510(k) · Cleared
ClearedAcufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and Spiked Washer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HWC Screw, Fixation, Bone
Cleared on Feb 25, 2000 as substantially equivalent to K961649 (Smith & Nephew Endoscopy, Inc., 1996) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Feb 25, 2000
- Review
- 74 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K871037 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK871037 Cancellous Fixation Screw & Washer for Use W/ScrewConcept, Inc. · 1987
- 1 generation backK961649 Acufex Tibial Anchor Screw & Spiked WasherSmith & Nephew Endoscopy, Inc. · 1996
- This deviceK994202 Acufex Spiked Washer System, Acufex Suture Washer System, Acufex…Smith & Nephew, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK183628 Arthrex TensionLoc SystemArthrex, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183628Arthrex TensionLoc SystemArthrex, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871037 | Cancellous Fixation Screw & Washer for Use W/Screw | Concept, Inc. | 1987 | — |
| −1 | K961649 | Acufex Tibial Anchor Screw & Spiked Washer | Smith & Nephew Endoscopy, Inc. | 1996 | — |
| 0 (this device) | K994202 | Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous… | Smith & Nephew, Inc. | 2000 | — |
| +1 | K183628 | Arthrex TensionLoc System | Arthrex, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K961649 | Acufex Tibial Anchor Screw & Spiked WasherSummary page 2…ry and Truthful and Accurate Statement D. Predicate/Legally Marketed Devices Acufex® Tibial Anchor Screw and DePuy OrthoTech Soft Tissue Fixation Washer Spiked Washer (K961649): (K910229) Smith + Nephew Inc., Endoscopy DePuy OrthoTech, Inc. Division 130 FORBES BLVD 700 Orthopaedic Drive MANSFIELD, MA 020… | 1996 |
| * | K910229 | Soft Tissue Suture Washer/3 Hole WasherSummary page 2…hful and Accurate Statement D. Predicate/Legally Marketed Devices Acufex® Tibial Anchor Screw and DePuy OrthoTech Soft Tissue Fixation Washer Spiked Washer (K961649): (K910229) Smith + Nephew Inc., Endoscopy DePuy OrthoTech, Inc. Division 130 FORBES BLVD 700 Orthopaedic Drive MANSFIELD, MA 02048 Warsaw,… | 1991 |
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 |
|---|---|---|---|
| K183628 | Arthrex TensionLoc System | 2019 | 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 13 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K183628 (Arthrex, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K961649.
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® Washer Systems are indicated for fixation of soft tissue, such as tendons 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/K994202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994202: Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and Spiked Washer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994202
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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