510(k) · Cleared
ClearedTBW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tri-Med, Inc. · NDL Pin, Fixation, Smooth, Metallic
Cleared on Jun 6, 2001 as substantially equivalent to K951303 (Medpac, 1995) after a 103-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.
- Decided
- Jun 6, 2001
- Review
- 103 days
- Class
- Class II
- Product code
- NDL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951303 (1995). 10 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK951303 SFCMedpac · 1995
- This deviceK010545 TBWTri-Med, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK222637 TriMed Wrist Fixation System 3TriMed, Inc. · 2022 · Recalled
- Descendant · cites it directly · 2 of its ownK243999 TriMed Ankle Fixation SystemTriMed, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK251945 TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK243987 TriMed Elbow and Forearm SystemTriMed, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK262649 Alians ForearmNewclip Technics · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K222637TriMed Wrist Fixation System 3TriMed, Inc. · 2022 · cites it directly3descendants
- K243999TriMed Ankle Fixation SystemTriMed, Inc. · 2025 · cites it directly2descendants
- K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc. · 2025 · 2 generations on1descendant
- K243987TriMed Elbow and Forearm SystemTriMed, Inc. · 2025 · cites it directly1descendant
- K262649Alians ForearmNewclip Technics · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951303 | SFC | Medpac | 1995 | — |
| 0 (this device) | K010545 | TBW | Tri-Med, Inc. | 2001 | — |
| +1 | K222637 | TriMed Wrist Fixation System 3 | TriMed, Inc. | 2022 | 1 |
| +1 | K243999 | TriMed Ankle Fixation System | TriMed, Inc. | 2025 | — |
| +2 | K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | TriMed, Inc. | 2025 | — |
| +1 | K243987 | TriMed Elbow and Forearm System | TriMed, Inc. | 2025 | — |
| +2 | K262649 | Alians Forearm | Newclip Technics | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 NDL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K951303 | SFCSummary page 2…anon sled TriMed Malleolar sled TriMed Ulnar Styloid sled (other names reserved for future sites of application) TriMed small fragment clamp and buttress pin (510(k) K951303) Smith and Nephew Kirschner wires and Steinman pins Zimmer Kirschner wires and Steinman pins Class: II, Sec. 888.3040 Smooth or… | 1995 |
What descends from it? (10)
4 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 NDL devicesNDL Pin, Fixation, Smooth, Metallic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDL
FDA has decided no NDL device since 2007.
Median 510(k) review, days · NDL
Too few NDL 510(k)s in any year since 2007 to give a median.
Recalls per year · NDL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDL
1in 2021
MAUDE reports naming product code NDL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecration, patella, medial malleolus, lateral malloolus, distal ulna, distal humerus, and proximal humerus.
The decision to use a specific implant as well as the size and shape of the implant used must be based on sound medical judgement that takes into consideration factors such as the circumstances and configuration of the injury.
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/K010545 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010545: TBW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010545
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026