510(k) · Cleared
Recalled · 2007PLC 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 Jul 26, 2005 as substantially equivalent to K992396 (Smith & Nephew Endoscopy, Inc., 2000) after a 68-day review. Its family tree reaches back 3 generations to 1993. 71 later devices descend from it. It has been recalled 24 times.
- Decided
- Jul 26, 2005
- Review
- 68 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 24
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915424 (1993). 6 ancestors in all. 71 later devices descend from it, 2 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 deviceK051310 PLC ScrewSmith & Nephew, Inc. · 2005
- Descendant · cites it directly · 47 of its ownK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- Descendant · 2 generations on · 38 of its ownK151342 Arthrex SwiveLock AnchorsArthrex, Inc. · 2016
- Descendant · 3 generations on · 29 of its ownK171141 Arthrex SwiveLock AnchorsArthrex, Inc. · 2017
- Descendant · 3 generations on · 28 of its ownK180768 Arthrex SwiveLock AnchorsArthrex, Inc. · 2018
- Descendant · cites it directly · 22 of its ownK080358 Plla, HA ScrewSmith & Nephew Inc., Endoscopy Div. · 2008 · Recalled
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
2007high 10 (2023) · low 0 (2013)2026
Most influential descendants
Showing 5 of 71 · See all- K071176Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007 · cites it directly47descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 2 generations on38descendants
- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 3 generations on29descendants
- K180768Arthrex SwiveLock AnchorsArthrex, Inc. · 2018 · 3 generations on28descendants
- K080358Plla, HA ScrewSmith & Nephew Inc., Endoscopy Div. · 2008 · cites it directly22descendants
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) | K051310 | PLC Screw | Smith & Nephew, Inc. | 2005 | — |
| +1 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| +2 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +3 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
| +3 | K180768 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2018 | — |
| +1 | K080358 | Plla, HA Screw | Smith & Nephew Inc., Endoscopy Div. | 2008 | 2 |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K1002274 | HAPLA Interference Screw Number could not be read Summary page 1…ially equivalent in Intended Use and Fundamental Technology to the following legally marketed device in commercial distribution: * HAPLA Interference Screw K1002274 * BioRCI Screw K992396… | |
| * | K992396 | Biorci ScrewSummary page 1…e and Fundamental Technology to the following legally marketed device in commercial distribution: * HAPLA Interference Screw K1002274 * BioRCI Screw K992396 28A === Page 2 ==… | 2000 |
What descends from it? (71)
See all 712 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2007 | Not classified | Z-0593-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0604-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0609-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0610-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0596-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0598-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0600-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0605-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0606-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0607-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0608-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0611-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0595-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0597-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0599-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0601-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0602-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0603-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0612-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0615-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0616-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0594-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0613-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
| Aug 21, 2007 | Not classified | Z-0614-2008 | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
The 5 latest of 24 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K071176 (Arthrex, Inc., 2007) has gone furthest, with 47 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
2007high 41 (2015) · low 15 (2025)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
2007high 167 (2022) · low 75 (2020)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
2007high 33 (2008) · low 0 (2023)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
2007high 5,463 (2019) · low 651 (2009)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 Smith & Nephew PLC Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051310: PLC Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051310
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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