510(k) · Cleared
ClearedSnugFit All-Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 19, 2021 as substantially equivalent to K150768 (Biomet Manufacturing Corp, 2015) and 1 other predicate after a 53-day review. Its family tree reaches back 10 generations to 1979. 2 later devices descend from it.
- Decided
- Jan 19, 2021
- Review
- 53 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K792022 (1979). 61 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations between
- 3 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 2 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 1 generation backK193461 MectaLock All-Suture AnchorsMedacta International S.A. · 2020
- This deviceK203485 SnugFit All-Suture AnchorMedacta International S.A. · 2021
- Descendant · cites it directly · 1 of its ownK230544 SnugFit All-Suture Anchor extensionMedacta International S.A. · 2023
- Descendant · cites it directly · 0 of its ownK251933 SnugFit ASA ExtensionMedacta International S.A. · 2025
Show all 10 generations
- Root · 10 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 9 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 8 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 7 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 6 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 5 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 4 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 3 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 2 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 1 generation backK193461 MectaLock All-Suture AnchorsMedacta International S.A. · 2020
- This deviceK203485 SnugFit All-Suture AnchorMedacta International S.A. · 2021
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 |
|---|---|---|---|---|---|
| −10 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −9 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −8 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −7 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −6 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −5 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −4 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| −3 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| −2 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| −1 | K193461 | MectaLock All-Suture Anchors | Medacta International S.A. | 2020 | — |
| 0 (this device) | K203485 | SnugFit All-Suture Anchor | Medacta International S.A. | 2021 | — |
| +1 | K230544 | SnugFit All-Suture Anchor extension | Medacta International S.A. | 2023 | — |
| +1 | K251933 | SnugFit ASA Extension | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K150768 | JuggerKnot Soft AnchorsSummary page 4…lassification II III. Predicate Device Substantial equivalence is claimed to the following primary predicate device: JuggerKnot Soft Anchors, K150768, Biomet Manufacturing Corp. The following has been identified as a secondary predicate device: MectaLock All-Suture… | 2015 |
| * | K193461 | MectaLock All-Suture AnchorsSummary page 4…uggerKnot Soft Anchors, K150768, Biomet Manufacturing Corp. The following has been identified as a secondary predicate device: MectaLock All-Suture Anchor, K193461, Medacta International SA In addition, the following reference devices are referenced within the submission: Mecta… | 2020 |
| † | K190474 | MectaLock PEEK Suture Anchor | 2019 |
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 42 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- 10 of the 61 ancestors have a recall of any class.
- Of its descendants, K230544 (Medacta International S.A., 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K150768.
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. 2021, 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 SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures:
- Hip: acetabular labral repair
- Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203485 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203485: SnugFit All-Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203485
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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