510(k) · Cleared

Cleared

Modification to Stryker Xcel Anchor System

K041307510(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 K023013 (Stryker Endoscopy, 2003) after a 28-day review. Its family tree reaches back 2 generations to 1997.

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 K970896 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK970896 Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor SystemETHICON, Inc. · 1997
1 generation backK023013 Stryker Xcel Anchor SystemStryker Endoscopy · 2003
This deviceK041307 Modification to Stryker Xcel Anchor SystemStryker Endoscopy · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970896	Mitek 3.5 MM Panalok Wedge Absorbable Suture Anchor System	ETHICON, Inc.	1997	—
−1	K023013	Stryker Xcel Anchor System	Stryker Endoscopy	2003	—
0 (this device)	K041307	Modification to Stryker Xcel Anchor System	Stryker Endoscopy	2004	—

FIG. 1 — Lineage of K041307, 1997–2004Source: 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 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

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
*	K023013	Stryker Xcel Anchor System Summary page 1 …l Name: Bioabsorbable Suture Anchor (MAI) ProprietaryName: Stryker XCEL Anchor System Predicate Device Stryker XCEL Anchor System (#K0230 13), currently marketed by Stryker Endoscopy (San Jose, CA). Summary This summary of Special 5 10(k) safety and effectiveness is bei…	Stryker Endoscopy	2003	—

What descends from it?

No later submission names this one as a predicate yet.

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 5.7 years on median.
None of the 2 ancestors has a recall.

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

2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007high 191 (2016) · low 34 (2023)2026

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

Recalls per year · MAI

40in 2020

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

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

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 Stryker XCEL Anchor System is intended for use in securing soft tissue to bone in such procedures as: Shoulder: Bankart repair SLAP lesion repair Rotator cuff repair Capsular shift repair Biceps tenodesis Acromio-clavicular separation Elbow: Biceps tendon reattachment Foot & Ankle: Achilles tendon repair/reconstruction Lateral stabilization Medial stabilization Knee: Medial collateral ligament repair Lateral collateral ligament repair Joint capsule…

Read the full statement (94 words)

The Stryker XCEL Anchor System is intended for use in securing soft tissue to bone in such procedures as:

Shoulder:

Bankart repair

SLAP lesion repair

Rotator cuff repair

Capsular shift repair

Biceps tenodesis

Acromio-clavicular separation

Elbow:

Biceps tendon reattachment

Foot & Ankle:

Achilles tendon repair/reconstruction

Lateral stabilization

Medial stabilization

Knee:

Medial collateral ligament repair

Lateral collateral ligament repair

Joint capsule closure to anterior proximal tibia

Posterior oblique ligament or joint capsule to tibia repair

Extra capsular reconstruction/ITB tenodesis

Patellar ligament and tendon avulsion repairs

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041307 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041307: Modification to Stryker Xcel 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/K041307

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