510(k) · Cleared
ClearedArthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Jan 23, 2009 as substantially equivalent to K071177 (Arthrex, Inc., 2007) after a 121-day review. Its family tree reaches back 5 generations to 1996. 159 later devices descend from it.
- Decided
- Jan 23, 2009
- Review
- 121 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K961555 (1996). 6 ancestors in all. 159 later devices descend from it, 13 citing it directly.
- Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
- 4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
- 2 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
- 1 generation backK071177 Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock…Arthrex, Inc. · 2007
- This deviceK082810 Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite…Arthrex, Inc. · 2009
- Descendant · cites it directly · 103 of its ownK101823 Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · Recalled
- Descendant · cites it directly · 41 of its ownK101679 Arthrex Pushlock AnchorsArthrex, Inc. · 2010
- Descendant · 2 generations on · 40 of its ownK110545 Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor…Smith & Nephew, Inc. · 2011
- 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
Showing 5 of 159 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 159 · See all- K101823Arthrex Swivelock AnchorsArthrex, Inc. · 2011 · cites it directly103descendants
- K101679Arthrex Pushlock AnchorsArthrex, Inc. · 2010 · cites it directly41descendants
- K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc. · 2011 · 2 generations on40descendants
- K151342Arthrex SwiveLock AnchorsArthrex, Inc. · 2016 · 2 generations on38descendants
- K171141Arthrex SwiveLock AnchorsArthrex, Inc. · 2017 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961555 | Acufex Tag Bioabsorbable Anchors | Acufex Microsurgical, Inc. | 1996 | — |
| −4 | K031685 | Tag Rod Bioraptor Suture Anchor 7209317, 7209318 | Smith & Nephew, Inc. | 2003 | 5 |
| −3 | K053344 | Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture… | Smith & Nephew, Inc. | 2006 | — |
| −2 | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family | Arthrex, Inc. | 2006 | — |
| −1 | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite… | Arthrex, Inc. | 2007 | — |
| 0 (this device) | K082810 | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock… | Arthrex, Inc. | 2009 | — |
| +1 | K101823 | Arthrex Swivelock Anchors | Arthrex, Inc. | 2011 | 6 |
| +1 | K101679 | Arthrex Pushlock Anchors | Arthrex, Inc. | 2010 | — |
| +2 | K110545 | Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK) | Smith & Nephew, Inc. | 2011 | — |
| +2 | K151342 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2016 | — |
| +3 | K171141 | Arthrex SwiveLock Anchors | Arthrex, Inc. | 2017 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 8 | 0 |
| 2018 | 13 | 0 |
| 2019 | 11 | 0 |
| 2020 | 9 | 0 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 21 | 0 |
| 2024 | 14 | 0 |
| 2025 | 21 | 0 |
| 2026 | 20 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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 |
|---|---|---|---|
| * | K071177 | Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Summary page 1…JDR - Staple, fixaton, bone MAI - Fastener, Fixation, Biodegradable, Soft Tissue Predicate Device Arlhrex Bio-Composie Suture Anchors K071177 Dewce Descnption The Arthrex Bio-Composte Suture Anchors Family isidentical to the and Intended Use predicate devices The… | 2007 |
What descends from it? (159)
See all 15913 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101823 | Arthrex Swivelock Anchors | 2011 | 103 |
| K101679 | Arthrex Pushlock Anchors | 2010 | 41 |
| K102298 | Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor… | 2011 | 15 |
| K173788 | Arthrex Corkscrew FT | 2018 | 5 |
| K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor | 2019 | 2 |
| K182941 | HEALIX ADVANCE SP PEEK Anchor | 2019 | 2 |
| K170868 | FIXIT Threaded Anchor System | 2017 | 2 |
| K171114 | HEALIX ADVANCE KNOTLESS Anchor | 2017 | 2 |
| K133235 | Threaded Peek K-Wire | 2014 | 2 |
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | 2026 | 1 |
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 13 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K101823 (Arthrex, Inc., 2011) has gone furthest, with 103 descendants of its own.
- 9 other devices also cite its predicate K071177.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Arthrex Bio-Composite PushLockTm is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, lup, 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 Stabtization, Medial Stabiliation, Achilles Tendon Repair…
Read the full statement (487 words)
The Arthrex Bio-Composite PushLockTm is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, lup, 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 Stabtization, Medial Stabiliation, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bumonectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Obhque Ligament Repair, lhotibial Band Tenodesis
HandlWrts 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
Pe/s- Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Hip, Capsular Repair, acetabular labral repair
The Arthrex Bio-Composite Corkscrew is intended for fixation of suture (soft issue) to bone in the shoulder, foot/anilde, hip, knee, hand/wrist, elbow, and pelvis in,but not lmiuted 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 Stabihzation, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repar/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Ihotibial Band Tenodesis
Hand/Wrst Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Tennus Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondyhtis Repair
Pelvi: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Hqp: Capsular Repair, acetabular labral repair
The Arthrex Bio-Composite TakTm is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, shoulder, elbow, and m select maxillofacial apphcations Specific indications are listed below and are size appropriate per patient needs
Skull: Stabilization and fixation of oral cramo-maxillofacial skeletal bone, mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift; Temporomandibular Joint (CMi) reconstruction, Soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and penoorbital 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, Acrormo-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Hand/Wrst 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, Ihotibial Band Tenodesis
Pelvt: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency
Hip: Capsular Repair, acetabular labral repair
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082810: Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite Pushlock, Bio-Composite Tak and Bio-Composite Corkscrew.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082810
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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