510(k) · Cleared

Cleared

Innovasive 2.8MM and 3.5MM Roc LF Suture Bone Fastener

K970089510(k) TraditionalCleared Mar 25, 199774-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

Innovasive Devices, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Mar 25, 1997 after a 74-day review. The FDA summary names its predicate without a number. 82 later devices descend from it.

Decided: Mar 25, 1997
Review: 74 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 0

82 later devices descend from it, 2 citing it directly.

This deviceK970089 Innovasive 2.8MM and 3.5MM Roc LF Suture Bone FastenerInnovasive Devices, Inc. · 1997
Descendant · cites it directly · 79 of its ownK992458 RC Multisuture Bone Anchor, Model 4453/4454Innovasive Devices, Inc. · 1999
Descendant · 2 generations on · 78 of its ownK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
Descendant · 2 generations on · 77 of its ownK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
Descendant · 3 generations on · 76 of its ownK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
Descendant · 3 generations on · 75 of its ownK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006

Showing 5 of 82 descendants. See all descendants

Descendants cleared per year

1999high 8 (2023) · low 0 (2001)2026

Most influential descendants

Showing 5 of 82 · See all

K992458RC Multisuture Bone Anchor, Model 4453/4454Innovasive Devices, Inc. · 1999 · cites it directly79descendants
K020056Duet Suture AnchorBionx Implants, Ltd. · 2002 · 2 generations on78descendants
K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003 · 2 generations on77descendants
K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd. · 2004 · 3 generations on76descendants
K053561Bio-Mini Revo Suture AnchorConmed Linvatec · 2006 · 3 generations on75descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970089	Innovasive 2.8MM and 3.5MM Roc LF Suture Bone Fastener	Innovasive Devices, Inc.	1997	—
+1	K992458	RC Multisuture Bone Anchor, Model 4453/4454	Innovasive Devices, Inc.	1999	—
+2	K020056	Duet Suture Anchor	Bionx Implants, Ltd.	2002	—
+2	K030388	Impact Suture Anchor. Model 433510	Bionx Implants, Ltd.	2003	—
+3	K042966	Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models…	Linvatec Biomaterials, Ltd.	2004	—
+3	K053561	Bio-Mini Revo Suture Anchor	Conmed Linvatec	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2000	1	0
2002	1	0
2003	1	0
2004	1	0
2006	1	0
2008	1	0
2009	6	0
2010	3	0
2011	3	0
2012	2	0
2013	3	0
2014	3	0
2015	2	0
2016	1	0
2017	7	0
2018	4	0
2019	6	0
2020	5	0
2021	4	0
2022	4	0
2023	8	0
2024	3	0
2025	8	0
2026	2	0

FIG. 1 — Lineage of K970089, 1997–2026Source: 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? (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
*	—	Innovasive Devices ROC Suture Bone Fastener Named without a submission number			—

What descends from it? (82)

See all 82

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

Number	Device	Applicant	Decided	Descendants
K992458	RC Multisuture Bone Anchor, Model 4453/4454	Innovasive Devices, Inc.	1999	79
K992377	RC Tack	Innovasive Devices, Inc.	1999	1

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?

Of its descendants, K992458 (Innovasive Devices, Inc., 1999) has gone furthest, with 79 descendants of its own.

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.

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 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER 1. Repair of rotator cuff tears 2. capsular instability 3. slap lesion repair 4. acromio-clavicular separation 5. capsule shift/capsulolabral reconstruction 6. biceps tenodesis 7. deltoid repair KNEE 1. Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament…

Read the full statement (117 words)

The 2.8mm and 3.5mm ROC LF Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:

SHOULDER

1. Repair of rotator cuff tears

2. capsular instability

3. slap lesion repair

4. acromio-clavicular separation

5. capsule shift/capsulolabral reconstruction

6. biceps tenodesis

7. deltoid repair

KNEE

1. Extra-capsular repairs, and reattachment of medial collateral ligament, lateral collateral ligament, posterior oblique ligament, joint capsule closure.

2. Patellar ligament and tendon avulsion repairs.

3. Extra-capsular reconstruction, ITB tenodesis

ANKLE

1. Lateral instability

2. Medial instability

3. Achilles tendon reconstruction and repair

4. Mid-foot reconstructions

FOOT

1. Hallux valgus reconstruction

BLADDER NECK SUSPENSION

1. Bladder neck suspension for female urinary incontinence due to urethral hypermobility.

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/K970089 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970089: Innovasive 2.8MM and 3.5MM Roc LF Suture Bone Fastener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970089

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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