510(k) · Cleared
ClearedKmi Wrist Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetikos Medical, Inc. · HRS Plate, Fixation, Bone
Cleared on Feb 18, 1999 as substantially equivalent to K915818 (Synthes (Usa), 1992) after a 37-day review. Its family tree reaches back 1 generation to 1992. 127 later devices descend from it.
- Decided
- Feb 18, 1999
- Review
- 37 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915818 (1992). 127 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- This deviceK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- Descendant · cites it directly · 117 of its ownK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- Descendant · 2 generations on · 113 of its ownK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- Descendant · 2 generations on · 92 of its ownK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- Descendant · 3 generations on · 68 of its ownK092670 Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009
- Descendant · 3 generations on · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 127 · See all- K991873Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999 · cites it directly117descendants
- K021321Wrist Fusion PlateAcu Med, Inc. · 2002 · 2 generations on113descendants
- K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005 · 2 generations on92descendants
- K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009 · 3 generations on68descendants
- K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · 3 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| 0 (this device) | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| +1 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| +2 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| +2 | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| +3 | K092670 | Biodrive Micro Screw System | Ebi,Llc D/B/A Biomet Trauma | 2009 | — |
| +3 | K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | Ortho Solutions Limited | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 12 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 19 | 0 |
| 2024 | 14 | 0 |
| 2025 | 9 | 0 |
| 2026 | 14 | 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? (2)
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 |
|---|---|---|---|
| * | K915818 | Synthes (R) Titanium Small Reconstruction PlateSummary page 1…Wrist Fusion System Common/Usual Name: Plate, fixation, bone Classification Name: Plate, fixation, bone Predicate Device: Synthes Titanium Small Reconstruction Plate-K915818, and Synthes 3.5 mm Dynamic Compression Plate-a Preamend- ment device Description of Device: The KMI Wrist Fusion System consis… | 1992 |
| * | — | Synthes 3.5 mm Dynamic Compression Plate Named without a submission number |
What descends from it? (127)
See all 1273 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?
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 KMI Wrist Fusion System is indicated for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, or rtheumatoid arthritis.
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/K990094 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990094: Kmi Wrist Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990094
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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