510(k) · Cleared
ClearedStryker Peek Zip Suture Anchor
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 May 16, 2007 as substantially equivalent to K023192 (Stryker Endoscopy, 2003) and 2 other predicates after a 57-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- May 16, 2007
- Review
- 57 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K990987 (2000). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK990987 Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc. · 2000
- 2 generations backK023192 Stryker Biozip Suture AnchorStryker Endoscopy · 2003
- 1 generation backK041305 Stryker Biozip Suture Anchor SystemStryker Endoscopy · 2004
- This deviceK070758 Stryker Peek Zip Suture AnchorStryker Endoscopy · 2007
- Descendant · cites it directly · 0 of its ownK180759 SECULOK™ Suture AnchorU&I Corporation · 2018
- Descendant · cites it directly · 0 of its ownK142643 Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990987 | Bio-Absorbable Corkscrew, Model AR-1920B | Arthrex, Inc. | 2000 | — |
| −2 | K023192 | Stryker Biozip Suture Anchor | Stryker Endoscopy | 2003 | — |
| −1 | K041305 | Stryker Biozip Suture Anchor System | Stryker Endoscopy | 2004 | — |
| 0 (this device) | K070758 | Stryker Peek Zip Suture Anchor | Stryker Endoscopy | 2007 | — |
| +1 | K180759 | SECULOK™ Suture Anchor | U&I Corporation | 2018 | — |
| +1 | K142643 | Stabilynx PEEK Suture Anchor | D3 Dc, LLC /Stabilynx, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K023192 | Stryker Biozip Suture AnchorSummary page 1…uct Code MBI, Orthopedics Review Panel) Predicate Devices: Stryker 5.0mm BioZip Suture Anchor: # K023192, K041305 Arthrex 5.0mm PEEK Corkscrew FT: #K061665 Device Description and Intended Use: The Stryk… | 2003 |
| * | K041305 | Stryker Biozip Suture Anchor SystemSummary page 1…MBI, Orthopedics Review Panel) Predicate Devices: Stryker 5.0mm BioZip Suture Anchor: # K023192, K041305 Arthrex 5.0mm PEEK Corkscrew FT: #K061665 Device Description and Intended Use: The Stryker PEEK Z… | 2004 |
| * | K061665 | Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTSummary page 1…Orthopedics Review Panel) Predicate Devices: Stryker 5.0mm BioZip Suture Anchor: # K023192, K041305 Arthrex 5.0mm PEEK Corkscrew FT: #K061665 Device Description and Intended Use: The Stryker PEEK Zip Suture Anchor is a single-use, soft tissue anchor… | 2006 |
What descends from it? (2)
2 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 7 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K180759 (U&I Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023192.
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 Zip Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: * Rotator Cuff Repair * Bankart Repair * SLAP Lesion Repair * Acromio-Clavicular Separation Repair * Capsular Shift/Capsulolabral Reconstruction * Biceps Tenodesis * Deltoid Repair. Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction Ulnar Collateral…
Read the full statement (138 words)
The Stryker PEEK Zip Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder:
* Rotator Cuff Repair
* Bankart Repair
* SLAP Lesion Repair
* Acromio-Clavicular Separation Repair
* Capsular Shift/Capsulolabral Reconstruction
* Biceps Tenodesis
* Deltoid Repair.
Elbow, Wrist, Hand:
Scapholunate Ligament Reconstruction
Ulnar Collateral Ligament Reconstruction
Radial Collateral Ligament Reconstruction
Biceps Tendon Reattachment.
Foot and Ankle:
* Medial Instability Repair/Reconstruction
Lateral Instability Repair/Reconstruction
* Achilles Tendon Repair/Reconstruction
* Midfoot Reconstruction
Hallux Valgus Reconstruction.
Knee:
* Extra Capsular Repairs
o Medial Collateral Ligament
o Lateral Collateral Ligament
o Posterior Oblique Ligament
* Illiotibial Band Tenodesis
* Patellar Tendon Repair.
Pelvis:
Bladder Neck Suspension Procedures.
The Stryker PEEK Zip Suture Anchor is intended for single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070758: Stryker Peek Zip 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/K070758
Report an extraction error
Are you the manufacturer?
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