510(k) · Cleared
ClearedTwinfix PK FP Suture Anchor
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 Mar 4, 2008 as substantially equivalent to K051219 (Arthrex, Inc., 2005) after an 82-day review. Its family tree reaches back 2 generations to 1997. 64 later devices descend from it.
- Decided
- Mar 4, 2008
- Review
- 82 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971723 (1997). 3 ancestors in all. 64 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
- 1 generation backK051219 PushlockArthrex, Inc. · 2005
- This deviceK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 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 · cites it directly · 29 of its ownK093897 Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
- Descendant · 2 generations on · 16 of its ownK113274 Footprint Ultra PK Suture AnchorSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK093925 Lifenet SystemPhysio-Control, Inc. · 2010
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc. · 2009 · cites it directly41descendants
- K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc. · 2012 · 2 generations on29descendants
- K093897Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · cites it directly29descendants
- K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc. · 2012 · 2 generations on16descendants
- K093925Lifenet SystemPhysio-Control, Inc. · 2010 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971723 | Fastak Suture Anchor (11.7MM)/(7.5MM) | Arthrex, Inc. | 1997 | — |
| −1 | K051219 | Pushlock | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K073509 | Twinfix PK FP Suture Anchor | Smith & Nephew, Inc. | 2008 | — |
| +1 | 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 | — |
| +1 | K093897 | Smith & Nephew Footprint Ultra PK Suture Anchor | Smith & Nephew Inc., Endoscopy Div. | 2010 | 2 |
| +2 | K113274 | Footprint Ultra PK Suture Anchor | Smith & Nephew, Inc. | 2012 | — |
| +1 | K093925 | Lifenet System | Physio-Control, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K051219 | PushlockSummary page 2…WINFIX PK FP Suture Anchor is substantially equivalent in design, materials, function and intended use to the Arthrex® PushLockTM suture anchor, cleared in K051219. The proposed and the predicate devices both have the same intended use, indications for use, anchor material. H. Summary… | 2005 |
What descends from it? (64)
See all 646 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 11 years and passes through 2 companies; a new generation was cleared every 7.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K093428 (Smith & Nephew Endoscopy, Inc., 2009) has gone furthest, with 41 descendants of its own.
- 13 other devices also cite its predicate K051219.
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 TWINFLX PK FP Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction. Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot…
Read the full statement (103 words)
The Smith & Nephew TWINFLX PK FP Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Illoiotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073509: Twinfix PK FP Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073509
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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