510(k) · Cleared

Cleared

Allthread Peek Anchor with Tantalum Marker

K071569510(k) SpecialCleared Jul 2, 200724-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

Biomet, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jul 2, 2007 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.

Decided: Jul 2, 2007
Review: 24 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 0

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

This deviceK071569 Allthread Peek Anchor with Tantalum MarkerBiomet, Inc. · 2007
Descendant · cites it directly · 7 of its ownK133036 Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · Recalled
Descendant · cites it directly · 6 of its ownK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · Recalled
Descendant · 2 generations on · 5 of its ownK142230 Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · Recalled
Descendant · 2 generations on · 2 of its ownK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011
Descendant · 3 generations on · 1 of its ownK192810 Apollo Suture Anchor SystemValeris Medical · 2020

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2008high 4 (2020) · low 0 (2009)2026

Most influential descendants

Showing 5 of 15 · See all

K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc. · 2014 · cites it directly7descendants
K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · cites it directly6descendants
K142230Apollo Suture Anchor System and Titan ScrewsValeris Medical · 2014 · 2 generations on5descendants
K110473Nanotack Suture Anchor 1.4MMPivot Medical · 2011 · 2 generations on2descendants
K192810Apollo Suture Anchor SystemValeris Medical · 2020 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K071569	Allthread Peek Anchor with Tantalum Marker	Biomet, Inc.	2007	—
+1	K133036	Apollo Suture Anchor System and Titan Screws	Amendia, Inc.	2014	1
+1	K080088	Biomet Sports Medicine Anchor Devices and Ziploop Constructs	Biomet Manufacturing, Inc.	2008	8
+2	K142230	Apollo Suture Anchor System and Titan Screws	Valeris Medical	2014	1
+2	K110473	Nanotack Suture Anchor 1.4MM	Pivot Medical	2011	—
+3	K192810	Apollo Suture Anchor System	Valeris Medical	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0
2013	3	0
2014	2	0
2015	2	0
2020	4	0
2023	2	0

FIG. 1 — Lineage of K071569, 2007–2023Source: 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? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K133036	Apollo Suture Anchor System and Titan Screws	Amendia, Inc.	2014	7
K080088	Biomet Sports Medicine Anchor Devices and Ziploop Constructs	Biomet Manufacturing, Inc.	2008	6

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, K133036 (Amendia, Inc., 2014) has gone furthest, with 7 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. 2007, 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	—

https://510kreport.com/device/K071569 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071569: Allthread Peek Anchor with Tantalum Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071569

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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