510(k) Report

510(k) · Cleared

Cleared

Dall-Miles System

K070170510(k) TraditionalCleared Mar 2, 200743-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Orthopaedics · HRS Plate, Fixation, Bone

Cleared on Mar 2, 2007 as substantially equivalent to K993510 (Biomet, Inc., 1999) and 1 other predicate after a 43-day review. Its family tree reaches back 2 generations to 1987. 9 later devices descend from it.

Decided
Mar 2, 2007
Review
43 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K872224 (1987). 4 ancestors in all. 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1990: 1 other ancestor2020: 1 descendant cleared2024: 2 descendants cleared2023: 2 descendants cleared2026: 2 descendants cleared2025: 2 descendants clearedK872224 · Modified Trochanter Cable Grip System · Howmedica Corp. · 1987 · recalledK962162 · Dall-Miles Trochanter Cable Supergrip · Howmedica Corp. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 4 descendants K962162 · Dall-Miles Trochanter Cable Supergrip · Howmedica Corp. · 1996K872224 · Modified Trochanter Cable Grip System · Howmedica Corp. · 1987 · recalled0
  1. Root · 2 generations backK872224 Modified Trochanter Cable Grip SystemHowmedica Corp. · 1987 · Recalled
  2. 1 generation backK962162 Dall-Miles Trochanter Cable SupergripHowmedica Corp. · 1996
  3. This deviceK070170 Dall-Miles SystemStryker Orthopaedics · 2007
  4. Descendant · cites it directly · 8 of its ownK202016 Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
  5. Descendant · 2 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
  6. Descendant · 3 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
  7. Descendant · 2 generations on · 1 of its ownK231257 Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023
  8. Descendant · 3 generations on · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2020: 12023: 22024: 22025: 22026: 2
2020high 2 (2023) · low 0 (2021)2026

Most influential descendants

Showing 5 of 9 · See all
  • 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
  • K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 3 generations on2descendants
  • K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH · 2023 · 2 generations on1descendant
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K872224Modified Trochanter Cable Grip SystemHowmedica Corp.19872
−1K962162Dall-Miles Trochanter Cable SupergripHowmedica Corp.1996—
0 (this device)K070170Dall-Miles SystemStryker Orthopaedics2007—
+1K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics2020—
+2K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023—
+3K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025—
+2K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH2023—
+3K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20262

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202320
202420
202520
202620
FIG. 1 — Lineage of K070170, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K993510Modified BMP Trochanteric Plates
Summary page 2
…Substantial Equivalence: The Dall-Miles® Trochanteric Grips and Grip Plates are substantially equivalent to the Modified BMPTM Trochanteric Plates, cleared by Biomet (K993510) and the Dall-Miles® Trochanter Cable Super Grip, cleared by Howmedica Osteonics (K962162).…
Biomet, Inc.1999—
*K962162Dall-Miles Trochanter Cable Supergrip
Summary page 2
…tially equivalent to the Modified BMPTM Trochanteric Plates, cleared by Biomet (K993510) and the Dall-Miles® Trochanter Cable Super Grip, cleared by Howmedica Osteonics (K962162). 4 DE…
Howmedica Corp.1996—

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202016Dall-Miles® Cable SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20208

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 20 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K202016 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2020) has gone furthest, with 8 descendants of its own.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

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® 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.

More from Stryker Orthopaedics

24 FDA decisions under this applicant name. See the company

  • K211703Insignia Hip StemStryker Orthopaedics · 2021
  • K191414EXETER Centralizer, EXETER 2.5mm PlugStryker Orthopaedics · 2019
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K173849Triathlon Total Knee SystemStryker Orthopaedics · 20183 recalls
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 20171 recall

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
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https://510kreport.com/device/K070170 · printed Nov 4, 2026

Cite this page

510(k) Report. “K070170: Dall-Miles System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070170

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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