510(k) · Cleared
ClearedTRUESPAN Meniscal Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 24, 2016 as substantially equivalent to K121861 (Smith & Nephew, Inc., 2012) and 1 other predicate after a 94-day review. Its family tree reaches back 4 generations to 2005. 1 later device descends from it.
- Decided
- Mar 24, 2016
- Review
- 94 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K050021 (2005). 11 ancestors in all, the oldest K925573 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK050021 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2005
- 3 generations backK070216 Vari-Lase Bright Tip FiberVascular Solutions, Inc. · 2007
- 2 generations backK072332 Vari-Lase Wire FiberVascular Solutions, Inc. · 2008 · Recalled
- 1 generation backK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012
- This deviceK153667 TRUESPAN Meniscal Repair SystemMedos International SARL · 2016
- Descendant · cites it directly · 0 of its ownK233601 Fixone Meniscal RepairAju Pharm Co., Ltd. · 2024 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K233601Fixone Meniscal RepairAju Pharm Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050021 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2005 | — |
| −3 | K070216 | Vari-Lase Bright Tip Fiber | Vascular Solutions, Inc. | 2007 | — |
| −2 | K072332 | Vari-Lase Wire Fiber | Vascular Solutions, Inc. | 2008 | 1 |
| −1 | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra… | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K153667 | TRUESPAN Meniscal Repair System | Medos International SARL | 2016 | — |
| +1 | K233601 | Fixone Meniscal Repair | Aju Pharm Co., Ltd. | 2024 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 3 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Summary page 5…II, regulated per 21 CFR 888.3040. Classification ƒ Orthopedic panel ƒ Predicate: Fast-Fix 360 Meniscal Repair System (K121861, K092508; Smith & Nephew) Predicate ƒ Reference: Ultra Fast-Fix Meniscal Repair S… | 2012 |
| * | K092508 | Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…Summary page 5…regulated per 21 CFR 888.3040. Classification ƒ Orthopedic panel ƒ Predicate: Fast-Fix 360 Meniscal Repair System (K121861, K092508; Smith & Nephew) Predicate ƒ Reference: Ultra Fast-Fix Meniscal Repair System (K1… | 2010 |
| † | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | 2007 |
| † | K092836 | Omnispan Meniscal Repair System/0 Degree, Model 228140, Rapidloc A2 Meniscal Repair… | 2010 |
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 |
|---|---|---|---|
| K233601 | Fixone Meniscal Repair | 2024 | 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 11 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K233601 (Aju Pharm Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K121861.
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. 2016, 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 TRUESPAN Meniscal Repair System is intended for use in meniscal repairs and meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
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/K153667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153667: TRUESPAN Meniscal Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153667
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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