510(k) · Cleared

Cleared

Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065N

K092133510(k) TraditionalCleared Nov 5, 2009113-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. · HWC Screw, Fixation, Bone

Cleared on Nov 5, 2009 as substantially equivalent to K050358 (Arthrex, Inc., 2005) and 3 other predicates after a 113-day review. Its family tree reaches back 4 generations to 1996. 5 later devices descend from it.

Decided: Nov 5, 2009
Review: 113 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K961555 (1996). 13 ancestors in all. 5 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK961555 Acufex Tag Bioabsorbable AnchorsAcufex Microsurgical, Inc. · 1996
3 generations backK031685 Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc. · 2003 · Recalled
2 generations backK053344 Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5…Smith & Nephew, Inc. · 2006
1 generation backK061863 Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc. · 2006
This deviceK092133 Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065…Arthrocare Corp. · 2009
Descendant · cites it directly · 4 of its ownK101184 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 5 of 5 · See all

K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp. · 2010 · cites it directly4descendants
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
−4	K961555	Acufex Tag Bioabsorbable Anchors	Acufex Microsurgical, Inc.	1996	—
−3	K031685	Tag Rod Bioraptor Suture Anchor 7209317, 7209318	Smith & Nephew, Inc.	2003	5
−2	K053344	Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture…	Smith & Nephew, Inc.	2006	—
−1	K061863	Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family	Arthrex, Inc.	2006	—
0 (this device)	K092133	Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065N	Arthrocare Corp.	2009	—
+1	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	2	0
2011	3	0

FIG. 1 — Lineage of K092133, 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 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

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What was it cleared against? (4)

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
*	K050358	Artherx Corkscrew FT II Suture Anchor Summary page 1 …Class 11, 21 CFR 888.3040 Product Code MBI and HWC Predicate Devices Arthrex Corkscrew FT Suture Anchor K050358 cleared 04/15/05) Arthrex Corkscrew FT Suture Anchor K061665 (cleared 07/25/06) Arthrex Corkscrew FT III Suture Anchor…	Arthrex, Inc.	2005	—
*	K061665	Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT Summary page 1 …Product Code MBI and HWC Predicate Devices Arthrex Corkscrew FT Suture Anchor K050358 cleared 04/15/05) Arthrex Corkscrew FT Suture Anchor K061665 (cleared 07/25/06) Arthrex Corkscrew FT III Suture Anchor K062679 (cleared 09/27/06) Arthrex Corkscrew, Corkscrew FT, Bio-…	Arthrex, Inc.	2006	—
*	K062679	Arthrex Corkscrew FT Iii Suture Anchor with Three #2 Sutures Summary page 1 …orkscrew FT Suture Anchor K050358 cleared 04/15/05) Arthrex Corkscrew FT Suture Anchor K061665 (cleared 07/25/06) Arthrex Corkscrew FT III Suture Anchor K062679 (cleared 09/27/06) Arthrex Corkscrew, Corkscrew FT, Bio- K061863 (cleared 10/19/06) Corkscrew, and Bio Corkscrew FT Suture An…	Arthrex, Inc.	2006	—
*	K061863	Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family Summary page 1 …rkscrew FT Suture Anchor K061665 (cleared 07/25/06) Arthrex Corkscrew FT III Suture Anchor K062679 (cleared 09/27/06) Arthrex Corkscrew, Corkscrew FT, Bio- K061863 (cleared 10/19/06) Corkscrew, and Bio Corkscrew FT Suture Anchor(s) Product Description The Titan Ti Suture Anchor is a fully-th…	Arthrex, Inc.	2006	—

Also cleared against K050358: 4 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K101184	Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…	Arthrocare Corp.	2010	4
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 13 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
2 of the 13 ancestors have a recall of any class.
Of its descendants, K101184 (Arthrocare Corp., 2010) has gone furthest, with 4 descendants of its own.
4 other devices also cite its predicate K050358.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 Titan Ti Suture 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 Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux…

Read the full statement (125 words)

The Titan Ti Suture 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 Separation 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/K092133 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092133: Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092133

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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