510(k) · Cleared
ClearedStryker Peek Twinloop Tac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jul 20, 2007 as substantially equivalent to K971723 (Arthrex, Inc., 1997) and 4 other predicates after a 112-day review. Its family tree reaches back 4 generations to 1996. 35 later devices descend from it.
- Decided
- Jul 20, 2007
- Review
- 112 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K961555 (1996). 11 ancestors in all. 35 later devices descend from it, 3 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 deviceK070882 Stryker Peek Twinloop TacStryker Endoscopy · 2007
- Descendant · cites it directly · 27 of its ownK120509 Stryker All Suture AnchorsStryker · 2012
- Descendant · 2 generations on · 25 of its ownK133671 Iconix All Suture AnchorsStryker Corp. · 2014
- Descendant · 3 generations on · 10 of its ownK151201 Stryker ICONIX with NeedlesStryker · 2015
- Descendant · 4 generations on · 5 of its ownK173074 ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018
- Descendant · 5 generations on · 3 of its ownK231078 All-Suture AnchorRiverpoint Medical, LLC · 2023
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K120509Stryker All Suture AnchorsStryker · 2012 · cites it directly27descendants
- K133671Iconix All Suture AnchorsStryker Corp. · 2014 · 2 generations on25descendants
- K151201Stryker ICONIX with NeedlesStryker · 2015 · 3 generations on10descendants
- K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker · 2018 · 4 generations on5descendants
- K231078All-Suture AnchorRiverpoint Medical, LLC · 2023 · 5 generations on3descendants
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) | K070882 | Stryker Peek Twinloop Tac | Stryker Endoscopy | 2007 | — |
| +1 | K120509 | Stryker All Suture Anchors | Stryker | 2012 | — |
| +2 | K133671 | Iconix All Suture Anchors | Stryker Corp. | 2014 | — |
| +3 | K151201 | Stryker ICONIX with Needles | Stryker | 2015 | — |
| +4 | K173074 | ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor | Stryker | 2018 | — |
| +5 | K231078 | All-Suture Anchor | Riverpoint Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 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? (5)
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 |
|---|---|---|---|
| * | K971723 | Fastak Suture Anchor (11.7MM)/(7.5MM)Summary page 1…21 CFR 888.3040, Product Code MBI, Orthopedics Review Panel) Predicate Device(s): Arthrex PEEK SutureTak: K971723, K000506, K050749, K061863 Arthrex Bio-Corkscrew FT: K043337 Device Description and Intended Use: Th… | 1997 |
| * | K000506 | Bio-Fastak Suture Anchor, Model AR-1324BSummary page 1…8.3040, Product Code MBI, Orthopedics Review Panel) Predicate Device(s): Arthrex PEEK SutureTak: K971723, K000506, K050749, K061863 Arthrex Bio-Corkscrew FT: K043337 Device Description and Intended Use: The Stryker… | 2000 |
| * | K050749 | Arthrex Tak FamilySummary page 1…roduct Code MBI, Orthopedics Review Panel) Predicate Device(s): Arthrex PEEK SutureTak: K971723, K000506, K050749, K061863 Arthrex Bio-Corkscrew FT: K043337 Device Description and Intended Use: The Stryker PEEK Twi… | 2005 |
| * | K061863 | Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilySummary page 1…de MBI, Orthopedics Review Panel) Predicate Device(s): Arthrex PEEK SutureTak: K971723, K000506, K050749, K061863 Arthrex Bio-Corkscrew FT: K043337 Device Description and Intended Use: The Stryker PEEK TwinLoop Tac… | 2006 |
| * | K043337 | Arthrex Bio-Corkscrew FT Suture AnchorSummary page 1…Orthopedics Review Panel) Predicate Device(s): Arthrex PEEK SutureTak: K971723, K000506, K050749, K061863 Arthrex Bio-Corkscrew FT: K043337 Device Description and Intended Use: The Stryker PEEK TwinLoop Tac is intended to be used for suture or tissu… | 2004 |
What descends from it? (35)
See all 353 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 4 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K120509 (Stryker, 2012) has gone furthest, with 27 descendants of its own.
- 6 other devices also cite its predicate K971723.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Stryker PEEK TwinLoop Tac is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs: Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair…
Read the full statement (169 words)
The Stryker PEEK TwinLoop Tac is intended to be used for suture or tissue fixation in the foot, ankle, knee, hip, hand, wrist, elbow, and shoulder. Specific indications are listed below and are size appropriate per patient needs:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Hand/Wrist: Scaphulolunate 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.
Hip: Capsular repair, acetabular labral repair.
The Stryker PEEK TwinLoop Tac is intended for single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070882: Stryker Peek Twinloop Tac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070882
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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