510(k) · Cleared

Cleared

Soft Tissue Screw and Washer

K012572510(k) TraditionalCleared Dec 3, 2001116-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. · HWC Screw, Fixation, Bone

Cleared on Dec 3, 2001 as substantially equivalent to K973775 (Biomet, Inc., 1998) and 3 other predicates after a 116-day review. Its family tree reaches back 1 generation to 1994. 47 later devices descend from it.

Decided: Dec 3, 2001
Review: 116 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K931519 (1994). 4 ancestors in all. 47 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK931519 Acufex SuretacAcufex Microsurgical, Inc. · 1994
This deviceK012572 Soft Tissue Screw and WasherBiomet, Inc. · 2001
Descendant · cites it directly · 26 of its ownK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
Descendant · cites it directly · 15 of its ownK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
Descendant · 2 generations on · 13 of its ownK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
Descendant · cites it directly · 9 of its ownK070389 Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · Recalled
Descendant · cites it directly · 8 of its ownK061657 Hitch Lactosorb Suture AnchorArthrotek, Inc. · 2006

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2004high 6 (2011) · low 0 (2019)2026

Most influential descendants

Showing 5 of 47 · See all

K041274Resorbable Interference ScrewArthrotek, Inc. · 2004 · cites it directly26descendants
K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc. · 2004 · cites it directly15descendants
K052080Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005 · 2 generations on13descendants
K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc. · 2007 · cites it directly9descendants
K061657Hitch Lactosorb Suture AnchorArthrotek, Inc. · 2006 · cites it directly8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931519	Acufex Suretac	Acufex Microsurgical, Inc.	1994	—
0 (this device)	K012572	Soft Tissue Screw and Washer	Biomet, Inc.	2001	—
+1	K041274	Resorbable Interference Screw	Arthrotek, Inc.	2004	5
+1	K032894	Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T…	Linvatec Biomaterials, Inc.	2004	—
+2	K052080	Matryx Interference Screw	Linvatec Biomaterials, Inc.	2005	—
+1	K070389	Peek Knotless Anchors	Biomet Sports Medicine, Inc.	2007	1
+1	K061657	Hitch Lactosorb Suture Anchor	Arthrotek, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1998	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	4	0
2005	2	0
2006	2	0
2007	4	0
2008	3	0
2009	1	0
2010	2	0
2011	6	0
2012	3	0
2013	4	0
2014	2	0
2015	1	0
2016	2	0
2017	2	0
2018	3	0
2020	4	0
2022	1	0
2023	1	0

FIG. 1 — Lineage of K012572, 1994–2023Source: 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 HWC? 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 HWC device

#1 K203011 Monster Screw Systemscore 22.2 · 14 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? (5)

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
*	K973775	Harpoon Suture Anchors Summary page 1 …, Biodegradable soft tissue Device Product Code: 87MAI Legally Marketed Devices To Which Substantial Equivalence is Claimed: Mini Harpoon® Suture Anchor (Biomet, Inc., K973775), Acufex’s Suretac® (Acufex, K931519), Resorbable Bone Pin (Biomet, Inc., KO11522), Mitek GlI Anchor (Mitek Surgical Products, In…	Biomet, Inc.	1998	—
*	K931519	Acufex Suretac Summary page 1 …oduct Code: 87MAI Legally Marketed Devices To Which Substantial Equivalence is Claimed: Mini Harpoon® Suture Anchor (Biomet, Inc., K973775), Acufex’s Suretac® (Acufex, K931519), Resorbable Bone Pin (Biomet, Inc., KO11522), Mitek GlI Anchor (Mitek Surgical Products, Inc., K953877), Quick Anchor Plus (Mite…	Acufex Microsurgical, Inc.	1994	—
*	K011522	Resorbable Bone Pins	Biomet, Inc.	2001	—
*	K953877	Mitek Gii Anchor Summary page 1 …Suture Anchor (Biomet, Inc., K973775), Acufex’s Suretac® (Acufex, K931519), Resorbable Bone Pin (Biomet, Inc., KO11522), Mitek GlI Anchor (Mitek Surgical Products, Inc., K953877), Quick Anchor Plus (Mitek Surgical Products, Inc., 510(k) number unknown). Indications for Screw and Washer: Shoulder Indicati…	Mitek Surgical Products, Inc.	1995	—
*	—	Quick Anchor Plus Named without a submission number			—

Also cleared against K973775: 7 other devices →

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K041274	Resorbable Interference Screw	Arthrotek, Inc.	2004	26
K032894	Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…	Linvatec Biomaterials, Inc.	2004	15
K070389	Peek Knotless Anchors	Biomet Sports Medicine, Inc.	2007	9
K061657	Hitch Lactosorb Suture Anchor	Arthrotek, Inc.	2006	8
K040475	Micromax Suture Anchor	Biomet, Inc.	2004	7
K081172	Composite Hitch Suture Anchor	Biomet Manufacturing Corp	2008	0
K080447	Surgicraft Screw Fixation System	Surgicraft, Ltd.	2008	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 4 ancestors has a recall.
Of its descendants, K041274 (Arthrotek, Inc., 2004) has gone furthest, with 26 descendants of its own.
7 other devices also cite its predicate K973775.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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	35	77	25	669
2008	33	76	33	660
2009	27	113	29	651
2010	23	110	7	765
2011	35	88	12	1,104
2012	20	99	30	3,339
2013	25	90	14	3,850
2014	31	88	2	2,549
2015	41	85	5	2,711
2016	26	131	4	2,285
2017	40	127	4	2,561
2018	20	106	1	3,662
2019	30	108	5	5,463
2020	28	75	4	4,820
2021	26	84	2	4,446
2022	26	167	13	3,934
2023	24	104	0	3,718
2024	17	90	0	3,575
2025	15	111	1	2,893
2026	21	125	2	—

What is it indicated for?

Indications for Screw and Washer: Shoulder Indications: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair and capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist Indications: Scapholunate ligament reconstruction. Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction. Knee Indications…

Read the full statement (100 words)

Indications for Screw and Washer:

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

Wrist Indications: Scapholunate ligament reconstruction.

Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

Knee Indications: Extra-capsular repair. Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

The Soft Tissue Screw and Washer is preloaded with suture for use at the discretion of the physician.

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/K012572 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012572: Soft Tissue Screw and Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012572

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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