510(k) · Cleared

Cleared

Metal Screw Anchor

K012503510(k) TraditionalCleared Oct 22, 200180-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 Manufacturing, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Oct 22, 2001 as substantially equivalent to K943806 (Biomet, Inc., 1995) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1995. 17 later devices descend from it.

Decided: Oct 22, 2001
Review: 80 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K943806 (1995). 2 ancestors in all. 17 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
This deviceK012503 Metal Screw AnchorBiomet Manufacturing, Inc. · 2001
Descendant · cites it directly · 7 of its ownK071520 Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
Descendant · cites it directly · 7 of its ownK042460 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 · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
Descendant · 2 generations on · 2 of its ownK110473 Nanotack Suture Anchor 1.4MMPivot Medical · 2011

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2004high 3 (2013) · low 0 (2005)2026

Most influential descendants

Showing 5 of 17 · See all

K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007 · cites it directly7descendants
K042460TI - Screw Anchor SPArthrotek, Inc. · 2004 · cites it directly7descendants
K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 2008 · cites it directly6descendants
K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · 2 generations on3descendants
K110473Nanotack Suture Anchor 1.4MMPivot Medical · 2011 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943806	Harpoon Suture Anchors	Biomet, Inc.	1995	—
0 (this device)	K012503	Metal Screw Anchor	Biomet Manufacturing, Inc.	2001	—
+1	K071520	Renovo Suture Anchors, Models 100-2001 Thru 100-5502X	Core Essence Orthopaedics, LLC	2007	—
+1	K042460	TI - Screw Anchor SP	Arthrotek, Inc.	2004	—
+1	K080088	Biomet Sports Medicine Anchor Devices and Ziploop Constructs	Biomet Manufacturing, Inc.	2008	8
+2	K101126	Pontis Sutures and Suture Anchors with Optional Crimps	Core Essence Orthopaedics, Inc.	2010	—
+2	K110473	Nanotack Suture Anchor 1.4MM	Pivot Medical	2011	—

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
2004	1	0
2007	2	0
2008	1	0
2009	1	0
2010	1	0
2011	2	0
2013	3	0
2014	2	0
2015	1	0
2020	3	0

FIG. 1 — Lineage of K012503, 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
#3 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
*	K943806	Harpoon Suture Anchors Our OCR of the scanned summary read K943808, FDA’s number for Rionet HM-02 (Rockwin Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Harpoon Suture Anchor (Biomet, Inc.)”.	Biomet, Inc.	1995	—
*	K973775	Harpoon Suture Anchors Summary page 1 …ble, Soft Tissue Device Product Code: 87MBI and 87HWC Legally Marketed Devices To Which Substantial Equivalence is Clalmed: Harpoon Suture Anchor (Biomet, Inc., K943808/K973775) Indicatlons for Use: Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder,…	Biomet, Inc.	1998	—

Also cleared against K943806: 3 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K071520	Renovo Suture Anchors, Models 100-2001 Thru 100-5502X	Core Essence Orthopaedics, LLC	2007	7
K042460	TI - Screw Anchor SP	Arthrotek, Inc.	2004	7
K080088	Biomet Sports Medicine Anchor Devices and Ziploop Constructs	Biomet Manufacturing, Inc.	2008	6
K071816	Harpoon Suture Anchor	Biomet Sports Medicine, Inc.	2007	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?

None of the 2 ancestors has a recall.
Of its descendants, K071520 (Core Essence Orthopaedics, LLC, 2007) has gone furthest, with 7 descendants of its own.
3 other devices also cite its predicate K943806.

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?

Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications are as follows: Shoulder Indications — Bankart repair, SLAP lesion repair, acromioclavicular separation, rotator cuff repair, capsule repair, or capsulolabral reconstruction, biceps tenodesis, and deltoid repair. Wrist/Hand Indications — Scapholunate ligament reconstruction, and ulnar/radial collateral…

Read the full statement (114 words)

Indications for the Metal Screw Anchor include use in soft tissue reattachment procedures in the shoulder, wrist, elbow, and knee.

Specific indications are as follows:

Shoulder Indications — Bankart repair, SLAP lesion repair, acromioclavicular separation, rotator cuff repair, capsule repair, or capsulolabral reconstruction, biceps tenodesis, and deltoid repair.

Wrist/Hand Indications — Scapholunate ligament reconstruction, and 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, and biceps tendon reconstruction.

Knee Indications — Medial collateral ligament repair, lateral collateral ligament repair, posterior aoblique ligament repair, joint capsule closure, lliotibial band tenodesis, and patellar ligament/tendon 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/K012503 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012503: Metal Screw Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012503

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026