510(k) · Cleared

Cleared

Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006

K101184510(k) SpecialCleared May 18, 201020-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

Arthrocare Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on May 18, 2010 as substantially equivalent to K092133 (Arthrocare Corp., 2009) after a 20-day review. Its family tree reaches back 5 generations to 1996. 4 later devices descend from it.

Decided: May 18, 2010
Review: 20 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K961555 (1996). 14 ancestors in all. 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 5 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
4 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
3 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
2 generations backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
1 generation backK092133 Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065…Arthrocare Corp. · 2009
This deviceK101184 Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065…Arthrocare Corp. · 2010
Descendant · cites it directly · 2 of its ownK102262 Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction…Arthrocare Corp. · 2010
Descendant · 2 generations on · 1 of its ownK110164 5.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap…Arthrocare Corp. · 2011
Descendant · cites it directly · 0 of its ownK111397 Titan TI Suture Anchor SystemArthrocare Corp. · 2011
Descendant · 2 generations on · 0 of its ownK110781 5.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with…Arthrocare Corp. · 2011

Most influential descendants

Showing 4 of 4 · See all

K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp. · 2010 · cites it directly2descendants
K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp. · 2011 · 2 generations on1descendant
K111397Titan TI Suture Anchor SystemArthrocare Corp. · 2011 · cites it directly0descendants
K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp. · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−4	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−3	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−2	K061863	Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family	Arthrex, Inc.	2006	—
−1	K092133	Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065N	Arthrocare Corp.	2009	—
0 (this device)	K101184	Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N…	Arthrocare Corp.	2010	—
+1	K102262	Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction Tool	Arthrocare Corp.	2010	—
+2	K110164	5.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction Tool	Arthrocare Corp.	2011	—
+1	K111397	Titan TI Suture Anchor System	Arthrocare Corp.	2011	—
+2	K110781	5.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles…	Arthrocare Corp.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
2000	1	0
2001	2	0
2004	1	0
2005	1	0
2006	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	3	0

FIG. 1 — Lineage of K101184, 1996–2011Source: 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

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
*	K092133	Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065N Summary page 1 …Class II, 21 CFR 888.3040 Product Code MBI and HWC Predicate Devices Arthrocare Titan Ti Suture Anchor K092133 (November 5, 2009) Product Description The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corksc…	Arthrocare Corp.	2009	—

Also cleared against K092133: 2 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
K102262	Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction Tool	Arthrocare Corp.	2010	2
K111397	Titan TI Suture Anchor System	Arthrocare Corp.	2011	0

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 14 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
2 of the 14 ancestors have a recall of any class.
Of its descendants, K102262 (Arthrocare Corp., 2010) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K092133.

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. 2010, 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?

The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures: * Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, Acromio-Clavicular Sepdration Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; * Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux…

Read the full statement (130 words)

The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:

* Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, Acromio-Clavicular Sepdration Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

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

* Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;

* Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction;

• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;

* Hip: Capsular Repair, Acetabular Labral Repair

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101184 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101184: Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101184

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