510(k) · Cleared

Cleared

Rididfix 2.7MM BTB Cross Pin Kit

K013781510(k) TraditionalCleared Feb 6, 200284-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 Feb 6, 2002 as substantially equivalent to K973758 (Linvatec Corp., 1998) after an 84-day review. Its family tree reaches back 1 generation to 1998. 3 later devices descend from it.

Decided: Feb 6, 2002
Review: 84 days
Class: Class II
Product code: HTY
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K973758 (1998). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK973758 Bioscrew Absorbable Interference SrewLinvatec Corp. · 1998
This deviceK013781 Rididfix 2.7MM BTB Cross Pin KitMitek Products · 2002
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	K973758	Bioscrew Absorbable Interference Srew	Linvatec Corp.	1998	—
0 (this device)	K013781	Rididfix 2.7MM BTB Cross Pin Kit	Mitek Products	2002	—
+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 K013781, 1998–2013Source: 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K097429	Mitek RigidFix™ 2.7mm BTB Cross Pin Kit Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*	K973758	Bioscrew Absorbable Interference Srew Summary page 1 …sification is Class II, Performance Standards. Predicate Devices: Mitek - RigidFix™ 2.7mm BTB Cross Pin Kit (K97429 1) Linvatec BioScrew® Absorbable Interference Screw (K973758) All of the devices mentioned above have been determined substantially equivalent by FDA. Device Description: The device descri…	Linvatec Corp.	1998	—

Also cleared against K973758: 9 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.
9 other devices also cite its predicate K973758.

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?

The Mitek RigidFix 2.7mm BTB Cross Pin Kit is indicated for femoral and tibial 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/K013781 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013781: Rididfix 2.7MM BTB Cross Pin Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013781

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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