510(k) Report

510(k) · Cleared

Cleared

True/Flex Clavicle Rods

K934148510(k) TraditionalCleared Feb 22, 1994181-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 Feb 22, 1994 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 22, 1994
Review
181 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK934148 True/Flex Clavicle RodsApplied Osteo Systems, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK083144 Acumed Clavicle Screw SystemAcumed, LLC · 2009
  3. Descendant · 2 generations on · 0 of its ownK242896 Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K083144Acumed Clavicle Screw SystemAcumed, LLC · 2009 · cites it directly1descendant
  • K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934148True/Flex Clavicle RodsApplied Osteo Systems, Inc.1994—
+1K083144Acumed Clavicle Screw SystemAcumed, LLC2009—
+2K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
202510
FIG. 1 — Lineage of K934148, 1994–2025Source: 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
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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? (2)

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

NumberDeviceApplicantDecidedDescendants
K083144Acumed Clavicle Screw SystemAcumed, LLC20091

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, K083144 (Acumed, LLC, 2009) has gone furthest, with 1 descendant 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

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https://510kreport.com/device/K934148 · printed Nov 5, 2026

Cite this page

510(k) Report. “K934148: True/Flex Clavicle Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K934148

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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