510(k) Report

510(k) · Cleared

Cleared

Osteonics 7000 Series Total Knee Tibial Components

K910990510(k) TraditionalCleared Jun 19, 1991104-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

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

Cleared on Jun 19, 1991 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.

Decided
Jun 19, 1991
Review
104 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

25 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2002: 1 descendant cleared2007: 1 descendant cleared2009: 2 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2017: 2 descendants cleared2014: 1 descendant cleared2016: 1 descendant cleared2025: 4 descendants cleared2024: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant cleared2013: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared2023: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK910990 Osteonics 7000 Series Total Knee Tibial ComponentsOsteonics Corp. · 1991
  2. Descendant · cites it directly · 23 of its ownK032829 Scorpio Low Profile Tibial TrayHowmedica Osteonics Corp. · 2003
  3. Descendant · 2 generations on · 15 of its ownK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
  4. Descendant · 3 generations on · 7 of its ownK091280 Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009
  5. Descendant · 3 generations on · 6 of its ownK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
  6. Descendant · 2 generations on · 6 of its ownK071499 Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc. · 2007

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12007: 12008: 12009: 22013: 12014: 12015: 22016: 12017: 22019: 12020: 12021: 22022: 12023: 12024: 12025: 42026: 1
2002high 4 (2025) · low 0 (2004)2026

Most influential descendants

Showing 5 of 25 · See all
  • K032829Scorpio Low Profile Tibial TrayHowmedica Osteonics Corp. · 2003 · cites it directly23descendants
  • K082019Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009 · 2 generations on15descendants
  • K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009 · 3 generations on7descendants
  • K131481Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014 · 3 generations on6descendants
  • K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc. · 2007 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K910990Osteonics 7000 Series Total Knee Tibial ComponentsOsteonics Corp.1991—
+1K032829Scorpio Low Profile Tibial TrayHowmedica Osteonics Corp.2003—
+2K082019Freedom Total Knee SystemMaxx Orthopedics, Inc.2009—
+3K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc.2009—
+3K131481Freedom PCK ComponentsMaxx Orthopedics, Inc.2014—
+2K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200710
200810
200920
201310
201410
201520
201610
201720
201910
202010
202120
202210
202310
202410
202540
202610
FIG. 1 — Lineage of K910990, 1991–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (25)

See all 25

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032829Scorpio Low Profile Tibial TrayHowmedica Osteonics Corp.200323
K020703Scorpio CR and PS CO CR Femoral Components with Titanium Plasma Spray CoatingHowmedica Osteonics Corp.20020

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?

  • Of its descendants, K032829 (Howmedica Osteonics Corp., 2003) has gone furthest, with 23 descendants of its own.

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—

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

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/K910990 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910990: Osteonics 7000 Series Total Knee Tibial Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910990

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026