510(k) · Cleared
ClearedAcumed Small Fragment Base Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumed, LLC · HRS Plate, Fixation, Bone
Cleared on Jan 23, 2015 as substantially equivalent to K063049 (Synthes (Usa), 2006) and 3 other predicates after a 58-day review. Its family tree reaches back 2 generations to 2000. 18 later devices descend from it.
- Decided
- Jan 23, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K000684 (2000). 5 ancestors in all, the oldest K963192 (1996). 18 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 1 generation backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- This deviceK143394 Acumed Small Fragment Base SetAcumed, LLC · 2015
- Descendant · cites it directly · 15 of its ownK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- Descendant · 2 generations on · 14 of its ownK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- Descendant · 3 generations on · 6 of its ownK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- Descendant · 3 generations on · 4 of its ownK212487 CoLink Vallux Plating SystemIn2bones USA, LLC · 2021
- Descendant · 4 generations on · 3 of its ownK211650 The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015 · cites it directly15descendants
- K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018 · 2 generations on14descendants
- K191535CoLink® Mini Plating SystemIn2bones USA, LLC · 2019 · 3 generations on6descendants
- K212487CoLink Vallux Plating SystemIn2bones USA, LLC · 2021 · 3 generations on4descendants
- K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −1 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| 0 (this device) | K143394 | Acumed Small Fragment Base Set | Acumed, LLC | 2015 | — |
| +1 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| +2 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
| +3 | K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019 | — |
| +3 | K212487 | CoLink Vallux Plating System | In2bones USA, LLC | 2021 | — |
| +4 | K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 4…ories Class: Class II Product Code: HRS, HWC Legally Marketed Predicate Device(s) The Synthes (USA) Modular Mini Fragment LCP System cleared in 2006 (K063049), Synthes (USA) 3.5mm LCP Hook Plate cleared in 2008 (K082072), Synthes One-Third Tubular DCL Plate cleared in 2001 (K011335), an… | 2006 |
| * | K082072 | Synthes (Usa) 3.5MM LCP Hook PlateSummary page 4…C Legally Marketed Predicate Device(s) The Synthes (USA) Modular Mini Fragment LCP System cleared in 2006 (K063049), Synthes (USA) 3.5mm LCP Hook Plate cleared in 2008 (K082072), Synthes One-Third Tubular DCL Plate cleared in 2001 (K011335), and Synthes Sterile 3.5mm and 4.0mm Cannulated Screws cleared in… | 2008 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 4…ar Mini Fragment LCP System cleared in 2006 (K063049), Synthes (USA) 3.5mm LCP Hook Plate cleared in 2008 (K082072), Synthes One-Third Tubular DCL Plate cleared in 2001 (K011335), and Synthes Sterile 3.5mm and 4.0mm Cannulated Screws cleared in 1996 (K963192) serve as predicate devices. Device Description… | 2001 |
| * | K963192 | Synthes Sterile 3.5 MM and 4.0 MM Cannulated ScrewsSummary page 4…ok Plate cleared in 2008 (K082072), Synthes One-Third Tubular DCL Plate cleared in 2001 (K011335), and Synthes Sterile 3.5mm and 4.0mm Cannulated Screws cleared in 1996 (K963192) serve as predicate devices. Device Description The Acumed Small Fragment Base Set contains orthopedic plates and screws indicat… | 1996 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 13.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K151886 (Acumed, LLC, 2015) has gone furthest, with 15 descendants of its own.
- 39 other devices also cite its predicate K063049.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia, and fibula. Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143394: Acumed Small Fragment Base Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143394
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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