510(k) · Cleared
ClearedArthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HWC Screw, Fixation, Bone
Cleared on Jun 29, 2007 as substantially equivalent to K061863 (Arthrex, Inc., 2006) after a 63-day review. Its family tree reaches back 4 generations to 1996. 227 later devices descend from it.
- Decided
- Jun 29, 2007
- Review
- 63 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961555 (1996). 5 ancestors in all. 227 later devices descend from it, 10 citing it directly.
- Root · 4 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 3 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 1 generation backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- This deviceK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- Descendant · cites it directly · 159 of its ownK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- Descendant · 2 generations on · 103 of its ownK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- Descendant · cites it directly · 100 of its ownK091844 Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009
- Descendant · 2 generations on · 77 of its ownK112237 Microsuture AnchorsArthrex, Inc. · 2011
- Descendant · 2 generations on · 64 of its ownK110660 Arthrex Biocomposite SuturetakArthrex, Inc. · 2011
Showing 5 of 227 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 227 · See all- K082810Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc. · 2009 · cites it directly159descendants
- K101823Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · 2 generations on103descendants
- K091844Arthrex Bio-Composite Suturetak AnchorsArthrex, Inc. · 2009 · cites it directly100descendants
- K112237Microsuture AnchorsArthrex, Inc. · 2011 · 2 generations on77descendants
- K110660Arthrex Biocomposite SuturetakArthrex, Inc. · 2011 · 2 generations on64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −3 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −2 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −1 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| 0 (this device) | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| +1 | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| +2 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| +1 | K091844 | Arthrex Bio-Composite Suturetak Anchors | Arthrex, Inc. | 2009 | — |
| +2 | K112237 | Microsuture Anchors | Arthrex, Inc. | 2011 | — |
| +2 | K110660 | Arthrex Biocomposite Suturetak | Arthrex, Inc. | 2011 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 8 | 0 |
| 2012 | 2 | 0 |
| 2013 | 8 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 11 | 0 |
| 2018 | 16 | 0 |
| 2019 | 16 | 0 |
| 2020 | 19 | 0 |
| 2021 | 11 | 0 |
| 2022 | 11 | 0 |
| 2023 | 31 | 0 |
| 2024 | 16 | 0 |
| 2025 | 25 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…ple, fixation, bone MAI - Fastener, Fixation, Biodegradable, Soft Tissue Predicate Device Arthrex PushLock, Tak and Corkscrew Suture Anchors: K061863 Deidce Description The Arthrex Bio-Composite Suture Anchors Family isvery similar to andIntendW Use the predicate device… | 2006 |
What descends from it? (227)
See all 22710 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak… | 2009 | 159 |
| K091844 | Arthrex Bio-Composite Suturetak Anchors | 2009 | 100 |
| K073412 | Gryphon BR and Healix BR Anchors | 2008 | 44 |
| K162429 | ZipE Knotless Tissue Repair and Attachment Devices | 2017 | 5 |
| K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor | 2019 | 2 |
| K182941 | HEALIX ADVANCE SP PEEK Anchor | 2019 | 2 |
| K171114 | HEALIX ADVANCE KNOTLESS Anchor | 2017 | 2 |
| K133235 | Threaded Peek K-Wire | 2014 | 2 |
| K180101 | HEALIX ADVANCE KNOTLESS BR Anchor | 2018 | 1 |
| K122635 | Tornier Insite FT Biocomposite Suture Anchor | 2013 | 0 |
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 5 ancestors have a recall of any class.
- Of its descendants, K082810 (Arthrex, Inc., 2009) has gone furthest, with 159 descendants of its own.
- 33 other devices also cite its predicate K061863.
How does its category compare?
All HWC devicesHWC Screw, 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 · 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 Arthrex Bio-Composite Corkscrew is Intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization…
Read the full statement (467 words)
The Arthrex Bio-Composite Corkscrew is Intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite PushLock is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite Tak is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, shoulder, elbow, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:
Skull: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, Soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and periorbital bones of the skull.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071177 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071177: Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak, Bio-Composite Corkscrew.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071177
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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