510(k) · Cleared
ClearedCanMINI Hand and Foot System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canwell Medical Co., Ltd. · HRS Plate, Fixation, Bone
Cleared on Apr 24, 2025 as substantially equivalent to K090047 (Synthes (Usa), 2009) and 7 other predicates after a 210-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Apr 24, 2025
- Review
- 210 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 9 generations to K962616 (1996). 51 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 1 generation backK092015 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2009 · Recalled
- This deviceK242973 CanMINI Hand and Foot SystemCanwell Medical Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 1 generation backK092015 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2009 · Recalled
- This deviceK242973 CanMINI Hand and Foot SystemCanwell Medical Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −2 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −1 | K092015 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2009 | 1 |
| 0 (this device) | K242973 | CanMINI Hand and Foot System | Canwell Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 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? (8)
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 |
|---|---|---|---|
| * | K090047 | Synthes (Usa) 1.5MM Mini Fragment LCP SystemSummary page 5…ommon name: / Classification: Class II, 21 CFR 888.3030 Product Code: HRS Premarket Notification: K090047 Manufacturer: Synthes (USA) IV.2. Additional Predicate Devices Trade name: Double… | 2009 |
| * | K130108 | Double Engine Bone Plate and Screw SystemsSummary page 6…510(k) summary Classification: Class II, 21 CFR 888.3030 Product Code: HRS, HWC Premarket Notification: K130108 Manufacturer: XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD Trade name: Single/multiple Compo… | 2013 |
| * | K033639 | Acumed Lower Extremity Congruent Plate SystemSummary page 6…ories Common name: Plate, Fixation, Bone Classification: Class II, 21 CFR 888.3030 Product Code: HRS Premarket Notification: K033639 Manufacturer: Acumed LLC Trade name: Synthes (USA) Modular Mini Fragment LCP System Common name:… | 2004 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 6…Mini Fragment LCP System Common name: / Classification: Class II, 21 CFR 888.3030 Product Code: HRS Premarket Notification: K063049 Manufacturer: Synthes (USA) Trade name: PERI-LOC Periarticular Locked Plating System Common name… | 2006 |
| * | K092015 | Peri-Loc Periarticular Locked Plating SystemSummary page 6…Common name: Bone Plates and Bone Screws Classification: Class II, 21 CFR 888.3030 Product Code: HRS Premarket Notification: K092015 Manufacturer: Smith & Nephew, Inc. Trade name: Arthrex Mini Comprehensive Fixation System - 2.0mm… | 2009 |
| * | K191344 | Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm ModuleSummary page 6…d metallic bone fixation fastener Classification: Class II, 21 CFR 888.3030, 21 CFR 888.3040 Product Code: HRS; HWC Premarket Notification: K191344 Manufacturer: Arthrex Inc. Trade name: ACUTRACT CANWELL MEDICAL CO., LTD.… | 2019 |
| * | K930834 | AcutractSummary page 7…ommon name: / Classification: Class II, 21 CFR 888.3040 Product Code: HWC Premarket Notification: K930834 Manufacturer: ACUMED, INC. Trade name: Synthes (USA) / 3.5 nun and 4.5 nun Locking… | 1993 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 7…name: / Premarket Notification: Class II, 21 CFR 888.3030 Product Code: HRS; HWC Premarket Notification: K082807 Manufacturer: Synthes (USA) V. Device Description Summary The CanMINI Hand and Foot System, manufactured by… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 12 of the 51 ancestors have a recall of any class.
- 17 other devices also cite its predicate K090047.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 CanMINI Hand and Foot System is indicated for fixation of small bones and small bone fragments in the hand and foot. The devices are intended to be single-use and sterilized before use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242973 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242973: CanMINI Hand and Foot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242973
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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