510(k) · Cleared

Cleared

TI - Screw Anchor SP

K042460510(k) TraditionalCleared Oct 29, 200449-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

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

Cleared on Oct 29, 2004 as substantially equivalent to K012503 (Biomet Manufacturing, Inc., 2001) and 1 other predicate after a 49-day review. Its family tree reaches back 2 generations to 1995. 7 later devices descend from it.

Decided: Oct 29, 2004
Review: 49 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K943806 (1995). 3 ancestors in all. 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
1 generation backK012503 Metal Screw AnchorBiomet Manufacturing, Inc. · 2001
This deviceK042460 TI - Screw Anchor SPArthrotek, Inc. · 2004
Descendant · cites it directly · 6 of its ownK080088 Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · Recalled
Descendant · 2 generations on · 2 of its ownK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011
Descendant · 2 generations on · 0 of its ownK193402 ALLthread PEEK Suture AnchorBiomet, Inc. · 2020
Descendant · cites it directly · 0 of its ownK192942 ALLthread Titanium Suture AnchorBiomet, Inc. · 2020
Descendant · 2 generations on · 0 of its ownK123485 Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors…Biomet Sports Medicine · 2013 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008high 3 (2013) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all

K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · cites it directly6descendants
K110473Nanotack Suture Anchor 1.4MMPivot Medical · 2011 · 2 generations on2descendants
K193402ALLthread PEEK Suture AnchorBiomet, Inc. · 2020 · 2 generations on0descendants
K192942ALLthread Titanium Suture AnchorBiomet, Inc. · 2020 · cites it directly0descendants
K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine · 2013 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K943806	Harpoon Suture Anchors	Biomet, Inc.	1995	—
−1	K012503	Metal Screw Anchor	Biomet Manufacturing, Inc.	2001	—
0 (this device)	K042460	TI - Screw Anchor SP	Arthrotek, Inc.	2004	—
+1	K080088	Biomet Sports Medicine Anchor Devices and Ziploop Constructs	Biomet Manufacturing, Inc.	2008	8
+2	K110473	Nanotack Suture Anchor 1.4MM	Pivot Medical	2011	—
+2	K193402	ALLthread PEEK Suture Anchor	Biomet, Inc.	2020	—
+1	K192942	ALLthread Titanium Suture Anchor	Biomet, Inc.	2020	—
+2	K123485	Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless…	Biomet Sports Medicine	2013	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K042460, 1995–2020Source: 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
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What was it cleared against? (2)

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
*	K012503	Metal Screw Anchor Summary page 1 …Tissue 21 CFR §888.3040 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Metal Screw Anchor (K01 2503) -Biomet Inc. Harpoon and Mini Harpoon Suture Anchors (K973775) - Biomet Inc. Device Description: The…	Biomet Manufacturing, Inc.	2001	—
*	K973775	Harpoon Suture Anchors Summary page 1 …ch Substantial Equivalence Is Claimed: Metal Screw Anchor (K01 2503) -Biomet Inc. Harpoon and Mini Harpoon Suture Anchors (K973775) - Biomet Inc. Device Description: The Ti - Screw Anchor SP consists of a screw tip, a screw body, and an…	Biomet, Inc.	1998	—

Also cleared against K012503: 3 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K080088	Biomet Sports Medicine Anchor Devices and Ziploop Constructs	Biomet Manufacturing, Inc.	2008	6
K192942	ALLthread Titanium Suture Anchor	Biomet, Inc.	2020	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 9 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K080088 (Biomet Manufacturing, Inc., 2008) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K012503.

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 Ti-Screw Anchor SP is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows: Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand Indications - Ulnar/radial collateral ligament reconstruction. Ankle/Foot…

Read the full statement (109 words)

The Ti-Screw Anchor SP is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist/Hand Indications - Ulnar/radial collateral ligament reconstruction.

Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.

Elbow Indications - Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee Indications - Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042460 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042460: TI - Screw Anchor SP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042460

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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