510(k) Report

510(k) · Cleared

Cleared

True/Flex Humerus, Ulna and Radius Intramedullary

K902264510(k) TraditionalCleared Jul 12, 199052-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

Applied Osteo Systems, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jul 12, 1990 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it.

Decided
Jul 12, 1990
Review
52 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 1 descendant cleared1996: 1 descendant cleared2007: 2 descendants cleared2003: 3 descendants cleared2011: 3 descendants cleared2010: 2 descendants cleared2002: 1 descendant cleared2004: 4 descendants cleared2015: 2 descendants cleared2013: 4 descendants cleared2016: 3 descendants cleared2012: 1 descendant cleared2017: 3 descendants cleared2020: 5 descendants cleared2018: 2 descendants cleared2019: 3 descendants cleared2006: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared2009: 1 descendant cleared2026: 2 descendants cleared2025: 2 descendants cleared2024: 2 descendants cleared2014: 2 descendants cleared2021: 2 descendants cleared1990200020102020
  1. This deviceK902264 True/Flex Humerus, Ulna and Radius IntramedullaryApplied Osteo Systems, Inc. · 1990
  2. Descendant · cites it directly · 54 of its ownK013449 Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001
  3. Descendant · 2 generations on · 53 of its ownK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
  4. Descendant · 2 generations on · 32 of its ownK032588 Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003
  5. Descendant · 2 generations on · 32 of its ownK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003
  6. Descendant · 2 generations on · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

1996: 12001: 12002: 12003: 32004: 42006: 12007: 22009: 12010: 22011: 32012: 12013: 42014: 22015: 22016: 32017: 32018: 22019: 32020: 52021: 22022: 22023: 22024: 22025: 22026: 2
1996high 5 (2020) · low 0 (1997)2026

Most influential descendants

Showing 5 of 56 · See all
  • K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · cites it directly54descendants
  • K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd. · 2002 · 2 generations on53descendants
  • K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003 · 2 generations on32descendants
  • K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003 · 2 generations on32descendants
  • K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · 2 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902264True/Flex Humerus, Ulna and Radius IntramedullaryApplied Osteo Systems, Inc.1990—
+1K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.2001—
+2K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF…Disco-O-Tech Medical Technologies, Ltd.2002—
+2K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd.2003—
+2K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd.2003—
+2K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200110
200210
200330
200440
200610
200720
200910
201020
201130
201210
201340
201420
201520
201630
201730
201820
201930
202050
202120
202220
202320
202420
202520
202620
FIG. 1 — Lineage of K902264, 1990–2026Source: 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), 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?

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

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K013449Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd.200154
K071679Metafix and Fixion FA Intramedullary Nailing SystemsDisc-O-Tech Medical Technologies, Ltd.20070
K964243Humerus WiresCompagnie Financiere & Medicale (Cf&M)19960

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, K013449 (Disc-O-Tech Medical Technologies, Ltd., 2001) has gone furthest, with 54 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—

More from Applied Osteo Systems, Inc.

15 FDA decisions under this applicant name. See the company

  • K935383Femrod and Femrod Recon InsertApplied Osteo Systems, Inc. · 1995
  • K933995True/Flextm Femur Rods, Caps, Screws and InstrumentationApplied Osteo Systems, Inc. · 1995
  • K944501True/Flex Intramedullary Rod End-CapApplied Osteo Systems, Inc. · 1994
  • K941048True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 19941 recall
  • K943160Interference ScrewApplied Osteo Systems, Inc. · 1994

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/K902264 · printed Nov 5, 2026

Cite this page

510(k) Report. “K902264: True/Flex Humerus, Ulna and Radius Intramedullary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K902264

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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