510(k) Report

510(k) · Cleared

Cleared

Evolution Unicondylar Knee System

K100973510(k) TraditionalCleared Aug 10, 2010124-day reviewClass II21 CFR 888.3530

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Cleared on Aug 10, 2010 as substantially equivalent to K881779 (Dow Corning Wright, 1988) and 5 other predicates after a 124-day review. Its family tree reaches back 2 generations to 1988.

Decided
Aug 10, 2010
Review
124 days
Class
Class II
Product code
HRY
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K881779 (1988). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2003: 1 other ancestor2001: 1 other ancestor1997: 1 other ancestorK881779 · Whiteside Ortholoc II Unicondylar Knee System · Dow Corning Wright · 1988K014171 · Advance Unicondylar Knee System · Wrightmedicaltechnologyinc · 2002198519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors K014171 · Advance Unicondylar Knee System · Wrightmedicaltechnologyinc · 2002K881779 · Whiteside Ortholoc II Unicondylar Knee System · Dow Corning Wright · 19880
  1. Root · 2 generations backK881779 Whiteside Ortholoc II Unicondylar Knee SystemDow Corning Wright · 1988
  2. 1 generation backK014171 Advance Unicondylar Knee SystemWrightmedicaltechnologyinc · 2002
  3. This deviceK100973 Evolution Unicondylar Knee SystemWrightmedicaltechnologyinc · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K881779Whiteside Ortholoc II Unicondylar Knee SystemDow Corning Wright1988—
−1K014171Advance Unicondylar Knee SystemWrightmedicaltechnologyinc2002—
0 (this device)K100973Evolution Unicondylar Knee SystemWrightmedicaltechnologyinc2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
200310
201010
FIG. 1 — Lineage of K100973, 1988–2010Source: 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 HRY? 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 HRY device

  1. #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (6)

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
*K881779Whiteside Ortholoc II Unicondylar Knee System
Summary page 1
…ongruent Tibial Insert EVOLUTION TM MP Total Knee System 510(k)s: K881779, K012591, K014171, K030193, K972770, K093552 DEVICE INFORMATION A. Intended…
Dow Corning Wright1988—
*K012591Advance Unicondylar Knee System
Summary page 1
…Tibial Insert EVOLUTION TM MP Total Knee System 510(k)s: K881779, K012591, K014171, K030193, K972770, K093552 DEVICE INFORMATION A. Intended Use…
Wrightmedicaltechnologyinc2001—
*K014171Advance Unicondylar Knee System
Summary page 1
…sert EVOLUTION TM MP Total Knee System 510(k)s: K881779, K012591, K014171, K030193, K972770, K093552 DEVICE INFORMATION A. Intended Use The EVOL…
Wrightmedicaltechnologyinc2002—
*K030193Advance Less Conforming Tibial Component
Summary page 1
…EVOLUTION TM MP Total Knee System 510(k)s: K881779, K012591, K014171, K030193, K972770, K093552 DEVICE INFORMATION A. Intended Use The EVOLUTION TM…
Wrightmedicaltechnologyinc2003—
*K972770Advance Ultra-Congruent Tibial Insert
Summary page 1
…MP Total Knee System 510(k)s: K881779, K012591, K014171, K030193, K972770, K093552 DEVICE INFORMATION A. Intended Use The EVOLUTION TM Unicondylar Knee System is indicated for use in knee arthropl…
Wrightmedicaltechnologyinc19972
*K093552Evolution MP Total Knee System
Summary page 1
…Knee System 510(k)s: K881779, K012591, K014171, K030193, K972770, K093552 DEVICE INFORMATION A. Intended Use The EVOLUTION TM Unicondylar Knee System is indicated for use in knee arthroplasty in s…
Wrightmedicaltechnologyinc20105

Also cleared against K881779: 1 other device →

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.

What does this lineage say?

  • The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 13.5 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • 1 other device also cites its predicate K881779.

How does its category compare?

All HRY devices

HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HRY

1in 2020

2007: 32008: 32010: 12011: 12012: 12013: 12014: 12015: 12016: 12019: 12020: 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRY

138in 2008

2007: 92 days median2008: 138 days median
2007high 138 (2008) · low 92 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRY

3in 2022

2007: 12008: 12011: 12013: 12016: 12020: 12021: 12022: 3
2007high 3 (2022) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRY

290in 2025

2007: 2632008: 2852009: 2492010: 1802011: 1552012: 1372013: 3832014: 3052015: 3452016: 3432017: 4022018: 6132019: 3672020: 1,0542021: 1,2182022: 8402023: 3962024: 4302025: 290
2007high 1,218 (2021) · low 137 (2012)2025

MAUDE reports naming product code HRY, 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
20073921263
200831381285
20090—0249
20101—0180
20111—1155
20121—0137
20131—1383
20141—0305
20151—0345
20161—1343
20170—0402
20180—0613
20191—0367
20201—11,054
20210—11,218
20220—3840
20230—0396
20240—0430
20250—0290
20260—0—

What is it indicated for?

The EVOLUTION TM Unicondylar Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. noninflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2. correction of functional deformity; 3. revision procedures where other treatments or devices have failed: and treatment of fractures that are unmanageable using other techniques. The EVOLUTION"T…

Read the full statement (99 words)

The EVOLUTION TM Unicondylar Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

2. correction of functional deformity;

3. revision procedures where other treatments or devices have failed: and treatment of fractures that are unmanageable using other techniques.

The EVOLUTION"T Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.

The EVOLUTION' Tm Unicondylar Knee System isfor cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K881779

1 other device cites the same predicate.

  • K014171Advance Unicondylar Knee SystemWrightmedicaltechnologyinc · 2002

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311 FDA decisions under this applicant name. See the company

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Recent decisions in HRY

The HRY category page

  • K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC · 2020
  • K190633NanoOrtho NanoKnee® SystemNanoortho, LLC · 2019
  • K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc. · 2016
  • K150410Restoris Porous Partial Knee SystemMako Surgical Corporation · 2015
  • K133940Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. · 20144 recalls

https://510kreport.com/device/K100973 · printed Nov 4, 2026

Cite this page

510(k) Report. “K100973: Evolution Unicondylar Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100973

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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