510(k) · Cleared

Recalled · 2005

Biosteon Cross Pin

K021351510(k) TraditionalCleared Oct 17, 2002171-day reviewClass II21 CFR 888.3040Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biocomposites, Ltd. · HWC Screw, Fixation, Bone

Cleared on Oct 17, 2002 as substantially equivalent to K011172 (Arthrex, Inc., 2001) and 1 other predicate after a 171-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it. It has been recalled once.

Decided: Oct 17, 2002
Review: 171 days
Class: Class II
Product code: HWC
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K003641 (2001). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003641 Biolok Screw, Biosteon ScrewBiocomposites, Ltd. · 2001
This deviceK021351 Biosteon Cross PinBiocomposites, Ltd. · 2002
Descendant · cites it directly · 0 of its ownK033792 Bilok ST ScrewBiocomposites, Ltd. · 2004

Most influential descendants

Showing 1 of 1 · See all

K033792Bilok ST ScrewBiocomposites, Ltd. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003641	Biolok Screw, Biosteon Screw	Biocomposites, Ltd.	2001	—
0 (this device)	K021351	Biosteon Cross Pin	Biocomposites, Ltd.	2002	—
+1	K033792	Bilok ST Screw	Biocomposites, Ltd.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K021351, 2001–2004Source: 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
*	K011172	Arthrex Bio-Transfix	Arthrex, Inc.	2001	—
*	K003641	Biolok Screw, Biosteon Screw Summary page 1 …uction and methods of manufacture, packaging and sterilization of the Biosteon Cross Pin are identical to the previously cleared Biosteon Screw K003641. The function and indications for use of the Biosteon Cross Pin are the same as for the Arthrex Bi…	Biocomposites, Ltd.	2001	—

Also cleared against K011172: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033792	Bilok ST Screw	Biocomposites, Ltd.	2004	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 23, 2005	Not classified	Z-0165-06	Other	The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surgery delay.

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, K033792 (Biocomposites, Ltd., 2004) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K011172.

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 Biosteon® cross pin is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.

The Biosteon® cross pin is used to provide suspension fixation during femoral fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021351 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021351: Biosteon Cross Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021351

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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