510(k) · Cleared
Recalled · Class II · 2025Plla, HA Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Inc., Endoscopy Div. · HWC Screw, Fixation, Bone
Cleared on Apr 23, 2008 as substantially equivalent to K002274 (Smith & Nephew, Inc., 2001) and 1 other predicate after a 72-day review. Its family tree reaches back 4 generations to 1993. 22 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 23, 2008
- Review
- 72 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K915424 (1993). 8 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
- 3 generations backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
- 2 generations backK992396 Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000
- 1 generation backK051310 PLC ScrewSmith & Nephew, Inc. · 2005 · Recalled
- This deviceK080358 Plla, HA ScrewSmith & Nephew Inc., Endoscopy Div. · 2008
- Descendant · cites it directly · 21 of its ownK083635 Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
- Descendant · 2 generations on · 7 of its ownK133036 Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 5 of its ownK142230 Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK180573 Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC · 2018
- Descendant · 4 generations on · 1 of its ownK192810 Apollo Suture Anchor SystemValeris Medical · 2020
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009 · cites it directly21descendants
- K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · 2 generations on7descendants
- K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · 3 generations on5descendants
- K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC · 2018 · 2 generations on2descendants
- K192810Apollo Suture Anchor SystemValeris Medical · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915424 | Arthrex Cannulated Interference Screw | Arthrex, Inc. | 1993 | — |
| −3 | K980841 | Rci Fixation Screws | Smith & Nephew, Inc. | 1998 | — |
| −2 | K992396 | Biorci Screw | Smith & Nephew Endoscopy, Inc. | 2000 | — |
| −1 | K051310 | PLC Screw | Smith & Nephew, Inc. | 2005 | 24 |
| 0 (this device) | K080358 | Plla, HA Screw | Smith & Nephew Inc., Endoscopy Div. | 2008 | — |
| +1 | K083635 | Smith & Nephew Biosure PK Interference Screw | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| +2 | K133036 | Apollo Suture Anchor System and Titan Screws | Amendia, Inc. | 2014 | 1 |
| +3 | K142230 | Apollo Suture Anchor System and Titan Screws | Valeris Medical | 2014 | 1 |
| +2 | K180573 | Responsive Arthroscopy Interference Screw System | Responsive Arthroscopy, LLC | 2018 | — |
| +4 | K192810 | Apollo Suture Anchor System | Valeris Medical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2026 | 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 22.3 · 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 |
|---|---|---|---|
| * | K002274 | Smith & Nephew Suture Hapla Interference ScrewSummary page 1…lent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: * HAPLA Interference Screw K002274 * PLC Screw K05131O E. Description of Device The Smith & Nephew PLLA/HA Screw is an tapered interference screw for… | 2001 |
| * | K051310 | PLC ScrewSummary page 2…Technological Characteristics The Smith & Nephew PLLA/HA Screw is essentially identical to the HAPLA Interference Screw and the PLC Screw described in K002274 and K051310 respectively. The PLLA/HA Screw is a cannulated, sterile, single use bone screw, made of polylactic acid, a resorbable poly… | 2005 |
What descends from it? (22)
See all 222 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 |
|---|---|---|---|---|
| Nov 24, 2025 | Class II | Z-0957-2026 | Packaging process control | Removal of affected lot of screws due to labeling error. |
| Feb 6, 2012 | Not classified | Z-1225-2012 | Packaging process control | Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K083635 (Smith & Nephew Endoscopy, Inc., 2009) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K002274.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Smith & Nephew PLLA/HA 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/K080358 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080358: Plla, HA Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080358
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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