510(k) Report

510(k) · Cleared

Cleared

Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599

K061089510(k) TraditionalCleared Jun 20, 200663-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 Jun 20, 2006 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jun 20, 2006
Review
63 days
Class
Class II
Product code
KYI
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K061089Source: FDA 510(k) database · 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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.

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 510(k) statement.

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/K061089 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061089: Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061089

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026