510(k) · Cleared
ClearedAcufex Tibial Anchor Screw & Spiked Washer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Endoscopy, Inc. · HWC Screw, Fixation, Bone
Cleared on Jul 16, 1996 as substantially equivalent to K871037 (Concept, Inc., 1987) after a 77-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it.
- Decided
- Jul 16, 1996
- Review
- 77 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K871037 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK871037 Cancellous Fixation Screw & Washer for Use W/ScrewConcept, Inc. · 1987
- This deviceK961649 Acufex Tibial Anchor Screw & Spiked WasherSmith & Nephew Endoscopy, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK994202 Acufex Spiked Washer System, Acufex Suture Washer System, Acufex…Smith & Nephew, Inc. · 2000
- Descendant · 2 generations on · 0 of its ownK183628 Arthrex TensionLoc SystemArthrex, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK983906 Depuy Orthotech Spiked WasherDePuy Orthopaedics, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K994202Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and…Smith & Nephew, Inc. · 2000 · cites it directly1descendant
- K183628Arthrex TensionLoc SystemArthrex, Inc. · 2019 · 2 generations on0descendants
- K983906Depuy Orthotech Spiked WasherDePuy Orthopaedics, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871037 | Cancellous Fixation Screw & Washer for Use W/Screw | Concept, Inc. | 1987 | — |
| 0 (this device) | 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 | — |
| +2 | K183628 | Arthrex TensionLoc System | Arthrex, Inc. | 2019 | — |
| +1 | K983906 | Depuy Orthotech Spiked Washer | DePuy Orthopaedics, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K871037 | Cancellous Fixation Screw & Washer for Use W/ScrewSummary page 1…fication Name: Single/Multiple component metallic bone fixation appliances and accessories Predicate/Legally Marketed Devices Concept® Soft Tissue Anchoring Implants (K871037) Synthes® Spiked Washer Device Description Acufex® Tibial Anchor Screw & Spiked Washer is a device used in soft tissue to bone… | 1987 |
| * | — | Synthes® Spiked Washer Named without a submission number |
What descends from it? (3)
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?
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Acufex® Tibial Anchor Screw & Spiked Washer is indicated for fixation of soft tissue, such as tendon and ligaments, to bone in orthopedic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961649 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961649: Acufex Tibial Anchor Screw & Spiked Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961649
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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