510(k) · Cleared
ClearedCols® Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres Industrie · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 5, 2013 as substantially equivalent to K080974 (Fournitures Hospitalieres Industrie, 2008) after a 358-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Mar 5, 2013
- Review
- 358 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915424 (1993). 11 ancestors in all, the oldest K922559 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
- 3 generations backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
- 2 generations backK992945 Rci Fixation Screws (with Assorted Sizes)Smith & Nephew, Inc. · 1999
- 1 generation backK080974 TLS Fixation SystemFournitures Hospitalieres Industrie · 2008
- This deviceK120740 Cols® Fixation SystemFournitures Hospitalieres Industrie · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915424 | Arthrex Cannulated Interference Screw | Arthrex, Inc. | 1993 | — |
| −3 | K980841 | Rci Fixation Screws | Smith & Nephew, Inc. | 1998 | — |
| −2 | K992945 | Rci Fixation Screws (with Assorted Sizes) | Smith & Nephew, Inc. | 1999 | — |
| −1 | K080974 | TLS Fixation System | Fournitures Hospitalieres Industrie | 2008 | — |
| 0 (this device) | K120740 | Cols® Fixation System | Fournitures Hospitalieres Industrie | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K080974 | TLS Fixation SystemSummary page 1…Manufacturer: Foumnitures Hospitalibes Industrie Device Trade Name: TLS® Fixation System 5 10 (K): K080974 5-5. Device Description: The CoLS® Fixation System is composed of the following elements: - The CoLS® tendon anchorin… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K080974.
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. 2013, 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 CoLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120740 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120740: Cols® 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/K120740
Report an extraction error
Are you the manufacturer?
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