510(k) · Cleared
ClearedTLS Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres Industrie · HWC Screw, Fixation, Bone
Cleared on Jul 1, 2008 as substantially equivalent to K980155 (Smith & Nephew, Inc., 1998) and 2 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it.
- Decided
- Jul 1, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K915424 (1993). 10 ancestors in all, the oldest K922559 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
- 2 generations backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
- 1 generation backK992945 Rci Fixation Screws (with Assorted Sizes)Smith & Nephew, Inc. · 1999
- This deviceK080974 TLS Fixation SystemFournitures Hospitalieres Industrie · 2008
- Descendant · cites it directly · 0 of its ownK120740 Cols® Fixation SystemFournitures Hospitalieres Industrie · 2013
- Descendant · cites it directly · 0 of its ownK113591 Cols PeekFournitures Hospitalieres Industrie · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915424 | Arthrex Cannulated Interference Screw | Arthrex, Inc. | 1993 | — |
| −2 | K980841 | Rci Fixation Screws | Smith & Nephew, Inc. | 1998 | — |
| −1 | K992945 | Rci Fixation Screws (with Assorted Sizes) | Smith & Nephew, Inc. | 1999 | — |
| 0 (this device) | K080974 | TLS Fixation System | Fournitures Hospitalieres Industrie | 2008 | — |
| +1 | K120740 | Cols® Fixation System | Fournitures Hospitalieres Industrie | 2013 | — |
| +1 | K113591 | Cols Peek | Fournitures Hospitalieres Industrie | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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 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? (3)
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 |
|---|---|---|---|
| * | K980155 | Endobutton Continuous LoopSummary page 1…Manufacturer: Smith & Nephew Device Trade Name: EndoButton TM Continuous Loop 510 (K): K980155 Date cleared: 04/01/1998 Manufacturer: F.H INDUSTRIE… | 1998 |
| * | K060367 | TenoligSummary page 1…/1998 Manufacturer: F.H INDUSTRIE Device Trade Name: Tenolig® 510 (K): K060367 Date cleared: 09/08/2006 Fournitures Hospitali~res Industrie… | 2006 |
| * | K992945 | Rci Fixation Screws (with Assorted Sizes)Summary page 2…screw T M 510 (K): K992945 Date cleared 11/18/1999 5-5. DEVICE DESCRIPTION: The TLS® Fixation System is compos… | 1999 |
What descends from it? (2)
2 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 15 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K120740 (Fournitures Hospitalieres Industrie, 2013) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K980155.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 TLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopaedic 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/K080974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080974: TLS 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/K080974
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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