510(k) Report

510(k) · Cleared

Cleared

Gamma 3 Lag Screw

K020677510(k) SpecialCleared Mar 29, 200228-day reviewClass II21 CFR 888.3020

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

Howmedica Osteonics Corp. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Mar 29, 2002 after a 28-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Mar 29, 2002
Review
28 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2018: 3 descendants cleared2023: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK020677 Gamma 3 Lag ScrewHowmedica Osteonics Corp. · 2002
  2. Descendant · cites it directly · 5 of its ownK103400 Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt)…Stryker Corporation · 2011
  3. Descendant · 2 generations on · 2 of its ownK173946 ADAPT for Gamma3Stryker GmbH · 2018
  4. Descendant · 2 generations on · 1 of its ownK182359 HipCheckStryker Corp. · 2018
  5. Descendant · 3 generations on · 1 of its ownK181848 ADAPT for Gamma3, Gamma3Stryker GmbH · 2018
  6. Descendant · 3 generations on · 0 of its ownK230045 HipCheckStryker Corp. · 2023

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2011: 12018: 32020: 12023: 1
2011high 3 (2018) · low 0 (2012)2026

Most influential descendants

Showing 5 of 6 · See all
  • K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation · 2011 · cites it directly5descendants
  • K173946ADAPT for Gamma3Stryker GmbH · 2018 · 2 generations on2descendants
  • K182359HipCheckStryker Corp. · 2018 · 2 generations on1descendant
  • K181848ADAPT for Gamma3, Gamma3Stryker GmbH · 2018 · 3 generations on1descendant
  • K230045HipCheckStryker Corp. · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K020677Gamma 3 Lag ScrewHowmedica Osteonics Corp.2002—
+1K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation2011—
+2K173946ADAPT for Gamma3Stryker GmbH2018—
+2K182359HipCheckStryker Corp.2018—
+3K181848ADAPT for Gamma3, Gamma3Stryker GmbH2018—
+3K230045HipCheckStryker Corp.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201830
202010
202310
FIG. 1 — Lineage of K020677, 2002–2023Source: 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), 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 HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 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? (1)

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
*—Dyax Nail Lag Screw
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K103400Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipStryker Corporation20115

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, K103400 (Stryker Corporation, 2011) has gone furthest, with 5 descendants of its own.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The Gamma 3 Lag Screw is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail. Intended Use for the Long Length Dyax Nail The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft…

Read the full statement (116 words)

The Gamma 3 Lag Screw is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail.

Intended Use for the Long Length Dyax Nail

The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma, non-union, mal-union, pathological fractures, and impending pathological fractures.

Intended Use for the Trochanteric Dyax Nail

The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Howmedica Osteonics Corp.

319 FDA decisions under this applicant name. See the company

  • P000013/S027Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® SystemHowmedica Osteonics Corp. · 2025
  • P000013/S026Trident Acetabular System: Trident Alumina InsertsHowmedica Osteonics Corp. · 2025
  • P000013/S025Trident® Acetabular SystemHowmedica Osteonics Corp. · 2024
  • P000013/S024Trident (R), ABC (R)Howmedica Osteonics Corp. · 2024
  • P000013/S021Trident Ceramic SystemHowmedica Osteonics Corp. · 2023

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The HSB category page

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https://510kreport.com/device/K020677 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020677: Gamma 3 Lag Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020677

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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