510(k) · Cleared
ClearedBioabsorbable Interference Screws
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 Jan 28, 1999 as substantially equivalent to K945303 (Arthrex, Inc., 1996) after a 56-day review. Its family tree reaches back 1 generation to 1996. 103 later devices descend from it.
- Decided
- Jan 28, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945303 (1996). 103 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK945303 Arthrex Bioabsorbable Interference ScrewArthrex, Inc. · 1996
- This deviceK984320 Bioabsorbable Interference ScrewsSmith & Nephew, Inc. · 1999
- Descendant · cites it directly · 86 of its ownK992396 Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000
- Descendant · 2 generations on · 71 of its ownK051310 PLC ScrewSmith & Nephew, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- Descendant · 4 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- Descendant · 5 generations on · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K992396Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000 · cites it directly86descendants
- K051310PLC ScrewSmith & Nephew, Inc. · 2005 · 2 generations on71descendants
- K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · 3 generations on47descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 4 generations on38descendants
- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 5 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945303 | Arthrex Bioabsorbable Interference Screw | Arthrex, Inc. | 1996 | — |
| 0 (this device) | K984320 | Bioabsorbable Interference Screws | Smith & Nephew, Inc. | 1999 | — |
| +1 | K992396 | Biorci Screw | Smith & Nephew Endoscopy, Inc. | 2000 | — |
| +2 | K051310 | PLC Screw | Smith & Nephew, Inc. | 2005 | 24 |
| +3 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| +4 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +5 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K945303 | Arthrex Bioabsorbable Interference ScrewSummary page 1…e Screw Common Name: Screw, Fixation, Bone, Orthopedics Classification Name: Screw: 87HWC D. Predicate/Legally Marketed Devices Arthrex Bio-Interference Screw (510K # K 945303) Arthrex, Inc. 3050 North Horseshoe Drive Naples, Florida 03/ Device Description The Bioabsorbable Interferen… | 1996 |
What descends from it? (103)
See all 1033 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?
- Its one ancestor has no recall.
- Of its descendants, K992396 (Smith & Nephew Endoscopy, Inc., 2000) has gone furthest, with 86 descendants of its own.
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 Bioabsorbable Interference Screw is used for fixation of bone-tendon-bone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
The screw is indicated for single use only.
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/K984320 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984320: Bioabsorbable Interference Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984320
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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