510(k) Report

510(k) · Cleared

Cleared

Extremity Medical Trapezium Prosthesis

K092548510(k) TraditionalCleared Dec 15, 2009118-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

Extremity Medical, LLC · KYI Prosthesis, Wrist, Carpal Trapezium

Cleared on Dec 15, 2009 as substantially equivalent to K960534 (Wrightmedicaltechnologyinc, 1997) and 7 other predicates after a 118-day review. Its family tree reaches back 5 generations to 1987. 1 later device descends from it.

Decided
Dec 15, 2009
Review
118 days
Class
Class II
Product code
KYI
Recalls
None
Predicates
8

Its longest line of descent runs back 5 generations to K864488 (1987). 13 ancestors in all, the oldest K781756 (1978). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 2 other ancestors1997: 2 other ancestors1987: 2 other ancestors1978: 1 other ancestor2020: 1 descendant clearedK864488 · Swanson Titanium Condylar Implant · Dow Corning Wright · 1987K964472 · Riopro Cobalt Trapeziometarcarpal Resurfacing Component · Biologically Oriented Prostheses · 1997K041451 · Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 · Ascension Orthopedics, Inc. · 2004 · recalledK061451 · Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 · Ascension Orthopedics, Inc. · 2006 · recalledK080997 · Ascension Pyrocarbon Lunate · Ascension Orthopedics, Inc. · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K080997 · Ascension Pyrocarbon Lunate · Ascension Orthopedics, Inc. · 2008K061451 · Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 · Ascension Orthopedics, Inc. · 2006 · recalledK041451 · Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 · Ascension Orthopedics, Inc. · 2004 · recalledK964472 · Riopro Cobalt Trapeziometarcarpal Resurfacing Component · Biologically Oriented Prostheses · 1997K864488 · Swanson Titanium Condylar Implant · Dow Corning Wright · 1987−50
  1. Root · 5 generations backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
  2. 4 generations backK964472 Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
  3. 3 generations backK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004 · Recalled
  4. 2 generations backK061451 Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · Recalled
  5. 1 generation backK080997 Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008
  6. This deviceK092548 Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009
  7. 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 1 of 1 · See all
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−5K864488Swanson Titanium Condylar ImplantDow Corning Wright1987—
−4K964472Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses1997—
−3K041451Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc.20042
−2K061451Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc.20061
−1K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc.2008—
0 (this device)K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC2009—
+1K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198720
199720
200320
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K092548, 1987–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K201072 Ensemble CMC, Size 141, Ensemble CMC, Size…score 2.0 · 6 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K960534Metallic Spherical CMC Implant
Summary page 1
…carpal trapezium polymer prosthesis and Number 21 CFR 888.3770 Product Code KYI Predicate Devices Wright Medical, Metallic CMIC Spherical Implant K960534 Wright Medical, Orthosphere Ceramic Spherical Implant, K030319…
Wrightmedicaltechnologyinc1997—
*K030319Orthosphere Ceramic Spherical Implant
Summary page 1
…te Devices Wright Medical, Metallic CMIC Spherical Implant K960534 Wright Medical, Orthosphere Ceramic Spherical Implant, K030319 Wright Medical, Swanson Titanium Carpal Scaphoid Implant, K864490…
Wrightmedicaltechnologyinc2003—
*K864490Swanson Titanium Carpal Scaphoid Implant
Summary page 1
…rthosphere Ceramic Spherical Implant, K030319 Wright Medical, Swanson Titanium Carpal Scaphoid Implant, K864490 Wright Medical, Swanson Titanium Carnal Lunate Implant, K864491…
Dow Corning Wright1987—
*K864491Swanson Titanium Carpal Lunate Implant
Summary page 1
…anson Titanium Carpal Scaphoid Implant, K864490 Wright Medical, Swanson Titanium Carnal Lunate Implant, K864491 Wright Medical, TIE-IN Trapezium, K033529 Wright Medical, Trapezium Implant, K78 1756…
Dow Corning Wright1987—
*K033529Tie-in Trapezium
Summary page 1
…64490 Wright Medical, Swanson Titanium Carnal Lunate Implant, K864491 Wright Medical, TIE-IN Trapezium, K033529 Wright Medical, Trapezium Implant, K78 1756 Ascension Orthopedics, PyroSphere, K04269…
Wrightmedicaltechnologyinc2003—
*K781756Silastic H.P. Trapexial Implant
Summary page 1
…al Lunate Implant, K864491 Wright Medical, TIE-IN Trapezium, K033529 Wright Medical, Trapezium Implant, K78 1756 Ascension Orthopedics, PyroSphere, K042690 Ascension Orthopedics, PyroCarbon Lunate,…
Dow Corning Corp. Healthcare Industries Materials1978—
*K042690Ascension Pyrosphere (PCS)
Summary page 1
…Wright Medical, TIE-IN Trapezium, K033529 Wright Medical, Trapezium Implant, K78 1756 Ascension Orthopedics, PyroSphere, K042690 Ascension Orthopedics, PyroCarbon Lunate, K080997 Device Description The EXTREMITY MEDICAL Trapezium P…
Ascension Orthopedics, Inc.2004—
*K080997Ascension Pyrocarbon Lunate
Summary page 1
…ght Medical, Trapezium Implant, K78 1756 Ascension Orthopedics, PyroSphere, K042690 Ascension Orthopedics, PyroCarbon Lunate, K080997 Device Description The EXTREMITY MEDICAL Trapezium Prosthesis Indications for use The Extremity Medical Tr…
Ascension Orthopedics, Inc.2008—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC20200

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?

  • The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
  • 2 of the 13 ancestors have a recall of any class.
  • Of its descendants, K201072 (Ensemble Orthopedics, LLC, 2020) has gone furthest, with 0 descendants 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. 2009, this device’s year, is highlighted.

FDA decisions per year · KYI

1in 2020

2007: 22009: 12011: 22018: 12020: 1
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

2010: 22016: 1
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

2007: 322008: 512009: 562010: 252011: 722012: 222013: 232014: 42016: 32018: 42019: 142020: 82024: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—032
20080—051
20091—056
20100—225
20112—072
20120—022
20130—023
20140—04
20150—00
20160—13
20170—00
20181—04
20190—014
20201—08
20210—00
20220—00
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

The Extremity Medical Trapezium Prosthesis is indicated for use in degenierative or post-traumnatic (e.gu. following an old Bennett fracture) disabilities of the thumb basal joint with:

- Localized pain and palpable crepitation at the base of the thumb onl the "grind test" (circumduction with axial compression of the thumb)

- Decreased motion, pinch; and 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

Indications for use as stated in the FDA summary.

More from Extremity Medical, LLC

28 FDA decisions under this applicant name. See the company

  • K250536MetaFore Small Screw SystemExtremity Medical, LLC · 2025
  • K251128Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  • K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
  • K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC · 2021
  • K211261Axis Charcot Fixation SystemExtremity Medical, LLC · 2021

Recent decisions in KYI

The KYI category page

  • K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC · 2020
  • K180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLC · 2018
  • K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011
  • K112278Ascension Nugrip CMC ImplantAscension Orthopedic · 2011
  • K061956Artelon STT SpacerArtimplant AB · 2007

https://510kreport.com/device/K092548 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092548: Extremity Medical Trapezium Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092548

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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