510(k) Report

510(k) · Cleared

Cleared

Ortho Development Balanced Knee Tibial Tray Pegged

K020383510(k) TraditionalCleared May 6, 200290-day reviewClass II21 CFR 888.3560

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

Ortho Development Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on May 6, 2002 as substantially equivalent to K994370 (Ortho Development Corp., 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000.

Decided
May 6, 2002
Review
90 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K994370 (2000). No later device cites it as a predicate yet.

K994370 · Ortho Development Balanced Knee System · Ortho Development Corp. · 2000 · recalled200020022004
K994370 · Ortho Development Balanced Knee System · Ortho Development Corp. · 2000 · recalled0
  1. Root · 1 generation backK994370 Ortho Development Balanced Knee SystemOrtho Development Corp. · 2000 · Recalled
  2. This deviceK020383 Ortho Development Balanced Knee Tibial Tray PeggedOrtho Development Corp. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K994370Ortho Development Balanced Knee SystemOrtho Development Corp.20006
0 (this device)K020383Ortho Development Balanced Knee Tibial Tray PeggedOrtho Development Corp.2002—
FIG. 1 — Lineage of K020383, 2000–2002Source: 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 JWH? 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 JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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
*K994370Ortho Development Balanced Knee System
Summary page 1
…ment Balanced Knee™ Tibial Tray Pegged serves as an additional option to the tibial tray configurations currently offered in the Ortho Development Balanced Knee™ System, K994370, which include the tibial tray nonporous and the tibial tray porous. Materials: The devices are manufactured from forged Ti-6Al-…
Ortho Development Corp.20006
*—Balanced Knee™ System (Ortho Development)
Named without a submission number
—
*—Natural Knee System (Intermedics Orthopedics)
Named without a submission number
—
*—Ortholoc Advantim System (Wright Medical)
Named without a submission number
—
*—Consensus Knee System (Hayes Medical)
Named without a submission number
—

Also cleared against K994370: 5 other devices →

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?

  • Its one ancestor has a recall.
  • 5 other devices also cite its predicate K994370.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

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

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

What is it indicated for?

The Balanced Knee™ Tibial Tray Pegged is intended for single use in primary total knee replacement only. Indications include: « Loss of joint configuration and joint function; ¢ Osteoarthritis of the knee joint; e Rheumatoid arthritis of the knee joint; v Post-traumatic arthritis of the knee joint; » Moderate valgus, varus, or flexion deformities. The Ortho Development Balanced Knee™ Tibial Tray Pegged is indicated for patients suffering from severe knee…

Read the full statement (121 words)

The Balanced Knee™ Tibial Tray Pegged is intended for single use in primary total knee replacement only. Indications include:

« Loss of joint configuration and joint function;

¢ Osteoarthritis of the knee joint;

e Rheumatoid arthritis of the knee joint;

v Post-traumatic arthritis of the knee joint;

» Moderate valgus, varus, or flexion deformities.

The Ortho Development Balanced Knee™ Tibial Tray Pegged is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bane disease such as rheumatoid arthritis or ostaoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use oniy.

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 K994370

5 other devices cite the same predicate.

  • K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation · 2015
  • K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp. · 2013
  • K123457Balanced Knee System High Flex PSOrtho Development Corp. · 2013
  • K112906Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
  • K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 20091 recall

More from Ortho Development Corp.

45 FDA decisions under this applicant name. See the company

  • K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp. · 2025
  • K251052Trivicta® Hip StemOrtho Development Corp. · 2025
  • K242984BKS Revision SystemOrtho Development Corp. · 2024
  • K242833Legend® Acetabular ShellOrtho Development Corp. · 2024
  • K233758Trivicta™ Hip StemOrtho Development Corp. · 2024

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K020383 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020383: Ortho Development Balanced Knee Tibial Tray Pegged.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020383

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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