510(k) Report

510(k) · Cleared

Cleared

Riopro Cobalt Trapeziometarcarpal Resurfacing Component

K964472510(k) TraditionalCleared Feb 3, 199788-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

Biologically Oriented Prostheses · KYI Prosthesis, Wrist, Carpal Trapezium

Cleared on Feb 3, 1997 as substantially equivalent to K864488 (Dow Corning Wright, 1987) after an 88-day review. Its family tree reaches back 1 generation to 1987. 9 later devices descend from it.

Decided
Feb 3, 1997
Review
88 days
Class
Class II
Product code
KYI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K864488 (1987). 9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2006: 2 descendants cleared2011: 2 descendants cleared2020: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant clearedK864488 · Swanson Titanium Condylar Implant · Dow Corning Wright · 19871990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 5 descendants K864488 · Swanson Titanium Condylar Implant · Dow Corning Wright · 19870
  1. Root · 1 generation backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
  2. This deviceK964472 Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997
  3. Descendant · cites it directly · 8 of its ownK041451 Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30…Ascension Orthopedics, Inc. · 2004 · Recalled
  4. Descendant · 2 generations on · 5 of its ownK061451 Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · Recalled
  5. Descendant · 2 generations on · 3 of its ownK042690 Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc. · 2004
  6. Descendant · 3 generations on · 2 of its ownK080997 Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008
  7. Descendant · 3 generations on · 1 of its ownK111068 Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004: 22006: 22008: 12009: 12011: 22020: 1
2004high 2 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 9 · See all
  • K041451Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40…Ascension Orthopedics, Inc. · 2004 · cites it directly8descendants
  • K061451Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40Ascension Orthopedics, Inc. · 2006 · 2 generations on5descendants
  • K042690Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc. · 2004 · 2 generations on3descendants
  • K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc. · 2008 · 3 generations on2descendants
  • K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K864488Swanson Titanium Condylar ImplantDow Corning Wright1987—
0 (this device)K964472Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses1997—
+1K041451Ascension 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
+2K042690Ascension Pyrosphere (PCS)Ascension Orthopedics, Inc.2004—
+3K080997Ascension Pyrocarbon LunateAscension Orthopedics, Inc.2008—
+3K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200620
200810
200910
201120
202010
FIG. 1 — Lineage of K964472, 1987–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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.

TypeNumberDeviceApplicantDecidedRecalls
*K864488Swanson Titanium Condylar Implant
Summary page 1
…apeziometacarpal Replacement Classification: The FDA has not yet created a classification for this type of device. Predicate Device: Swanson Titanium Condylar Implant (K864488) The BIOPRO Cobalt Trapeziometacarpal Replacement is a one-piece resurfacing component for the basal thumb joint. It has an anat…
Dow Corning Wright1987—

Also cleared against K864488: 2 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K041451Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40…Ascension Orthopedics, Inc.20048

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, K041451 (Ascension Orthopedics, Inc., 2004) has gone furthest, with 8 descendants of its own.
  • 2 other devices also cite its predicate K864488.

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

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 BIOPRO Cobalt Trapeziometacarpal Replacement is intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present themselves as either a painful, instable thumb or a thumb with limited range of motion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K864488

2 other devices cite the same predicate.

  • K052596Modular Thumb Implant, Models…Biopro, Inc. · 2005
  • K041451Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50Ascension Orthopedics, Inc. · 20042 recalls

More from Biologically Oriented Prostheses

9 FDA decisions under this applicant name. See the company

  • K002325Wujin #3 Tibial NailBiologically Oriented Prostheses · 2000
  • K992144Biopro Rimmed Acetabular CompomentBiologically Oriented Prostheses · 1999
  • K962769Horizon Hip SystemBiologically Oriented Prostheses · 1996
  • K955916Townley Total Elbow SystemBiologically Oriented Prostheses · 1996
  • K954768Biopro Hemi-Endo Modular Ceramic HeadBiologically Oriented Prostheses · 19961 recall

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
  • K092548Extremity Medical Trapezium ProsthesisExtremity Medical, LLC · 2009

https://510kreport.com/device/K964472 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964472: Riopro Cobalt Trapeziometarcarpal Resurfacing Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964472

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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