510(k) · Cleared
ClearedRci Fixation Screws (with Assorted Sizes)
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 Nov 18, 1999 as substantially equivalent to K980841 (Smith & Nephew, Inc., 1998) after a 78-day review. Its family tree reaches back 2 generations to 1993. 8 later devices descend from it.
- Decided
- Nov 18, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915424 (1993). 3 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
- 1 generation backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
- This deviceK992945 Rci Fixation Screws (with Assorted Sizes)Smith & Nephew, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK212547 Quick-Start ScrewsInnovate Orthopaedics Limited · 2021
- Descendant · cites it directly · 2 of its ownK080974 TLS Fixation SystemFournitures Hospitalieres Industrie · 2008
- Descendant · 2 generations on · 1 of its ownK231819 Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics Limited · 2023
- Descendant · 3 generations on · 0 of its ownK242442 Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK120740 Cols® Fixation SystemFournitures Hospitalieres Industrie · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K212547Quick-Start ScrewsInnovate Orthopaedics Limited · 2021 · cites it directly2descendants
- K080974TLS Fixation SystemFournitures Hospitalieres Industrie · 2008 · cites it directly2descendants
- K231819Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics Limited · 2023 · 2 generations on1descendant
- K242442Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics, Ltd. · 2025 · 3 generations on0descendants
- K120740Cols® Fixation SystemFournitures Hospitalieres Industrie · 2013 · 2 generations on0descendants
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) | K992945 | Rci Fixation Screws (with Assorted Sizes) | Smith & Nephew, Inc. | 1999 | — |
| +1 | K212547 | Quick-Start Screws | Innovate Orthopaedics Limited | 2021 | — |
| +1 | K080974 | TLS Fixation System | Fournitures Hospitalieres Industrie | 2008 | — |
| +2 | K231819 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics Limited | 2023 | — |
| +3 | K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics, Ltd. | 2025 | — |
| +2 | K120740 | Cols® Fixation System | Fournitures Hospitalieres Industrie | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K980841 | Rci Fixation ScrewsSummary page 2…fied Screw, Surgical as a Class Il device. (21 CFR § 888.3040) RCI Fixation Screws 510(k) hi D. Predicate/Legally Marketed Devices RCI Fixation Screw (K980841): , - Smith + Nephew Inc., Endoscopy 274 Division 130 FORBES BLVD K@i >2 55 MANSFIELD, MA 02048 E. Device Description RCI Fixa… | 1998 |
What descends from it? (8)
4 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 6 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K212547 (Innovate Orthopaedics Limited, 2021) has gone furthest, with 2 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?
RCI Fixation Screws are used for interference fixation of Bone-Tendon-Bone or soft tissue grafts in anterior or posterior cruciate ligament 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/K992945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992945: Rci Fixation Screws (with Assorted Sizes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992945
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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