510(k) · Cleared
ClearedOmnitech Large, Trimed Compression Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TriMed, Inc. · HWC Screw, Fixation, Bone
Cleared on Mar 17, 2010 as substantially equivalent to K993106 (Smith & Nephew, Inc., 1999) and 3 other predicates after a 110-day review. Its family tree reaches back 3 generations to 1990. 13 later devices descend from it.
- Decided
- Mar 17, 2010
- Review
- 110 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K903810 (1990). 8 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 2 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 1 generation backK060736 Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · Recalled
- This deviceK093676 Omnitech Large, Trimed Compression ScrewTriMed, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK112794 Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 7 of its ownK153395 OS2-C Compression StapleIn2bones Sas · 2016
- Descendant · 3 generations on · 3 of its ownK163440 Stealth Staple SystemFirst Ray, LLC · 2017
- Descendant · cites it directly · 2 of its ownK243943 TriMed® Compression ScrewsTriMed, Inc. · 2025
- Descendant · 3 generations on · 2 of its ownK212594 OSSIOfiber® StapleOSSIO, Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K112794Eos Small Bone Fixation SystemTriMed, Inc. · 2012 · cites it directly9descendants
- K153395OS2-C Compression StapleIn2bones Sas · 2016 · 2 generations on7descendants
- K163440Stealth Staple SystemFirst Ray, LLC · 2017 · 3 generations on3descendants
- K243943TriMed® Compression ScrewsTriMed, Inc. · 2025 · cites it directly2descendants
- K212594OSSIOfiber® StapleOSSIO, Ltd. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −2 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −1 | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated Screws | Smith & Nephew, Inc. | 2006 | 1 |
| 0 (this device) | K093676 | Omnitech Large, Trimed Compression Screw | TriMed, Inc. | 2010 | — |
| +1 | K112794 | Eos Small Bone Fixation System | TriMed, Inc. | 2012 | 4 |
| +2 | K153395 | OS2-C Compression Staple | In2bones Sas | 2016 | — |
| +3 | K163440 | Stealth Staple System | First Ray, LLC | 2017 | — |
| +1 | K243943 | TriMed® Compression Screws | TriMed, Inc. | 2025 | — |
| +3 | K212594 | OSSIOfiber® Staple | OSSIO, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories) | 1999 |
| * | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSummary page 2…oy. Surgical grade stainless steel screws complying with ASTM F138 may be made available in the future. III. Substantial Equivalence: K9931I06/1(060736 - Smith & Nephew, Smith & Nephew Bone Plate System K(962011- Synthes (USA), Synthes 7.0/7.3 nun Cannulated Screws… | 2006 |
| * | K962011 | Synthes 7.0/7.3 MM Cannulated ScrewsSummary page 2…M F138 may be made available in the future. III. Substantial Equivalence: K9931I06/1(060736 - Smith & Nephew, Smith & Nephew Bone Plate System K(962011- Synthes (USA), Synthes 7.0/7.3 nun Cannulated Screws K963 172 - Synthes (USA), Synthes 4.5 mm Cannulated Screw Omnn… | 1996 |
| * | K963172 | Synthes Sterile 4.5 MM Cannulated ScrewsSummary page 2…ivalence: K9931I06/1(060736 - Smith & Nephew, Smith & Nephew Bone Plate System K(962011- Synthes (USA), Synthes 7.0/7.3 nun Cannulated Screws K963 172 - Synthes (USA), Synthes 4.5 mm Cannulated Screw Omnnitech Large Traditional 510O(K)… | 1996 |
What descends from it? (13)
See all 132 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K112794 (TriMed, Inc., 2012) has gone furthest, with 9 descendants of its own.
- 35 other devices also cite its predicate K993106.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The TrilMed Omnitech Large System is indicated for fracture fixation of large bone and
large bone fragments, as well as fractures of the calcaneus, talus, and pelvis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093676: Omnitech Large, Trimed Compression Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093676
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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