510(k) · Cleared
Recalled · Class II · 2018Eos Small Bone Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TriMed, Inc. · HRS Plate, Fixation, Bone
Cleared on May 10, 2012 as substantially equivalent to K093676 (TriMed, Inc., 2010) and 6 other predicates after a 227-day review. Its family tree reaches back 5 generations to 1992. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- May 10, 2012
- Review
- 227 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 4
- Predicates
- 7
Its longest line of descent runs back 5 generations to K915818 (1992). 38 ancestors in all, the oldest K792022 (1979). 9 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 4 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 3 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 2 generations backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- 1 generation backK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- This deviceK112794 Eos Small Bone Fixation SystemTriMed, Inc. · 2012
- Descendant · cites it directly · 7 of its ownK153395 OS2-C Compression StapleIn2bones Sas · 2016
- Descendant · 2 generations on · 3 of its ownK163440 Stealth Staple SystemFirst Ray, LLC · 2017
- Descendant · 2 generations on · 2 of its ownK212594 OSSIOfiber® StapleOSSIO, Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK233302 OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK220181 StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K153395OS2-C Compression StapleIn2bones Sas · 2016 · cites it directly7descendants
- K163440Stealth Staple SystemFirst Ray, LLC · 2017 · 2 generations on3descendants
- K212594OSSIOfiber® StapleOSSIO, Ltd. · 2022 · 2 generations on2descendants
- K233302OSSIOfiber® Compression StapleOSSIO, Ltd. · 2023 · 3 generations on1descendant
- K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc. · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −4 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −3 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −2 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| −1 | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| 0 (this device) | K112794 | Eos Small Bone Fixation System | TriMed, Inc. | 2012 | — |
| +1 | K153395 | OS2-C Compression Staple | In2bones Sas | 2016 | — |
| +2 | K163440 | Stealth Staple System | First Ray, LLC | 2017 | — |
| +2 | K212594 | OSSIOfiber® Staple | OSSIO, Ltd. | 2022 | — |
| +3 | K233302 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | 2023 | — |
| +3 | K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (7)
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 |
|---|---|---|---|
| * | K093676 | Omnitech Large, Trimed Compression ScrewSummary page 2…Predicate Device TriMed EOS Small Bone (Manufacturer) Fixation Device K093 676 Omnitech Large Compression Large Cannulated Screws (TriMe… | 2010 |
| * | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities PlatesSummary page 2…Omnitech Large Compression Large Cannulated Screws (TriMed) Compression Screws K050681 Omnitech Compression Screws Cannulated Compression (TriMe… | 2005 |
| * | K991477 | Spin Snap-Off ScrewSummary page 2…Omnitech Compression Screws Cannulated Compression (TriMed) Screws K991477 SPIN Snap-Off Screws Snap-Off Screws (NewDeal)… | 1999 |
| * | K021626 | Hallu PlatesSummary page 2…SPIN Snap-Off Screws Snap-Off Screws (NewDeal) ______________ K02 1626 & Hallu Plates (NewDeal) Bone Plates K050681 EasyLock Osteosyst… | 2002 |
| * | K011716 | The Uni-Clip Staple | 2001 |
| * | K070031 | Memometal Memory StaplesSummary page 2…(TriMed) _____________ KOI 11716, lini-Clip Staple (Newneal), Staples & Pins K07003 1, & Memory Staple (MemoMetal K070033 Technologies), &… | 2007 |
| * | K070033 | Memometal Varisation, Models AV26-08, AV26-10, AV90-08 and AV90-10Summary page 2…KOI 11716, lini-Clip Staple (Newneal), Staples & Pins K07003 1, & Memory Staple (MemoMetal K070033 Technologies), & Varisation Staples ____… | 2007 |
What descends from it? (9)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2018 | Class II | Z-2265-2018 | Process design | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of… |
| Apr 13, 2018 | Class II | Z-2264-2018 | Process design | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of… |
| Apr 13, 2018 | Class II | Z-2263-2018 | Process design | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of… |
| Apr 13, 2018 | Class II | Z-2262-2018 | Process design | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 10 of the 38 ancestors have a recall of any class.
- Of its descendants, K153395 (In2bones Sas, 2016) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K093676.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 components of the TriMed EOS Small Bone Fixation System are indicated for use in osteosynthesis, osteotomy, and arthrodesis of the following areas of the body:
Large Cannulated Compression Screws - bones in the foot
Cannulated Compression Screws - small bones in the hand and foot
Snap-Off Screws - small bones in the foot
Bone Plates - first metatarso-phalangeal joint
Staples & Pins - small bones in the hand and foot
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112794: Eos Small Bone Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112794
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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