510(k) · Cleared
ClearedBiorci Screw
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 Jan 12, 2000 as substantially equivalent to K980841 (Smith & Nephew, Inc., 1998) and 1 other predicate after a 177-day review. Its family tree reaches back 2 generations to 1993. 86 later devices descend from it.
- Decided
- Jan 12, 2000
- Review
- 177 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915424 (1993). 5 ancestors in all. 86 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
- 1 generation backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
- This deviceK992396 Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000
- Descendant · cites it directly · 71 of its ownK051310 PLC ScrewSmith & Nephew, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- Descendant · 3 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- Descendant · 4 generations on · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017
- Descendant · 4 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- K051310PLC ScrewSmith & Nephew, Inc. · 2005 · cites it directly71descendants
- K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · 2 generations on47descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 3 generations on38descendants
- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 4 generations on29descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915424 | Arthrex Cannulated Interference Screw | Arthrex, Inc. | 1993 | — |
| −1 | K980841 | Rci Fixation Screws | Smith & Nephew, Inc. | 1998 | — |
| 0 (this device) | K992396 | Biorci Screw | Smith & Nephew Endoscopy, Inc. | 2000 | — |
| +1 | K051310 | PLC Screw | Smith & Nephew, Inc. | 2005 | 24 |
| +2 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| +3 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +4 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
| +4 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 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? (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 |
|---|---|---|---|
| * | K980841 | Rci Fixation ScrewsSummary page 1…rew common Name: Screw, Fixation, Bone, Orthopedics Classification Name: Screw: 87HWGC D. Predicate/Legally Marketed Devices RCI Fixation Screws Smith & Nephew, Inc. (K980841, 5/20/98) Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048 Bioabsorbable Interference Screw Smith & Nephew, Inc (K… | 1998 |
| * | K984320 | Bioabsorbable Interference ScrewsSummary page 1…ion Screws Smith & Nephew, Inc. (K980841, 5/20/98) Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048 Bioabsorbable Interference Screw Smith & Nephew, Inc (K984320, 1/20/99) Endoscopy Division 130 Forbes Boulevard Mansfield, MA 02048 BiuRCI Screw 510(k) 0 8 4 20F 5 E. Devi… | 1999 |
What descends from it? (86)
See all 865 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K051310 (Smith & Nephew, Inc., 2005) has gone furthest, with 71 descendants of its own.
- 1 other device also cites its predicate K980841.
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 BioRCI Screw is used for fixation of bone-tendon-bone or soft-tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
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/K992396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992396: Biorci Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992396
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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