510(k) · Cleared
Recalled · 2006RBM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KGS Retention Device, Suture
Cleared on Mar 12, 2002 as substantially equivalent to K002261 (Smith & Nephew, Inc., 2000) after a 27-day review. Its family tree reaches back 2 generations to 1993. 16 later devices descend from it. It has been recalled once.
- Decided
- Mar 12, 2002
- Review
- 27 days
- Class
- Class I
- Product code
- KGS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925573 (1993). 3 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK925573 Acufex T-BarAcufex Microsurgical, Inc. · 1993 · Recalled
- 1 generation backK002261 MR-IIISmith & Nephew, Inc. · 2000
- This deviceK020480 RBMSmith & Nephew, Inc. · 2002
- 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 · 9 of its ownK073149 Meniscal CinchArthrex, Inc. · 2008
- Descendant · 3 generations on · 6 of its ownK132043 Arthrex SpeedcinchArthrex, Inc. · 2013
- Descendant · 3 generations on · 2 of its ownK190707 Arthrex SoftStitchArthrex, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K072322Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair SystemsSmith & Nephew, Inc. · 2007 · cites it directly15descendants
- K073149Meniscal CinchArthrex, Inc. · 2008 · 2 generations on9descendants
- K132043Arthrex SpeedcinchArthrex, Inc. · 2013 · 3 generations on6descendants
- K190707Arthrex SoftStitchArthrex, Inc. · 2020 · 3 generations on2descendants
- K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925573 | Acufex T-Bar | Acufex Microsurgical, Inc. | 1993 | 1 |
| −1 | K002261 | MR-III | Smith & Nephew, Inc. | 2000 | — |
| 0 (this device) | K020480 | RBM | Smith & Nephew, Inc. | 2002 | — |
| +1 | K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | Smith & Nephew, Inc. | 2007 | — |
| +2 | K073149 | Meniscal Cinch | Arthrex, Inc. | 2008 | — |
| +3 | K132043 | Arthrex Speedcinch | Arthrex, Inc. | 2013 | — |
| +3 | K190707 | Arthrex SoftStitch | Arthrex, Inc. | 2020 | — |
| +4 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2019 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 KGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K002261 | MR-IIISummary page 1…bable, Polyester Classification Name: Suture Retention Device (KGS) Suture, Nonabsorbable, Synthetic, Polyester (GAS) D. Predicate Device MR-III previously cleared by K002261. E. Description of Device The RBM is a suture retention device manufactured from polyester suture, poly(L-lactide) bar, - stainl… | 2000 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072322 | Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems | 2007 | 15 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2006 | Not classified | Z-0798-06 | Other | The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K072322 (Smith & Nephew, Inc., 2007) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K002261.
How does its category compare?
All KGS devicesKGS Retention Device, Suture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGS
FDA has decided no KGS device since 2007.
Median 510(k) review, days · KGS
Too few KGS 510(k)s in any year since 2007 to give a median.
Recalls per year · KGS
No recall names KGS since 2007.
Adverse event reports per year · KGS
3in 2025
MAUDE reports naming product code KGS, 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 | 26 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RBM 1s intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair.
The indications for the RBM are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repait), rotator cuff repai, meniscal repair, and gastrostormy.
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/K020480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020480: RBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020480
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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