510(k) · Cleared

Cleared

Titan RC Tack

K994269510(k) SpecialCleared Jan 10, 200021-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

Innovasive Devices, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Jan 10, 2000 as substantially equivalent to K992377 (Innovasive Devices, Inc., 1999) after a 21-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jan 10, 2000
Review: 21 days
Class: Class II
Product code: MAI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K970089 (1997). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK970089 Innovasive 2.8MM and 3.5MM Roc LF Suture Bone FastenerInnovasive Devices, Inc. · 1997
1 generation backK992377 RC TackInnovasive Devices, Inc. · 1999
This deviceK994269 Titan RC TackInnovasive Devices, Inc. · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970089	Innovasive 2.8MM and 3.5MM Roc LF Suture Bone Fastener	Innovasive Devices, Inc.	1997	—
−1	K992377	RC Tack	Innovasive Devices, Inc.	1999	—
0 (this device)	K994269	Titan RC Tack	Innovasive Devices, Inc.	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K994269, 1997–2000Source: 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

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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
*	K992377	RC Tack Summary page 1 …Common Name: Bone Anchor Class: II Classification Name: “Single/Multiple Component Bone Fixation Appliances and Accessories” 3. PREDICATE DEVICE: Innovasive RC Tack (K992377) 4. DEVICE DESCRIPTION: The Titan RC Tack is a bioabsorbable implant intended for soft tissue reattachment to host bone in the s…	Innovasive Devices, Inc.	1999	—

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 3 years and passes through 1 company; a new generation was cleared every 2.5 years on median.
None of the 3 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 Titan RC Tack is intended for soft tissue to bone fixation for the following

indications:

SHOULDER

Repair of rotator cuff tears

Acromio-clavicular separation

Biceps tenodesis

Deltoid repair

KNEE

Extra-Capsular repairs

Reattachment of medial collateral ligament

Reattachment of lateral collateral ligament

Reattachment of posterior oblique ligament

Joint capsule closure

Patellar ligament and tendon avulsion repairs

Extra-capsular reconstruction

ITB tenodesis

ANKLE

Lateral and medial instability

Achilles tendon reconstruction and repair

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K994269 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994269: Titan RC Tack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994269

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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