510(k) · Cleared
ClearedOmnitech System & Easy Lock Osteosystem with Xtremities Plates
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 Jul 27, 2005 as substantially equivalent to K991964 (Groupe Lepine, 1999) and 5 other predicates after a 133-day review. Its family tree reaches back 4 generations to 1992. 92 later devices descend from it.
- Decided
- Jul 27, 2005
- Review
- 133 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to K915818 (1992). 18 ancestors in all, the oldest K792022 (1979). 92 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 3 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 2 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 1 generation backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- This deviceK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- Descendant · cites it directly · 68 of its ownK092670 Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009
- Descendant · cites it directly · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
- Descendant · 2 generations on · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
- Descendant · 2 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009 · cites it directly68descendants
- K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly58descendants
- K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · 2 generations on28descendants
- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 2 generations on24descendants
- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −3 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −2 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −1 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| 0 (this device) | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| +1 | K092670 | Biodrive Micro Screw System | Ebi,Llc D/B/A Biomet Trauma | 2009 | — |
| +1 | K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | Ortho Solutions Limited | 2012 | 1 |
| +2 | K141784 | Ortho Solutions Ultos Plating System | Ortho Solutions Limited | 2014 | 2 |
| +2 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| +2 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 10 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 14 | 0 |
| 2024 | 10 | 0 |
| 2025 | 8 | 0 |
| 2026 | 11 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991964 | Eis Threaded Screw Fracture FixationSummary page 2…osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis. Substantial Equivalence: Omnitech K991964 - Lepine ElS Threaded Screws for Metatarsal Fixation K792022 - Zimmer Herbert Bone Screw K021626 - Newdeal Hallu Pl… | 1999 |
| * | K792022 | Herbert Bone ScrewSummary page 2…the fixation of osteotomies or arthrodesis. Substantial Equivalence: Omnitech K991964 - Lepine ElS Threaded Screws for Metatarsal Fixation K792022 - Zimmer Herbert Bone Screw K021626 - Newdeal Hallu Plates K001941 - Synthes Modular Foot System K961941 - H… | 1979 |
| * | K021626 | Hallu PlatesSummary page 2…odesis. Substantial Equivalence: Omnitech K991964 - Lepine ElS Threaded Screws for Metatarsal Fixation K792022 - Zimmer Herbert Bone Screw K021626 - Newdeal Hallu Plates K001941 - Synthes Modular Foot System K961941 - Howmedica Profyle Hand & Small Fragment Syst… | 2002 |
| * | K001941 | Synthes Modular Foot SystemSummary page 2…Omnitech K991964 - Lepine ElS Threaded Screws for Metatarsal Fixation K792022 - Zimmer Herbert Bone Screw K021626 - Newdeal Hallu Plates K001941 - Synthes Modular Foot System K961941 - Howmedica Profyle Hand & Small Fragment System Easy Lock K021626… | 2000 |
| Kept off the family tree | K961941 | FDA’s K961941 is Liquichek Immunoassay Plus Control Catalog NO. 360,361,362,363 Our reading of the summary gave K961941, FDA’s number for Liquichek Immunoassay Plus Control Catalog NO.… (Bio-Rad). Its FDA name has none of the distinctive words the summary uses for the device it names, “Howmedica Profyle Hand & Small Fragment System”. Kept off the family tree. Summary page 2…eaded Screws for Metatarsal Fixation K792022 - Zimmer Herbert Bone Screw K021626 - Newdeal Hallu Plates K001941 - Synthes Modular Foot System K961941 - Howmedica Profyle Hand & Small Fragment System Easy Lock K021626 - Newdeal Hallu Plates K961941 - Howme… | 1996 |
| * | K991873 | Kmi Wrist Fusion SystemSummary page 2…Easy Lock K021626 - Newdeal Hallu Plates K961941 - Howmedica Profyle Hand & Small Fragment System (Now Stryker Leibinger) K991873 -KMI Wrist Fusion System K021321 - Acumed Wrist Fusion Plate KelayAfnderson Regulatory Affairs Specialist === Page 3… | 1999 |
| * | K021321 | Wrist Fusion PlateSummary page 2…eal Hallu Plates K961941 - Howmedica Profyle Hand & Small Fragment System (Now Stryker Leibinger) K991873 -KMI Wrist Fusion System K021321 - Acumed Wrist Fusion Plate KelayAfnderson Regulatory Affairs Specialist DEPARTMENT OF HEALTH & HUMAN SERV… | 2002 |
What descends from it? (92)
See all 928 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092670 | Biodrive Micro Screw System | 2009 | 68 |
| K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | 2012 | 58 |
| K112794 | Eos Small Bone Fixation System | 2012 | 9 |
| K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS… | 2020 | 6 |
| K243943 | TriMed® Compression Screws | 2025 | 2 |
| K252061 | Distal Xtremities System | 2025 | 0 |
| K250948 | TriMed Fusion Cup System | 2025 | 0 |
| K111266 | Easylock Osteosystem | 2011 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 18 ancestors have a recall of any class.
- Of its descendants, K092670 (Ebi,Llc D/B/A Biomet Trauma, 2009) has gone furthest, with 68 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 Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot.
The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050681
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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