510(k) · Cleared

Cleared

Modification to Bone Mulch Screw System

K993025510(k) SpecialCleared Oct 8, 199929-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 Oct 8, 1999 as substantially equivalent to K941941 (Biomet, Inc., 1995) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.

Decided: Oct 8, 1999
Review: 29 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K941941 (1995). 2 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK941941 Bone Mulch ScrewBiomet, Inc. · 1995 · Recalled
This deviceK993025 Modification to Bone Mulch Screw SystemBiomet, Inc. · 1999
Descendant · cites it directly · 4 of its ownK042552 Bio-Core Interference ScrewBiomet, Inc. · 2004
Descendant · 2 generations on · 1 of its ownK140879 Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc. · 2014
Descendant · 2 generations on · 1 of its ownK071464 Inion Hexalon Biodegradable Acl/PCL ScrewInion OY · 2007
Descendant · 3 generations on · 0 of its ownK142948 BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · Recalled
Descendant · 3 generations on · 0 of its ownK130716 Bioretec Activascrew InterferenceBioretec, Ltd. · 2013

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002high 1 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all

K042552Bio-Core Interference ScrewBiomet, Inc. · 2004 · cites it directly4descendants
K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc. · 2014 · 2 generations on1descendant
K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY · 2007 · 2 generations on1descendant
K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · 3 generations on0descendants
K130716Bioretec Activascrew InterferenceBioretec, Ltd. · 2013 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941941	Bone Mulch Screw	Biomet, Inc.	1995	1
0 (this device)	K993025	Modification to Bone Mulch Screw System	Biomet, Inc.	1999	—
+1	K042552	Bio-Core Interference Screw	Biomet, Inc.	2004	—
+2	K140879	Biosure Healicoil PK Interference Screw	Smith & Nephew, Inc.	2014	—
+2	K071464	Inion Hexalon Biodegradable Acl/PCL Screw	Inion OY	2007	—
+3	K142948	BIOSURE REGENESORB interference Screw	Smith & Nephew, Inc.	2015	1
+3	K130716	Bioretec Activascrew Interference	Bioretec, Ltd.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2007	1	0
2013	1	0
2014	1	0
2015	1	0

FIG. 1 — Lineage of K993025, 1995–2015Source: 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

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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
*	K941941	Bone Mulch Screw Summary page 1 …Guidance Documents: No performance standards have been developed for this type of device Previous FDA Status: Devices from this system were previously cleared in 510(k) K941941 and K991298. Device Description: The predicate Bone Mulch Screw System consists of three different Bone Mulch Screws made of Tit…	Biomet, Inc.	1995	1
*	K991298	Bone Mulch Screw System Summary page 1 …uments: No performance standards have been developed for this type of device Previous FDA Status: Devices from this system were previously cleared in 510(k) K941941 and K991298. Device Description: The predicate Bone Mulch Screw System consists of three different Bone Mulch Screws made of Titanium alloy…	Biomet, Inc.	1999	—

Also cleared against K941941: 2 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K042552	Bio-Core Interference Screw	Biomet, Inc.	2004	4
K014305	Resorbable Lactosorb-L Acl Crosspin	Arthrotek, Inc.	2002	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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K042552 (Biomet, Inc., 2004) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate K941941.

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?

The Bone Mulch Screw System is indicated for use in anterior cruciate ligament (ACL) reconstruction using semigracilis/semitendinosus or fasc ... lata (namstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.

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/K993025 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993025: Modification to Bone Mulch Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993025

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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