510(k) · Cleared
ClearedMR-III
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · GAS Suture, Nonabsorbable, Synthetic, Polyester
Cleared on Oct 23, 2000 as substantially equivalent to K925573 (Acufex Microsurgical, Inc., 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1993. 30 later devices descend from it.
- Decided
- Oct 23, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- GAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925573 (1993). 2 ancestors in all. 30 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- This deviceK002261 MR-IIISmith & Nephew, Inc. · 2000
- Descendant · cites it directly · 17 of its ownK092508 Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse…Smith & Nephew, Inc. · 2010 · Recalled
- Descendant · cites it directly · 16 of its ownK020480 RBMSmith & Nephew, Inc. · 2002 · Recalled
- Descendant · cites it directly · 15 of its ownK072322 Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007
- Descendant · 2 generations on · 12 of its ownK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK073149 Meniscal CinchArthrex, Inc. · 2008
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K092508Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB…Smith & Nephew, Inc. · 2010 · cites it directly17descendants
- K020480RBMSmith & Nephew, Inc. · 2002 · cites it directly16descendants
- K072322Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007 · cites it directly15descendants
- K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Smith & Nephew, Inc. · 2012 · 2 generations on12descendants
- K073149Meniscal CinchArthrex, Inc. · 2008 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| 0 (this device) | K002261 | MR-III | Smith & Nephew, Inc. | 2000 | — |
| +1 | K092508 | Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix… | Smith & Nephew, Inc. | 2010 | 3 |
| +1 | K020480 | RBM | Smith & Nephew, Inc. | 2002 | 1 |
| +1 | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | Smith & Nephew, Inc. | 2007 | — |
| +2 | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra… | Smith & Nephew, Inc. | 2012 | — |
| +2 | K073149 | Meniscal Cinch | Arthrex, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 GAS? 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 GAS device
- #1 K203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture…score 1.9 · 6 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K925573 | Acufex T-BarSummary page 1…etention Device (KGS) Suture, Nonabsorbable, Synthetic, Polyester (GAS) D. Predicate Devices T-Fix previously cleared by K925573 and K942442. E. Description of Device The MR-III is a suture retention device manufactured from polyester suture, polya… | 1993 |
| * | K942442 | Acufex T-Fix Delivery SystemSummary page 1…ice (KGS) Suture, Nonabsorbable, Synthetic, Polyester (GAS) D. Predicate Devices T-Fix previously cleared by K925573 and K942442. E. Description of Device The MR-III is a suture retention device manufactured from polyester suture, polyacetal bar, s… | 1994 |
What descends from it? (30)
See all 303 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 GAS devicesGAS Suture, Nonabsorbable, Synthetic, Polyester: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAS
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GAS
Too few GAS 510(k)s in any year since 2007 to give a median.
Recalls per year · GAS
No recall names GAS since 2007.
Adverse event reports per year · GAS
3in 2025
MAUDE reports naming product code GAS, 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 | 35 |
| 2008 | 0 | — | 0 | 47 |
| 2009 | 0 | — | 0 | 56 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 25 |
| 2012 | 0 | — | 0 | 73 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MR-III is intended for use as a suture retention device to facilitate pecutaneous or endoscopic soft tissue repair.
The indications for the MR-III are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K002261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002261: MR-III.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002261
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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