510(k) · Cleared
ClearedMini-Fixator for Colles Fractures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HRS Plate, Fixation, Bone
Cleared on Oct 13, 1998 after a 48-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Oct 13, 1998
- Review
- 48 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK982982 Mini-Fixator for Colles FracturesBiomet, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK984498 Synthes (Usa) Articulating Distal Radius (Adrf) SystemSynthes (Usa) · 1999
- Descendant · 2 generations on · 3 of its ownK012294 Wristore FixatorMillennium Medical Technologies, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK042761 Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK101338 Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011
- Descendant · 4 generations on · 0 of its ownK052498 Fragment Specific FixatorDavid J. Slutsky MD · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K984498Synthes (Usa) Articulating Distal Radius (Adrf) SystemSynthes (Usa) · 1999 · cites it directly5descendants
- K012294Wristore FixatorMillennium Medical Technologies, Inc. · 2002 · 2 generations on3descendants
- K042761Wristore Distal Radius Fracture Fixator, 4600 SeriesZimmer, Inc. · 2004 · 3 generations on1descendant
- K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V · 2011 · 3 generations on0descendants
- K052498Fragment Specific FixatorDavid J. Slutsky MD · 2005 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982982 | Mini-Fixator for Colles Fractures | Biomet, Inc. | 1998 | — |
| +1 | K984498 | Synthes (Usa) Articulating Distal Radius (Adrf) System | Synthes (Usa) | 1999 | — |
| +2 | K012294 | Wristore Fixator | Millennium Medical Technologies, Inc. | 2002 | — |
| +3 | K042761 | Wristore Distal Radius Fracture Fixator, 4600 Series | Zimmer, Inc. | 2004 | — |
| +3 | K101338 | Newfix External Fixation System | Technologia Y Diseno Industrial, S.A DE C.V | 2011 | — |
| +4 | K052498 | Fragment Specific Fixator | David J. Slutsky MD | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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? (5)
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 |
|---|---|---|---|
| * | — | ACE DePuy device Named without a submission number | |
| * | — | Trend Medical device Named without a submission number | |
| * | — | Zimmer device Named without a submission number | |
| * | — | OrthoFrame device Named without a submission number | |
| * | — | SE device Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984498 | Synthes (Usa) Articulating Distal Radius (Adrf) System | 1999 | 5 |
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, K984498 (Synthes (Usa), 1999) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Mini-Fixator for Colles Fractures is intended for use in the repair of Colles fractures. The device is intended for single use only and is external with internal pins.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982982 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982982: Mini-Fixator for Colles Fractures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982982
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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