510(k) · Cleared

Cleared

Bonutti Anchor

K934183510(k) TraditionalCleared Apr 3, 1996951-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

Apogee Medical Products, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Apr 3, 1996 after a 951-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 396 later devices descend from it.

Decided: Apr 3, 1996
Review: 951 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 0

396 later devices descend from it, 3 citing it directly.

This deviceK934183 Bonutti AnchorApogee Medical Products, Inc. · 1996
Descendant · cites it directly · 393 of its ownK973015 Multitak SS Suture SystemBonutti Research · 1997
Descendant · 2 generations on · 336 of its ownK990156 Multitak SS ButtonsBonutti Research · 1999
Descendant · 3 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
Descendant · 4 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
Descendant · 5 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005

Showing 5 of 396 descendants. See all descendants

Descendants cleared per year

1997high 40 (2026) · low 0 (1998)2026

Most influential descendants

Showing 5 of 396 · See all

K973015Multitak SS Suture SystemBonutti Research · 1997 · cites it directly393descendants
K990156Multitak SS ButtonsBonutti Research · 1999 · 2 generations on336descendants
K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · 3 generations on309descendants
K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 4 generations on306descendants
K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 5 generations on217descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K934183	Bonutti Anchor	Apogee Medical Products, Inc.	1996	—
+1	K973015	Multitak SS Suture System	Bonutti Research	1997	—
+2	K990156	Multitak SS Buttons	Bonutti Research	1999	—
+3	K033717	Transet Fracture Fixation System	Bonutti Research, Inc.	2004	—
+4	K043248	Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…	Arthrex, Inc.	2005	—
+5	K052776	Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…	Arthrex, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
1999	2	0
2001	1	0
2003	1	0
2004	2	0
2005	3	0
2006	4	0
2007	3	0
2008	6	0
2009	4	0
2010	2	0
2011	9	0
2012	5	0
2013	16	0
2014	19	0
2015	11	0
2016	10	0
2017	22	0
2018	17	0
2019	30	0
2020	30	0
2021	28	0
2022	26	0
2023	32	0
2024	36	0
2025	34	0
2026	40	0

FIG. 1 — Lineage of K934183, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (396)

See all 396

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

Number	Device	Applicant	Decided	Descendants
K973015	Multitak SS Suture System	Bonutti Research	1997	393
K971144	Multitak SS Suture System	Bonutti Research	1997	0
K964324	Multitak SS Suture System	Bonutti Research	1997	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?

Of its descendants, K973015 (Bonutti Research, 1997) has gone furthest, with 393 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	—

https://510kreport.com/device/K934183 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934183: Bonutti Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934183

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026