510(k) Report

510(k) · Cleared

Cleared

Speed Arc

K133270510(k) TraditionalCleared Apr 17, 2014176-day reviewClass II21 CFR 888.3030

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

Biomedical Enterprises, Inc. · JDR Staple, Fixation, Bone

Cleared on Apr 17, 2014 after a 176-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.

Decided
Apr 17, 2014
Review
176 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
0

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

Descendants, by year cleared 2014: 1 descendant cleared2022: 2 descendants cleared2020: 2 descendants cleared2019: 1 descendant cleared2024: 1 descendant cleared2018: 2 descendants cleared2015: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants cleared2025: 1 descendant cleared2010201520202025
  1. This deviceK133270 Speed ArcBiomedical Enterprises, Inc. · 2014
  2. Descendant · cites it directly · 13 of its ownK142292 Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · Recalled
  3. Descendant · 2 generations on · 3 of its ownK193305 DynaClip Bone StapleMedShape, Inc. · 2020
  4. Descendant · 3 generations on · 2 of its ownK220812 DynaClip® Bone StapleMedShape, Inc. · 2022
  5. Descendant · 3 generations on · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
  6. Descendant · 2 generations on · 1 of its ownK203180 Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2020

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12018: 22019: 12020: 22022: 22023: 12024: 12025: 12026: 2
2014high 2 (2018) · low 0 (2016)2026

Most influential descendants

Showing 5 of 14 · See all
  • K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · cites it directly13descendants
  • K193305DynaClip Bone StapleMedShape, Inc. · 2020 · 2 generations on3descendants
  • K220812DynaClip® Bone StapleMedShape, Inc. · 2022 · 3 generations on2descendants
  • K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · 3 generations on1descendant
  • K203180Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K133270Speed ArcBiomedical Enterprises, Inc.2014—
+1K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc.20143
+2K193305DynaClip Bone StapleMedShape, Inc.2020—
+3K220812DynaClip® Bone StapleMedShape, Inc.2022—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte…MedShape, Inc.2026—
+2K203180Arthrex DynaNite Nitinol StaplesArthrex, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201820
201910
202020
202220
202310
202410
202510
202620
FIG. 1 — Lineage of K133270, 2014–2026Source: 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 JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc.201413

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, K142292 (Biomedical Enterprises, Inc., 2014) has gone furthest, with 13 descendants of its own.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

More from Biomedical Enterprises, Inc.

10 FDA decisions under this applicant name. See the company

  • K153573ConvergeBiomedical Enterprises, Inc. · 2016
  • K150125Elite Nitinol Fixation SystemBiomedical Enterprises, Inc. · 2015
  • K143023Nitinol Compression Plating SystemBiomedical Enterprises, Inc. · 2015
  • K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 20143 recalls
  • K133520Hammerlock 2Biomedical Enterprises, Inc. · 2014

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K133270 · printed Nov 4, 2026

Cite this page

510(k) Report. “K133270: Speed Arc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133270

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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