510(k) Report

510(k) · Cleared

Cleared

G/K SFN and STN Locking Nails

K983358510(k) TraditionalCleared Nov 18, 199855-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, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Nov 18, 1998 after a 55-day review. The FDA summary names its predicate without a number. 36 later devices descend from it.

Decided
Nov 18, 1998
Review
55 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2003: 2 descendants cleared2017: 4 descendants cleared2011: 1 descendant cleared2019: 2 descendants cleared2005: 1 descendant cleared2012: 2 descendants cleared2013: 2 descendants cleared2014: 4 descendants cleared2020: 2 descendants cleared2021: 1 descendant cleared2015: 4 descendants cleared2016: 1 descendant cleared2024: 2 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK983358 G/K SFN and STN Locking NailsHowmedica, Inc. · 1998
  2. Descendant · cites it directly · 35 of its ownK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
  3. Descendant · 2 generations on · 30 of its ownK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
  4. Descendant · 2 generations on · 29 of its ownK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
  5. Descendant · 3 generations on · 21 of its ownK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
  6. Descendant · 4 generations on · 19 of its ownK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2001: 12003: 22005: 12011: 12012: 22013: 22014: 42015: 42016: 12017: 42019: 22020: 22021: 12023: 32024: 22025: 12026: 3
2001high 4 (2014) · low 0 (2002)2026

Most influential descendants

Showing 5 of 36 · See all
  • K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · cites it directly35descendants
  • K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · 2 generations on30descendants
  • K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · 2 generations on29descendants
  • K131677Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013 · 3 generations on21descendants
  • K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013 · 4 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983358G/K SFN and STN Locking NailsHowmedica, Inc.1998—
+1K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc.20011
+2K031219Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc.20031
+2K101997Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.20112
+3K131677Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2013—
+4K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200320
200510
201110
201220
201320
201440
201540
201610
201740
201920
202020
202110
202330
202420
202510
202630
FIG. 1 — Lineage of K983358, 1998–2026Source: 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 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? (4)

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
*—Synthes’ Universal Femoral Nail
Named without a submission number
—
*—Synthes’ Unreamed Tibial Nail
Named without a submission number
—
*—Orthofix’s Tibial Nailing System
Named without a submission number
—
*—Orthofix’s Femoral Nailing System
Named without a submission number
—

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K010322Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc.200135

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, K010322 (Orthodyne, Inc., 2001) has gone furthest, with 35 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 G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions.

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, Inc.

36 FDA decisions under this applicant name. See the company

  • K984251Xia Spine SystemHowmedica, Inc. · 1999
  • K984202Howmedica Humeral Intercalary SystemHowmedica, Inc. · 1999
  • K984305Zeta Multizone Locking Nail SystemHowmedica, Inc. · 1999
  • K983885Burr Hole Covers, Craniomaxillofacial PlatesHowmedica, Inc. · 1999
  • K982463Extracranial Radiotherapy SystemHowmedica, Inc. · 1998

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K983358 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983358: G/K SFN and STN Locking Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983358

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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