510(k) · Cleared
ClearedDall-Miles Homogeneous Stainless Steel Cable and Beaded Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JDQ Cerclage, Fixation
Cleared on Jul 16, 1997 as substantially equivalent to K844068 (Howmedica Corp., 1985) and 4 other predicates after a 65-day review. Its family tree reaches back 2 generations to 1985. 28 later devices descend from it.
- Decided
- Jul 16, 1997
- Review
- 65 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K844068 (1985). 7 ancestors in all. 28 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
- 1 generation backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
- This deviceK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
- Descendant · cites it directly · 17 of its ownK982545 BMP Cable SystemBiomet, Inc. · 1998 · Recalled
- Descendant · cites it directly · 10 of its ownK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK202016 Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
- Descendant · 2 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 2 generations on · 3 of its ownK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K982545BMP Cable SystemBiomet, Inc. · 1998 · cites it directly17descendants
- K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003 · cites it directly10descendants
- K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020 · cites it directly8descendants
- K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
- K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844068 | Trochanter Cable Grip System | Howmedica Corp. | 1985 | — |
| −1 | K961569 | Dall-Miles Stainless Steel Beaded Cable | Howmedica Corp. | 1996 | — |
| 0 (this device) | K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable | Howmedica Corp. | 1997 | — |
| +1 | K982545 | BMP Cable System | Biomet, Inc. | 1998 | 1 |
| +1 | K031162 | Smith & Nephew Orthopaedic Cabling System | Smith & Nephew, Inc. | 2003 | — |
| +1 | K202016 | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020 | — |
| +2 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +2 | K203405 | EVOS Large Fragment Plating System | Smith & Nephew, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K844068 | Trochanter Cable Grip SystemSummary page 1…ubmission are modifications of the existing cable and beaded cable. The difference between the new stainless steel devices and’the existing cables cleared in submissions K844068 and K961569 is the material (22-13-5 ESR vs. 316L) and the manner in which the cable is manufactured (Homogeneous strands vs. Non… | 1985 |
| * | K900926 | Trochanter Cable Grip System (Add'l Indications)Summary page 1…lence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926); Dall-Miles Homogeneous Cable, Vitallium® (K945294); Dall- Miles Suture/Beaded Cable (K953818); and Dall-Miles Stainless Steel B… | 1990 |
| * | K945294 | Dall Miles System Homogeneous Vitallium CableSummary page 1…l principles, and indications and contraindications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926); Dall-Miles Homogeneous Cable, Vitallium® (K945294); Dall- Miles Suture/Beaded Cable (K953818); and Dall-Miles Stainless Steel Beaded Cable, 316L (K961569). RVICE,… | 1995 |
| * | K953818 | Dall-Miles Suture/Beaded CableSummary page 1…ications to Howmedica's Dall-Miles Trochanter Cable Grip System (K844068 & K900926); Dall-Miles Homogeneous Cable, Vitallium® (K945294); Dall- Miles Suture/Beaded Cable (K953818); and Dall-Miles Stainless Steel Beaded Cable, 316L (K961569). RVICE, St S, W ¢, & Yy S REALTH o o <O 4y, C DE… | 1995 |
| * | K961569 | Dall-Miles Stainless Steel Beaded CableSummary page 1…e modifications of the existing cable and beaded cable. The difference between the new stainless steel devices and’the existing cables cleared in submissions K844068 and K961569 is the material (22-13-5 ESR vs. 316L) and the manner in which the cable is manufactured (Homogeneous strands vs. Non- Homogeneou… | 1996 |
What descends from it? (28)
See all 285 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 1 company; a new generation was cleared every 11.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K982545 (Biomet, Inc., 1998) has gone furthest, with 17 descendants of its own.
- 5 other devices also cite its predicate K844068.
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?
The Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable are intended to be used for spinal wiring, sternotomy applications, cerclage procedures, and trauma surgery of the shoulder, elbow, knee, hip, or ankle. In addition, these cables may be used for supplementary fracture fixation when used with bone plates and screws and for the stabilization of bone graft material.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971741: Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971741
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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