510(k) Report

510(k) · Cleared

Cleared

Compression Hip Screw System

K781762510(k) TraditionalCleared Dec 20, 197865-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

Howmedica Corp. · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Cleared on Dec 20, 1978 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided
Dec 20, 1978
Review
65 days
Class
Class II
Product code
KTW
Recalls
None
Predicates
0

8 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2012: 1 descendant cleared1997: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2004: 1 descendant cleared2011: 1 descendant cleared2023: 1 descendant cleared19801990200020102020
  1. This deviceK781762 Compression Hip Screw SystemHowmedica Corp. · 1978
  2. Descendant · cites it directly · 3 of its ownK984331 Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
  3. Descendant · cites it directly · 2 of its ownK120360 Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
  4. Descendant · 2 generations on · 2 of its ownK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004
  5. Descendant · 2 generations on · 1 of its ownK202764 Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020
  6. Descendant · 3 generations on · 1 of its ownK111352 Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1997: 11999: 12004: 12011: 12012: 12020: 12021: 12023: 1
1997high 1 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 8 · See all
  • K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999 · cites it directly3descendants
  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly2descendants
  • K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004 · 2 generations on2descendants
  • K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020 · 2 generations on1descendant
  • K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K781762Compression Hip Screw SystemHowmedica Corp.1978—
+1K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc.1999—
+1K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited2012—
+2K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)2004—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.2020—
+3K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200410
201110
201210
202010
202110
202310
FIG. 1 — Lineage of K781762, 1978–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc.19993
K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122
K971993Odi Compression Hip Screw SystemOrthopaedic Designs, Inc.19970

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?

  • Of its descendants, K984331 (Orthopedic Designs, Inc., 1999) has gone furthest, with 3 descendants of its own.

How does its category compare?

All KTW devices

KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTW

1in 2019

2008: 22012: 12016: 12017: 22019: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTW

Too few KTW 510(k)s in any year since 2007 to give a median.

Recalls per year · KTW

57in 2010

2010: 57
2007high 57 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KTW

96in 2025

2007: 32008: 102009: 22010: 262011: 212012: 702013: 702014: 622015: 262016: 412017: 272018: 242019: 112020: 602021: 252022: 502023: 302024: 1232025: 96
2007high 123 (2024) · low 2 (2009)2025

MAUDE reports naming product code KTW, 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
20070—03
20082—010
20090—02
20100—5726
20110—021
20121—070
20130—070
20140—062
20150—026
20161—041
20172—027
20180—024
20191—011
20200—060
20210—025
20220—050
20230—030
20240—0123
20250—096
20260—0—
Cite this page

510(k) Report. “K781762: Compression Hip Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781762

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026