510(k) · Cleared

Cleared

Stryker Biozip Suture Anchor

K023192510(k) TraditionalCleared Mar 20, 2003176-day reviewClass II21 CFR 888.3040

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

Stryker Endoscopy · HWC Screw, Fixation, Bone

Cleared on Mar 20, 2003 as substantially equivalent to K990987 (Arthrex, Inc., 2000) after a 176-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.

Decided: Mar 20, 2003
Review: 176 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K990987 (2000). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK990987 Bio-Absorbable Corkscrew, Model AR-1920BArthrex, Inc. · 2000
This deviceK023192 Stryker Biozip Suture AnchorStryker Endoscopy · 2003
Descendant · cites it directly · 3 of its ownK041305 Stryker Biozip Suture Anchor SystemStryker Endoscopy · 2004
Descendant · cites it directly · 2 of its ownK070758 Stryker Peek Zip Suture AnchorStryker Endoscopy · 2007
Descendant · 2 generations on · 0 of its ownK180759 SECULOK™ Suture AnchorU&I Corporation · 2018
Descendant · 2 generations on · 0 of its ownK142643 Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc. · 2014

Most influential descendants

Showing 4 of 4 · See all

K041305Stryker Biozip Suture Anchor SystemStryker Endoscopy · 2004 · cites it directly3descendants
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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990987	Bio-Absorbable Corkscrew, Model AR-1920B	Arthrex, Inc.	2000	—
0 (this device)	K023192	Stryker Biozip Suture Anchor	Stryker Endoscopy	2003	—
+1	K041305	Stryker Biozip Suture Anchor System	Stryker Endoscopy	2004	—
+1	K070758	Stryker Peek Zip Suture Anchor	Stryker Endoscopy	2007	—
+2	K180759	SECULOK™ Suture Anchor	U&I Corporation	2018	—
+2	K142643	Stabilynx PEEK Suture Anchor	D3 Dc, LLC /Stabilynx, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0
2014	1	0
2018	1	0

FIG. 1 — Lineage of K023192, 2000–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K990987	Bio-Absorbable Corkscrew, Model AR-1920B Summary page 1 …Bioabsorbable Suture Anchor Proprietary Name: Stryker BioZip Suture Anchor Predicate Device Arthrex 5 .O mm Bio-Corkscrew Suture Anchor (#K990987) currently marketed by Arthrex, Inc. (Naples, FL). Summary This summary of 5 1O(k) safety and effectiveness is being submitted i…	Arthrex, Inc.	2000	—

Also cleared against K990987: 3 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041305	Stryker Biozip Suture Anchor System	Stryker Endoscopy	2004	3
K070758	Stryker Peek Zip Suture Anchor	Stryker Endoscopy	2007	2

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?

Its one ancestor has no recall.
Of its descendants, K041305 (Stryker Endoscopy, 2004) has gone furthest, with 3 descendants of its own.
3 other devices also cite its predicate K990987.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)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 Stryker BioZip Suture Anchor is a soft tissue anchor that will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: Elbow, Wrist, Hand: Rotator Cuff Repair Scapholunate Ligament Reconstruction Bankart Repair Ulnar Collateral Ligament Reconstruction SLAP Lesion Repair Radial Collateral Ligament Reconstruction Acromio-Clavicular Separation Repair Biceps Tendon Reattachment.…

Read the full statement (121 words)

The Stryker BioZip Suture Anchor is a soft tissue anchor that will be used to secure soft tissue to

bone during reconstructive surgery. The anchor is intended for use in such procedures as:

Shoulder: Elbow, Wrist, Hand:

Rotator Cuff Repair Scapholunate Ligament Reconstruction

Bankart Repair Ulnar Collateral Ligament Reconstruction

SLAP Lesion Repair Radial Collateral Ligament Reconstruction

Acromio-Clavicular Separation Repair Biceps Tendon Reattachment.

Capsular ShifVCapsulolabral Reconstruction

Biceps Tenodesis Foot and Ankle:

Deltoid Repair. Medial Instability RepairReconstruction

Lateral Instability RepairReconstruction

Knee: Achilles Tendon Repair/Reconstruction

Extra Capsular Repairs Midfoot Reconstruction

Medial Collateral Ligament Hallux Valgus Reconstruction.

Lateral Collateral Ligament

Posterior Oblique Ligament Pelvis: Bladder Neck Suspension Procedures.

Illiotibial Band Tenodesis

Patellar Tendon Repair. '

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023192 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023192: Stryker Biozip 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/K023192

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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