510(k) Report

510(k) · Cleared

Cleared

Stryker Biozip Suture Anchor System

K041305510(k) SpecialCleared Jun 14, 200428-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stryker Endoscopy · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jun 14, 2004 as substantially equivalent to K023192 (Stryker Endoscopy, 2003) after a 28-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.

Decided
Jun 14, 2004
Review
28 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K990987 (2000). 3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2018: 1 descendant cleared2014: 1 descendant clearedK990987 · Bio-Absorbable Corkscrew, Model AR-1920B · Arthrex, Inc. · 2000K023192 · Stryker Biozip Suture Anchor · Stryker Endoscopy · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants K023192 · Stryker Biozip Suture Anchor · Stryker Endoscopy · 2003K990987 · Bio-Absorbable Corkscrew, Model AR-1920B · Arthrex, Inc. · 20000
  1. Root · 2 generations backK990987 Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc. · 2000
  2. 1 generation backK023192 Stryker Biozip Suture AnchorStryker Endoscopy · 2003
  3. This deviceK041305 Stryker Biozip Suture Anchor SystemStryker Endoscopy · 2004
  4. Descendant · cites it directly · 2 of its ownK070758 Stryker Peek Zip Suture AnchorStryker Endoscopy · 2007
  5. Descendant · 2 generations on · 0 of its ownK180759 SECULOK™ Suture AnchorU&I Corporation · 2018
  6. Descendant · 2 generations on · 0 of its ownK142643 Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc. · 2014

Most influential descendants

Showing 3 of 3 · See all
  • K070758Stryker Peek Zip Suture AnchorStryker Endoscopy · 2007 · cites it directly2descendants
  • K180759SECULOK™ Suture AnchorU&I Corporation · 2018 · 2 generations on0descendants
  • K142643Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K990987Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc.2000—
−1K023192Stryker Biozip Suture AnchorStryker Endoscopy2003—
0 (this device)K041305Stryker Biozip Suture Anchor SystemStryker Endoscopy2004—
+1K070758Stryker Peek Zip Suture AnchorStryker Endoscopy2007—
+2K180759SECULOK™ Suture AnchorU&I Corporation2018—
+2K142643Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201410
201810
FIG. 1 — Lineage of K041305, 2000–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K023192Stryker Biozip Suture Anchor
Summary page 1
…the predicate device. The line extension of the Stryker BioZip Suture Anchor System is considered substantially equivalent to the Stryker BioZip Suture Anchor System (#K023 192). Contact: Date: May 7. 2004 Melissa Murphy Regulatory Repres…
Stryker Endoscopy2003—

Also cleared against K023192: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070758Stryker Peek Zip Suture AnchorStryker Endoscopy20072

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 4 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K070758 (Stryker Endoscopy, 2007) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K023192.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

The Styker BioZip Suture Anchor System is intended for use in securing soft tissue to bone in such procedures as: Shoulder: Rotator cuff repair Bankart repair SLAP lesion repair Acromio-clavicular sepaeration 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…

Read the full statement (108 words)

The Styker BioZip Suture Anchor System is intended for use in securing soft tissue to bone in such procedures as:

Shoulder:

Rotator cuff repair

Bankart repair

SLAP lesion repair

Acromio-clavicular sepaeration 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 & Ankle

Medial instability repair/reconstruction

Lateral instability repair/reconstruction

Achilles tendon repair/reconstruction

Midfoot reconstruction

Hallux valgus reconstruction

Knee:

Extra capsular repairs

Medial collateral ligament

Lateral collateral ligament

Posterior oblique ligament

Illiotibial band tenosis

Patellar tendon repair

Pelvis:

Bladder neck suspension procedures

The Stryker BioZip Suture Anchor System is intended for single-use only.

Indications for use as stated in the FDA summary.

Also cleared against K023192

1 other device cites the same predicate.

  • K070758Stryker Peek Zip Suture AnchorStryker Endoscopy · 2007

More from Stryker Endoscopy

103 FDA decisions under this applicant name. See the company

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Recent decisions in MAI

The MAI category page

  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K041305 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041305: Stryker Biozip Suture Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041305

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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