510(k) · Cleared

Cleared

Tie-in Trapezium

K033529510(k) SpecialCleared Dec 3, 200323-day reviewClass II21 CFR 888.3770

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

Wrightmedicaltechnologyinc · KYI Prosthesis, Wrist, Carpal Trapezium

Cleared on Dec 3, 2003 after a 23-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Dec 3, 2003
Review: 23 days
Class: Class II
Product code: KYI
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK033529 Tie-in TrapeziumWrightmedicaltechnologyinc · 2003
Descendant · cites it directly · 1 of its ownK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009
Descendant · cites it directly · 0 of its ownK201072 Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020

Most influential descendants

Showing 2 of 2 · See all

K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009 · cites it directly1descendant
K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K033529	Tie-in Trapezium	Wrightmedicaltechnologyinc	2003	—
+1	K092548	Extremity Medical Trapezium Prosthesis	Extremity Medical, LLC	2009	—
+1	K201072	Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161	Ensemble Orthopedics, LLC	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2020	1	0

FIG. 1 — Lineage of K033529, 2003–2020Source: 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 KYI? 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 KYI device

#1 K201072 Ensemble CMC, Size 141, Ensemble CMC, Size…score 1.9 · 6 generations · no Class I recall

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
*	—	Swanson Trapezium Implant Named without a submission number			—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K092548	Extremity Medical Trapezium Prosthesis	Extremity Medical, LLC	2009	1
K201072	Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161	Ensemble Orthopedics, LLC	2020	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?

Of its descendants, K092548 (Extremity Medical, LLC, 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KYI devices

KYI Prosthesis, Wrist, Carpal Trapezium: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYI

1in 2020

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KYI

Too few KYI 510(k)s in any year since 2007 to give a median.

Recalls per year · KYI

1in 2016

2007high 2 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KYI

1in 2024

2007high 72 (2011) · low 0 (2015)2025

MAUDE reports naming product code KYI, 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	2	—	0	32
2008	0	—	0	51
2009	1	—	0	56
2010	0	—	2	25
2011	2	—	0	72
2012	0	—	0	22
2013	0	—	0	23
2014	0	—	0	4
2015	0	—	0	0
2016	0	—	1	3
2017	0	—	0	0
2018	1	—	0	4
2019	0	—	0	14
2020	1	—	0	8
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	1
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

Use of the TIE-INTm Trapezium may be considered in degenerative or post-traumatic disabilities of the thumb basil joint with:

* Localized pain and palpable crepitation during circumduction movement with axial compression of involved thumb ("grind test")

* Decreased motion, decreased pinch and decreased grip strength

* X-ray evidence of arthritic changes of the trapeziometacarpal, trapezioscaphoid, trapeziotrapezoid, and trapezium second metacarpal joints, singly or in combination

* Associated unstable, stiff, or painful distal joints of thumb or swan-neck deformity

The TIE-INTM Trapezium is for single use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033529 · printed Nov 5, 2026

Cite this page

510(k) Report. “K033529: Tie-in Trapezium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033529

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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