510(k) · Cleared

Cleared

Mitek BTB Absorbable (Pla) Cross Pin

K974291510(k) TraditionalCleared Mar 5, 1998111-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

Mitek Products · HTY Pin, Fixation, Smooth

Cleared on Mar 5, 1998 as substantially equivalent to K960940 (Linvatec Corp., 1996) after a 111-day review. Its family tree reaches back 1 generation to 1996. 3 later devices descend from it.

Decided: Mar 5, 1998
Review: 111 days
Class: Class II
Product code: HTY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K960940 (1996). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK960940 Bioscrew Absorbable Interference ScrewLinvatec Corp. · 1996
This deviceK974291 Mitek BTB Absorbable (Pla) Cross PinMitek Products · 1998
Descendant · cites it directly · 2 of its ownK090669 Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company · 2009
Descendant · 2 generations on · 1 of its ownK091041 Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and…Depuy Mitek, A Johnson & Johnson Company · 2009
Descendant · 2 generations on · 0 of its ownK130105 Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl…Depuy Mitek, A Johnson & Johnson Company · 2013

Most influential descendants

Showing 3 of 3 · See all

K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company · 2009 · cites it directly2descendants
K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST…Depuy Mitek, A Johnson & Johnson Company · 2009 · 2 generations on1descendant
K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company · 2013 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960940	Bioscrew Absorbable Interference Screw	Linvatec Corp.	1996	—
0 (this device)	K974291	Mitek BTB Absorbable (Pla) Cross Pin	Mitek Products	1998	—
+1	K090669	Rigidfix Biocryl Cross Pin Kits	Depuy Mitek, A Johnson & Johnson Company	2009	—
+2	K091041	Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial…	Depuy Mitek, A Johnson & Johnson Company	2009	—
+2	K130105	Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross…	Depuy Mitek, A Johnson & Johnson Company	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2013	1	0

FIG. 1 — Lineage of K974291, 1996–2013Source: 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 HTY? 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 HTY device

#1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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? (1)

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
*	K960940	Bioscrew Absorbable Interference Screw Summary page 1 …llowing surgery allowing the natural healing process(es) to occur. COMPARISON TO PREDICATE DEVICE The Cross Pin compares to the predicate device, Linvatec Bioscrew, (K)960940, in that it is made from the same type of material (PLA), and is used to hold the bone graft in place in the femoral tunnel durin…	Linvatec Corp.	1996	—

Also cleared against K960940: 2 other devices →

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K090669	Rigidfix Biocryl Cross Pin Kits	Depuy Mitek, A Johnson & Johnson Company	2009	2

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?

Its one ancestor has no recall.
Of its descendants, K090669 (Depuy Mitek, A Johnson & Johnson Company, 2009) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K960940.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTY

5in 2025

2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007high 180 (2010) · low 73 (2014)2026

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

Recalls per year · HTY

2in 2022

2007high 2 (2016) · low 0 (2007)2026

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

Adverse event reports per year · HTY

39in 2025

2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, 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	6	112	0	46
2008	6	86	0	38
2009	2	—	1	36
2010	9	180	1	33
2011	6	82	0	164
2012	4	76	0	129
2013	4	128	0	187
2014	8	73	0	149
2015	8	101	0	121
2016	6	114	2	128
2017	5	127	0	82
2018	4	162	0	138
2019	4	93	1	222
2020	5	108	0	210
2021	5	137	0	148
2022	4	121	2	96
2023	5	146	0	153
2024	1	—	0	297
2025	5	90	0	39
2026	2	—	1	—

What is it indicated for?

Femoral fixation of autograft or allograft ACL Bone Tendon Bone Grafts

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/K974291 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974291: Mitek BTB Absorbable (Pla) Cross Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974291

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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