510(k) · Cleared
ClearedSnugFit All-Suture Anchor extension
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 Apr 17, 2023 as substantially equivalent to K203485 (Medacta International S.A., 2021) and 2 other predicates after a 48-day review. Its family tree reaches back 11 generations to 1979. 1 later device descends from it.
- Decided
- Apr 17, 2023
- Review
- 48 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K792022 (1979). 71 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 7 generations between
- 3 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 2 generations backK193461 MectaLock All-Suture AnchorsMedacta International S.A. · 2020
- 1 generation backK203485 SnugFit All-Suture AnchorMedacta International S.A. · 2021
- This deviceK230544 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 11 generations
- Root · 11 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 10 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 9 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 8 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 7 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 6 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 5 generations backK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- 4 generations backK123341 Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps…Arthrex, Inc. · 2012
- 3 generations backK150768 JuggerKnot Soft AnchorsBiomet Manufacturing Corp · 2015
- 2 generations backK193461 MectaLock All-Suture AnchorsMedacta International S.A. · 2020
- 1 generation backK203485 SnugFit All-Suture AnchorMedacta International S.A. · 2021
- This deviceK230544 SnugFit All-Suture Anchor extensionMedacta International S.A. · 2023
Most influential descendants
Showing 1 of 1 · See all- K251933SnugFit ASA ExtensionMedacta International S.A. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −10 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −9 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −8 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −7 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −6 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −5 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| −4 | K123341 | Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button… | Arthrex, Inc. | 2012 | — |
| −3 | K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015 | — |
| −2 | K193461 | MectaLock All-Suture Anchors | Medacta International S.A. | 2020 | — |
| −1 | K203485 | SnugFit All-Suture Anchor | Medacta International S.A. | 2021 | — |
| 0 (this device) | 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 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K203485 | SnugFit All-Suture AnchorSummary page 4…Classification II III. Predicate Device Substantial equivalence is claimed to the following primary predicate device: SnugFit All‐Suture Anchor, K203485, Medacta International SA. In addition, the following predicate devices are mentioned within the submission: MectaLock… | 2021 |
| * | K193461 | MectaLock All-Suture AnchorsSummary page 4…uture Anchor, K203485, Medacta International SA. In addition, the following predicate devices are mentioned within the submission: MectaLock All-Suture Anchor, K193461, Medacta International SA MectaLock TI Triple Loaded Suture Anchor, K223582, Medacta International SA IV. Device Des… | 2020 |
| * | K223582 | MectaLock TI Triple Loaded Suture AnchorSummary page 4…e devices are mentioned within the submission: MectaLock All-Suture Anchor, K193461, Medacta International SA MectaLock TI Triple Loaded Suture Anchor, K223582, Medacta International SA IV. Device Description The purpose of this submission is to gain clearance for the change in driver… | 2023 |
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 |
|---|---|---|---|
| K251933 | SnugFit ASA Extension | 2025 | 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 44 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 10 of the 71 ancestors have a recall of any class.
- Of its descendants, K251933 (Medacta International S.A., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K203485.
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. 2023, 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?
- MectaLock All-Suture Anchor
The MectaLock All-Suture anchor is intended for use in arthroscopic or open surgical approaches for
fixation of suture (soft tissue) to bone in the hip and shoulder in the following procedures:
- Hip: acetabular labral repair
- Shoulder: glenoid labrum repair; cuff rotator repair
- SnugFit All-Suture Anchor
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/K230544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230544: SnugFit All-Suture Anchor extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230544
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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