510(k) Report

510(k) · Cleared

Cleared

Modular Thumb Implant, Models 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507

K052596510(k) TraditionalCleared Nov 15, 200555-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

Biopro, Inc. · KYI Prosthesis, Wrist, Carpal Trapezium

Cleared on Nov 15, 2005 as substantially equivalent to K864488 (Dow Corning Wright, 1987) after a 55-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.

Decided
Nov 15, 2005
Review
55 days
Class
Class II
Product code
KYI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K864488 (1987). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2020: 1 descendant clearedK864488 · Swanson Titanium Condylar Implant · Dow Corning Wright · 19871990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K864488 · Swanson Titanium Condylar Implant · Dow Corning Wright · 19870
  1. Root · 1 generation backK864488 Swanson Titanium Condylar ImplantDow Corning Wright · 1987
  2. This deviceK052596 Modular Thumb Implant, Models…Biopro, Inc. · 2005
  3. Descendant · cites it directly · 1 of its ownK111068 Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011
  4. 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
  • K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC · 2011 · 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K864488Swanson Titanium Condylar ImplantDow Corning Wright1987—
0 (this device)K052596Modular Thumb Implant, Models…Biopro, Inc.2005—
+1K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC2011—
+2K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
202010
FIG. 1 — Lineage of K052596, 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 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 2
…used is Ethylene Oxide. Substantial Equivalence: The Biopro Modular Thumb implant is claimed to be substantially equivalent to the Swanson Titanium Condylar Implant (K864488). Both devices resurface the proximal end of the first metacarpal. They have intramedullary stems with a head that acts as a joi…
Dow Corning Wright1987—

Also cleared against K864488: 2 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K111068Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5Skeletal Dynamics, LLC20111

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, K111068 (Skeletal Dynamics, LLC, 2011) has gone furthest, with 1 descendant 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?

1. Rheumatoid arthritis

2. Traumatic arthritis

3. Osteoarthritis

4. Post Fracture deformation or bone loss

Indications for use as stated in the FDA summary.

Also cleared against K864488

2 other devices cite the same predicate.

  • K041451Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50Ascension Orthopedics, Inc. · 20042 recalls
  • K964472Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentBiologically Oriented Prostheses · 1997

More from Biopro, Inc.

41 FDA decisions under this applicant name. See the company

  • K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc. · 2017
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017
  • K132510Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013
  • K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
  • K121973Biopro Hemi-Edge Toe SystemBiopro, Inc. · 2012

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/K052596 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052596: Modular Thumb Implant, Models 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052596

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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