510(k) · Cleared

Cleared

AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor

K213110510(k) TraditionalCleared Dec 16, 2022448-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

Auxein Medical Private Limited · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Dec 16, 2022 as substantially equivalent to K170327 (Parcus Medical, 2017) and 1 other predicate after a 448-day review. Its family tree reaches back 4 generations to 2002.

Decided: Dec 16, 2022
Review: 448 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K021883 (2002). 9 ancestors in all, the oldest K003227 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK021883 Biofastin RC Threaded Suture AnchorMitek Worldwide · 2002
3 generations backK041069 Spiralok AnchorDepuy Mitek, A Johnson & Johnson Company · 2004 · Recalled
2 generations backK071481 Healix AnchorDepuy Mitek, A Johnson & Johnson Company · 2007
1 generation backK120449 Healix Advance Peek AnchorDepuy Mitek · 2012
This deviceK213110 AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK…Auxein Medical Private Limited · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K021883	Biofastin RC Threaded Suture Anchor	Mitek Worldwide	2002	—
−3	K041069	Spiralok Anchor	Depuy Mitek, A Johnson & Johnson Company	2004	16
−2	K071481	Healix Anchor	Depuy Mitek, A Johnson & Johnson Company	2007	—
−1	K120449	Healix Advance Peek Anchor	Depuy Mitek	2012	—
0 (this device)	K213110	AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA…	Auxein Medical Private Limited	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2006	1	0
2012	2	0
2017	1	0

FIG. 1 — Lineage of K213110, 2002–2022Source: 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 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

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What was it cleared against? (2)

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
*	K170327	Parcus SLiK Anchors Summary page 6 …substantial equivalence: The following is the range of variants covered with their corresponding predicate devices. Primary Predicate: 510k Number K170327 Applicant Parcus Medical LLC. Common Name Suture Anchor Device Name…	Parcus Medical	2017	—
*	K120449	Healix Advance Peek Anchor Summary page 6 …Medical LLC. Common Name Suture Anchor Device Name Parcus SLiK Anchor Secondary Predicate: 510k Number K120449 Applicant Depuy Mitek Common Name Bone Anchor Device Name HEA…	Depuy Mitek	2012	—

Also cleared against K170327: 1 other device →

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 20 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
2 of the 9 ancestors have a recall of any class.
1 other device also cites its predicate K170327.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)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?

1. AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles…

Read the full statement (204 words)

1. AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor

The AUXILOCK® PEEK OPTIMA Screw-In Suture Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular Repair, Acetabular Labral Repair.

2. AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor

The AUXILOCK® ROTADOR PEEK OPTIMA Screw-In Anchor are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K213110 · printed Nov 6, 2026

Cite this page

510(k) Report. “K213110: AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213110

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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