510(k) · Cleared
ClearedAllofix Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Musculoskeletal Transplant Foundation · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Mar 16, 2006 as substantially equivalent to K042038 (Musculoskeletal Transplant Foundation, 2004) after a 105-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Mar 16, 2006
- Review
- 105 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904436 (1990). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 4 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 3 generations backK993115 Multitak SSBonutti Research, Inc. · 1999
- 2 generations backK011985 Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc. · 2001
- 1 generation backK042038 MTF Allograft AnchorMusculoskeletal Transplant Foundation · 2004
- This deviceK053339 Allofix AnchorMusculoskeletal Transplant Foundation · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −5 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −4 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −3 | K993115 | Multitak SS | Bonutti Research, Inc. | 1999 | — |
| −2 | K011985 | Smith & Nephew Phoenix 5.0 Allograft Anchor Kit | Smith & Nephew, Inc. | 2001 | — |
| −1 | K042038 | MTF Allograft Anchor | Musculoskeletal Transplant Foundation | 2004 | — |
| 0 (this device) | K053339 | Allofix Anchor | Musculoskeletal Transplant Foundation | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K042038 | MTF Allograft AnchorSummary page 2…bone in orthopedic procedures. N. PREDICATE DEVICE The AllofixTM Anchor is substantially equivalent to the MTF Allograft AnchorTM (FDA cleared, K042038). 0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS Both the AllofixTM Anchor and the Allograft Anchor MT have the… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
The AllofixfM Anchor is indicated for use in soft tissue approximation and/or ligation of orthopaedic procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053339 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053339: Allofix Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053339
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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