510(k) · Cleared
ClearedArthrex TensionLoc System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HWC Screw, Fixation, Bone
Cleared on Mar 26, 2019 as substantially equivalent to K994202 (Smith & Nephew, Inc., 2000) after a 90-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Mar 26, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871037 (1987). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK871037 Cancellous Fixation Screw & Washer for Use W/ScrewConcept, Inc. · 1987
- 2 generations backK961649 Acufex Tibial Anchor Screw & Spiked WasherSmith & Nephew Endoscopy, Inc. · 1996
- 1 generation backK994202 Acufex Spiked Washer System, Acufex Suture Washer System, Acufex…Smith & Nephew, Inc. · 2000
- This deviceK183628 Arthrex TensionLoc SystemArthrex, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871037 | Cancellous Fixation Screw & Washer for Use W/Screw | Concept, Inc. | 1987 | — |
| −2 | K961649 | Acufex Tibial Anchor Screw & Spiked Washer | Smith & Nephew Endoscopy, Inc. | 1996 | — |
| −1 | K994202 | Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous… | Smith & Nephew, Inc. | 2000 | — |
| 0 (this device) | K183628 | Arthrex TensionLoc System | Arthrex, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K994202 | Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and…Summary page 4…t Code HWC Classification Name 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener Regulatory Class II Predicate Device K994202: Acufex® Washer System K151092: Arthrex Short Suture Anchors (Reference) K06… | 2000 |
| † | K151092 | Arthrex Short Suture Anchors | 2016 |
| † | K062466 | Arthrex Interference Screw | 2006 |
| † | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | 2006 |
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 32 years and passes through 4 companies; a new generation was cleared every 9.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Arthrex TensionLoc™ System is indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183628 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183628: Arthrex TensionLoc System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183628
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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