510(k) · Cleared
ClearedBiorci Screw
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 Aug 8, 2003 as substantially equivalent to K992396 (Smith & Nephew Endoscopy, Inc., 2000) after an 18-day review. Its family tree reaches back 3 generations to 1993. 16 later devices descend from it.
- Decided
- Aug 8, 2003
- Review
- 18 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K915424 (1993). 6 ancestors in all. 16 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
- 2 generations backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
- 1 generation backK992396 Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000
- This deviceK032224 Biorci ScrewSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK083619 Parcus Tintanium Interference Screw, Models: 10001-10012…Parcus Medical, LLC · 2009
- Descendant · 2 generations on · 4 of its ownK091093 Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009
- Descendant · cites it directly · 3 of its ownK040542 Smith & Nephew GTS Sleeve and GTS Tapered ScrewSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK193497 Fixone Biocomposite Interference ScrewAju Pharm Co., Ltd. · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK170877 Parcus SLiK Fix ScrewParcus Medical · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K083619Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020Parcus Medical, LLC · 2009 · cites it directly7descendants
- K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009 · 2 generations on4descendants
- K040542Smith & Nephew GTS Sleeve and GTS Tapered ScrewSmith & Nephew, Inc. · 2004 · cites it directly3descendants
- K193497Fixone Biocomposite Interference ScrewAju Pharm Co., Ltd. · 2021 · cites it directly1descendant
- K170877Parcus SLiK Fix ScrewParcus Medical · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915424 | Arthrex Cannulated Interference Screw | Arthrex, Inc. | 1993 | — |
| −2 | K980841 | Rci Fixation Screws | Smith & Nephew, Inc. | 1998 | — |
| −1 | K992396 | Biorci Screw | Smith & Nephew Endoscopy, Inc. | 2000 | — |
| 0 (this device) | K032224 | Biorci Screw | Smith & Nephew, Inc. | 2003 | — |
| +1 | K083619 | Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016… | Parcus Medical, LLC | 2009 | — |
| +2 | K091093 | Parcus Ppek CF Interference Screw | Parcus Medical, LLC | 2009 | — |
| +1 | K040542 | Smith & Nephew GTS Sleeve and GTS Tapered Screw | Smith & Nephew, Inc. | 2004 | — |
| +1 | K193497 | Fixone Biocomposite Interference Screw | Aju Pharm Co., Ltd. | 2021 | 8 |
| +3 | K170877 | Parcus SLiK Fix Screw | Parcus Medical | 2017 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K992396 | Biorci ScrewSummary page 1…ubstantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device(s) in commercial distribution: BioRCI@Screw, K992396. E. Dcescription of Device Tlie Modified BioRCI@Screw is an interference screw in the range of 7-12mm in diameter and 20-3… | 2000 |
What descends from it? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083619 | Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020 | 2009 | 7 |
| K040542 | Smith & Nephew GTS Sleeve and GTS Tapered Screw | 2004 | 3 |
| K193497 | Fixone Biocomposite Interference Screw | 2021 | 1 |
| K230655 | PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw | 2023 | 0 |
| K161174 | Nanova Interference Screw | 2016 | 0 |
| K143172 | ACL SMART System | 2015 | 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 10 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K083619 (Parcus Medical, LLC, 2009) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K992396.
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 AnteriorRosterior Cruciate Ligament (ACLRCL) reconstruction procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032224: 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/K032224
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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