510(k) Report

510(k) · Cleared

Cleared

Osteo IC Femoral and Tibial Nails in Titanium Alloy

K992063510(k) TraditionalCleared Sep 3, 199977-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 Sep 3, 1999 after a 77-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.

Decided
Sep 3, 1999
Review
77 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared2002: 1 descendant cleared2014: 2 descendants cleared2017: 2 descendants cleared2026: 2 descendants cleared2023: 1 descendant cleared2019: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK992063 Osteo IC Femoral and Tibial Nails in Titanium AlloyHowmedica Osteonics Corp. · 1999
  2. Descendant · cites it directly · 12 of its ownK011622 Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade…Howmedica Osteonics Corp. · 2001
  3. Descendant · 2 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
  4. Descendant · 3 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
  5. Descendant · 4 generations on · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
  6. Descendant · 3 generations on · 2 of its ownK141228 Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12014: 22017: 22019: 22020: 12023: 12025: 12026: 2
2001high 2 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 13 · See all
  • K011622Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2…Howmedica Osteonics Corp. · 2001 · cites it directly12descendants
  • K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 2 generations on10descendants
  • K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 3 generations on3descendants
  • K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · 4 generations on2descendants
  • K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992063Osteo IC Femoral and Tibial Nails in Titanium AlloyHowmedica Osteonics Corp.1999—
+1K011622Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails…Howmedica Osteonics Corp.2001—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral…I.T.S. GmbH2014—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation2017—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation2019—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
201420
201720
201920
202010
202310
202510
202620
FIG. 1 — Lineage of K992063, 1999–2026Source: 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? (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
*—Osteo IC Femoral and Tibial Nails in Stainless Steel
Named without a submission number
—
*—Howmedica Alta Femoral and Tibial Rod System in Titanium Alloy
Named without a submission number
—

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K011622Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2…Howmedica Osteonics Corp.200112

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, K011622 (Howmedica Osteonics Corp., 2001) has gone furthest, with 12 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 indications for the use of the Osteo IC Femoral and Tibial Nails in Titanium Alloy are as follows:

Closed and open femoral and tibial shaft fractures

Pseudarthrosis and correction osteotomies in the shaft area

Pathological fractures and tumor resections of the shaft area

Change of procedure following external fixation.

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

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/K992063 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992063: Osteo IC Femoral and Tibial Nails in Titanium Alloy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992063

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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