510(k) · Cleared
ClearedFiji Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sportwelding GmbH · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jan 19, 2018 as substantially equivalent to K063479 (Arthrex, Inc., 2006) after a 268-day review. Its family tree reaches back 2 generations to 2005. 2 later devices descend from it.
- Decided
- Jan 19, 2018
- Review
- 268 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050749 (2005). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK050749 Arthrex Tak FamilyArthrex, Inc. · 2005
- 1 generation backK063479 Arthrex PushlockArthrex, Inc. · 2006
- This deviceK171228 Fiji AnchorSportwelding GmbH · 2018
- Descendant · cites it directly · 1 of its ownK240288 SF Push- in AnchorSurgical Fusion Technologies GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK260294 SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
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 |
|---|---|---|---|---|---|
| −2 | K050749 | Arthrex Tak Family | Arthrex, Inc. | 2005 | — |
| −1 | K063479 | Arthrex Pushlock | Arthrex, Inc. | 2006 | — |
| 0 (this device) | K171228 | Fiji Anchor | Sportwelding GmbH | 2018 | — |
| +1 | K240288 | SF Push- in Anchor | Surgical Fusion Technologies GmbH | 2024 | — |
| +2 | K260294 | SF Push-in Anchor | Surgical Fusion Technologies GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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? (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 |
|---|---|---|---|
| * | K063479 | Arthrex PushlockSummary page 4…metallic bone fixation fastener (21 CFR 888.3040) Nonabsorbable poly(ethylene terephthalate) surgical suture (21 CFR 878.5000) Predicate Devices • K063479 Arthrex’s Bio-PushLock (Primary) • K143063 Stryker’s SonicAnchor System (Reference) Indications for Use The… | 2006 |
| † | K143063 | Stryker SonicPin System, Stryker SonicAnchor System | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240288 | SF Push- in Anchor | 2024 | 1 |
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 13 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240288 (Surgical Fusion Technologies GmbH, 2024) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K063479.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Fiji Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder. The Fiji Anchor is designed only to be inserted with the BoneWelder 150-W1 system. Specific indications are listed below: Elbow: Ulnar or Radial Collateral Ligament Reconstruction Shoulder: Bankart Repair, Capsular Shift or Capsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction…
Read the full statement (102 words)
The Fiji Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder. The Fiji Anchor is designed only to be inserted with the BoneWelder 150-W1 system. Specific indications are listed below:
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Bankart Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171228: Fiji Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171228
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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