|---|---|---|---|
| * | K031162 | Smith & Nephew Orthopaedic Cabling SystemSummary page 4…per 21 CFR 888.3010 Product code JDQ Panel Orthopedic Device Panel Predicate Primary Predicate: Orthopedic Cabling System (K031162) Additional Predicate: SDB Cerclage System (K992616) Description of The EVOS Cabling System is used in… | 2003 |
| * | K992616 | SDB Cerclage SystemSummary page 4…Orthopedic Device Panel Predicate Primary Predicate: Orthopedic Cabling System (K031162) Additional Predicate: SDB Cerclage System (K992616) Description of The EVOS Cabling System is used in orthopedic trauma and Device reconstructive surgeries to re… | 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 35 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 21 ancestors have a recall of any class.
- 6 other devices also cite its predicate K031162.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
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?
The EVOS Cabling System is intended to be used in 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201497: EVOS 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/K201497
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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