510(k) · Cleared

Cleared

Silastic H.P. Trapexial Implant

K781756510(k) TraditionalCleared Nov 15, 197830-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

Dow Corning Corp. Healthcare Industries Materials · KYI Prosthesis, Wrist, Carpal Trapezium

Cleared on Nov 15, 1978 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Nov 15, 1978
Review: 30 days
Class: Class II
Product code: KYI
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK781756 Silastic H.P. Trapexial ImplantDow Corning Corp. Healthcare Industries Materials · 1978
Descendant · cites it directly · 1 of its ownK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009
Descendant · 2 generations on · 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 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K781756	Silastic H.P. Trapexial Implant	Dow Corning Corp. Healthcare Industries Materials	1978	—
+1	K092548	Extremity Medical Trapezium Prosthesis	Extremity Medical, LLC	2009	—
+2	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 K781756, 1978–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites 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

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	—

https://510kreport.com/device/K781756 · printed Nov 6, 2026

Cite this page

510(k) Report. “K781756: Silastic H.P. Trapexial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781756

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026