510(k) · Cleared
ClearedPLC Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Inc., Endoscopy Div. · HRS Plate, Fixation, Bone
Cleared on Mar 6, 2007 as substantially equivalent to K053344 (Smith & Nephew, Inc., 2006) after an 81-day review. Its family tree reaches back 3 generations to 1996. 122 later devices descend from it.
- Decided
- Mar 6, 2007
- Review
- 81 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961555 (1996). 4 ancestors in all. 122 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 2 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- This deviceK063726 PLC Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2007
- Descendant · cites it directly · 121 of its ownK071586 Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · Recalled
- Descendant · 2 generations on · 46 of its ownK082215 Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · Recalled
- Descendant · 2 generations on · 41 of its ownK093428 Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009
- Descendant · 2 generations on · 29 of its ownK121018 Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless…Smith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 21 of its ownK083635 Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2007 · cites it directly121descendants
- K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division · 2008 · 2 generations on46descendants
- K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009 · 2 generations on41descendants
- K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc. · 2012 · 2 generations on29descendants
- K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc. · 2009 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −2 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −1 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| 0 (this device) | K063726 | PLC Suture Anchor | Smith & Nephew Inc., Endoscopy Div. | 2007 | — |
| +1 | K071586 | Bioraptor 2.3 PK Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2007 | 1 |
| +2 | K082215 | Osteoraptor Suture Anchor | Smith & Nephew Inc., Endoscopy Division | 2008 | 9 |
| +2 | K093428 | Smith & Nephew Knotless Instability Anchor | Smith & Nephew Endoscopy, Inc. | 2009 | — |
| +2 | K121018 | Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an | Smith & Nephew, Inc. | 2012 | — |
| +2 | K083635 | Smith & Nephew Biosure PK Interference Screw | Smith & Nephew Endoscopy, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 6 | 0 |
| 2015 | 10 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 10 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 13 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 |
|---|---|---|---|
| * | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSummary page 1…degradable, soft tissue D. Predicate Devices The PLC Suture Anchor is substantially equivalent to the Smith & Nephew BioRaptor Suture Anchor (K053344). E. Description of Device Preloaded 2.3 mm suture anchor manufactured from PLC incorporating ultra high molecular wei… | 2006 |
What descends from it? (122)
See all 1221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071586 | Bioraptor 2.3 PK Suture Anchor | 2007 | 121 |
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 11 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K071586 (Smith & Nephew Inc., Endoscopy Division, 2007) has gone furthest, with 121 descendants of its own.
- 15 other devices also cite its predicate K053344.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Smith & Nephew PLC suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP lesion repairs Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis Foot and Ankle Hallux valgus repairs Medial or lateral instablility…
Read the full statement (114 words)
The Smith & Nephew PLC suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Capsular Stabilization
Bankhart Repair
Anterior Shoulder Instability Repair
SLAP lesion repairs
Capsular Shift or capsulolabral
reconstructions
Acromioclavicular separation repairs
Deltoid Repairs
Rotator Cuff tear repairs
Biceps tenodesis
Foot and Ankle
Hallux valgus repairs
Medial or lateral instablility
repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon
repairs/reconstructions
Bunionectomy
Elbow
Ulnar or radial collateral ligament
reconstructions
Lateral epicondylitis repair
Biceps tendon reattachment
Knee
Extra-capsular repairs:
medial collateral ligament
lateral collateral ligament
posterior oblique ligament
Patellar realignment and tendon repairs:
vastus medialis obliquous advancement
Iliotibial band tenodesis
Hip
Capsular repair
Acetabular labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063726 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063726: PLC Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063726
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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