510(k) · Cleared
ClearedDall-Miles® Cable System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp., Dba Stryker Orthopaedics · JDQ Cerclage, Fixation
Cleared on Oct 16, 2020 as substantially equivalent to K070170 (Stryker Orthopaedics, 2007) and 6 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1985. 8 later devices descend from it.
- Decided
- Oct 16, 2020
- Review
- 87 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K844068 (1985). 14 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK844068 Trochanter Cable Grip SystemHowmedica Corp. · 1985
- 2 generations backK961569 Dall-Miles Stainless Steel Beaded CableHowmedica Corp. · 1996
- 1 generation backK971741 Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableHowmedica Corp. · 1997
- This deviceK202016 Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
- Descendant · cites it directly · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 2 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · cites it directly · 1 of its ownK231257 Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled
- Descendant · cites it directly · 0 of its ownK261481 Pangea Femur Reconstruction SystemStryker GmbH · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
- K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 2 generations on2descendants
- K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023 · cites it directly1descendant
- K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 2 generations on0descendants
- K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K844068 | Trochanter Cable Grip System | Howmedica Corp. | 1985 | — |
| −2 | K961569 | Dall-Miles Stainless Steel Beaded Cable | Howmedica Corp. | 1996 | — |
| −1 | K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded Cable | Howmedica Corp. | 1997 | — |
| 0 (this device) | K202016 | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020 | — |
| +1 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +2 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +1 | K231257 | Pangea Utility Plating System, Pangea Platform | Stryker GmbH | 2023 | — |
| +2 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | 2 |
| +1 | K261481 | Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K070170 | Dall-Miles SystemSummary page 4…ries (888.3030) Bone fixation cerclage (888.3010) Product Codes: HRS, JDQ, LYT, LRN Predicate Devices Primary Predicate Device: K070170 Additional Secondary Predicate Devices: K971741, K961283, K953818, K945294, K934058, and K900926 Product Name… | 2007 |
| * | K971741 | Dall-Miles Homogeneous Stainless Steel Cable and Beaded CableSummary page 4…ation cerclage (888.3010) Product Codes: HRS, JDQ, LYT, LRN Predicate Devices Primary Predicate Device: K070170 Additional Secondary Predicate Devices: K971741, K961283, K953818, K945294, K934058, and K900926 Product Name Previous Premarket… | 1997 |
| * | K961283 | Dall-Miles Homogenous Vitallium CableSummary page 4…clage (888.3010) Product Codes: HRS, JDQ, LYT, LRN Predicate Devices Primary Predicate Device: K070170 Additional Secondary Predicate Devices: K971741, K961283, K953818, K945294, K934058, and K900926 Product Name Previous Premarket… | 1996 |
| * | K953818 | Dall-Miles Suture/Beaded CableSummary page 4…8.3010) Product Codes: HRS, JDQ, LYT, LRN Predicate Devices Primary Predicate Device: K070170 Additional Secondary Predicate Devices: K971741, K961283, K953818, K945294, K934058, and K900926 Product Name Previous Premarket… | 1995 |
| * | K945294 | Dall Miles System Homogeneous Vitallium CableSummary page 4…Product Codes: HRS, JDQ, LYT, LRN Predicate Devices Primary Predicate Device: K070170 Additional Secondary Predicate Devices: K971741, K961283, K953818, K945294, K934058, and K900926 Product Name Previous Premarket… | 1995 |
| * | K934058 | Dall Miles System MinicleatSummary page 4…odes: HRS, JDQ, LYT, LRN Predicate Devices Primary Predicate Device: K070170 Additional Secondary Predicate Devices: K971741, K961283, K953818, K945294, K934058, and K900926 Product Name Previous Premarket… | 1994 |
| * | K900926 | Trochanter Cable Grip System (Add'l Indications)Summary page 4…HRS, JDQ, LYT, LRN Predicate Devices Primary Predicate Device: K070170 Additional Secondary Predicate Devices: K971741, K961283, K953818, K945294, K934058, and K900926 Product Name Previous Premarket… | 1990 |
What descends from it? (8)
4 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 35 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K233498 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2023) has gone furthest, with 4 descendants of its own.
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 DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach. The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only. The DALL-MILES…
Read the full statement (153 words)
The DALL-MILES System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment.
The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202016 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202016: Dall-Miles® Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202016
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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