510(k) · Cleared
ClearedTenodesis Cross Screw, Interference Screw, Suture Bead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TriMed, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Oct 17, 2008 as substantially equivalent to K033717 (Bonutti Research, Inc., 2004) after a 156-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Oct 17, 2008
- Review
- 156 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904436 (1990). 18 ancestors in all, the oldest K901456 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 4 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 3 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 2 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 1 generation backK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
- This deviceK081348 Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK091156 Trimed Sterile ProductTriMed, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091156Trimed Sterile ProductTriMed, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −4 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −3 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −2 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −1 | K033717 | Transet Fracture Fixation System | Bonutti Research, Inc. | 2004 | — |
| 0 (this device) | K081348 | Tenodesis Cross Screw, Interference Screw, Suture Bead | TriMed, Inc. | 2008 | — |
| +1 | K091156 | Trimed Sterile Product | TriMed, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K033717 | Transet Fracture Fixation SystemSummary page 2…nents are intended to allow the implants to accommodate variations in patient size, graft size and sites of application. itI. Substantial Equivalence: K033717 - Transet Fracture Fixation System KeAi Anderson, MS, RAC Regulatory Affairs Specialist DEPARTMENT OF… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091156 | Trimed Sterile Product | 2009 | 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 18 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K091156 (TriMed, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033717.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The TriMed Suture Bead is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting. The Suture Beads are also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment. The…
Read the full statement (170 words)
The TriMed Suture Bead is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting. The Suture Beads are also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment.
The TriMed Suture Bead is not indicated for use within intra-articular sites.
The TriMed Tenodesis Cross Screw and interference Screw are intended to be used as an aid for fixation of soft tissue grafts to bone. Specific indications for use include:
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand and wrist.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081348 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081348: Tenodesis Cross Screw, Interference Screw, Suture Bead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081348
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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